title: Cross-cultural Validation in French Language of the Questionnaire EARS Adapted to the Chronic Low Back Pain

acronym: EARS

summary:
The main objective of this work is to validate in French the questionnaire EARS, adapted to chronic low back pain.

Physical exercise is often recognized as necessary for primary and secondary prevention and treatment of chronic diseases. This is particularly true of chronic low back pain. It is therefore of paramount importance that compliance with such treatment be assessed to allow for readjustments, as well as drug treatment. No gold standard6-7 measured patient adherence to exercise programs until the creation of the EARS in 2016 by E.Godfrey and his team (Exercise Adherence Rating Scale, literally "joining physical exercise programs")

EARS is a reliable and validated psychometric assessment questionnaire that assesses adherence to prescribed physical exercise in chronic low back pain.

primary_purpose: Screening

ReferenceCitation: Waddell G. 1987 Volvo award in clinical sciences. A new clinical model for the treatment of low-back pain. Spine (Phila Pa 1976). 1987 Sep;12(7):632-44. Review.

ReferenceCitation: Beinart NA, Goodchild CE, Weinman JA, Ayis S, Godfrey EL. Individual and intervention-related factors associated with adherence to home exercise in chronic low back pain: a systematic review. Spine J. 2013 Dec;13(12):1940-50. doi: 10.1016/j.spinee.2013.08.027. Epub 2013 Oct 26. Review.

ReferenceCitation: Bocéréan C, Dupret E. A validation study of the Hospital Anxiety and Depression Scale (HADS) in a large sample of French employees. BMC Psychiatry. 2014 Dec 16;14:354. doi: 10.1186/s12888-014-0354-0.

ReferenceCitation: Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. Review.

ReferenceCitation: Hall AM, Kamper SJ, Hernon M, Hughes K, Kelly G, Lonsdale C, Hurley DA, Ostelo R. Measurement tools for adherence to non-pharmacologic self-management treatment for chronic musculoskeletal conditions: a systematic review. Arch Phys Med Rehabil. 2015 Mar;96(3):552-62. doi: 10.1016/j.apmr.2014.07.405. Epub 2014 Aug 6. Review.

location_facility:
Hôpital COCHIN
CHU de Clermont-Ferrand
CHU de nîmes
CHU de Lille
CHU de Montpellier


title: Multicentric Evaluation of the True Negative Predictive Value of Multiparametric MRI for the Detection of Prostate Cancer Using Cystoprostatectomy Specimen as Reference

summary: To evaluate the negative predictive value of mpMRI in the detection of prostate cancer using cystoprostatectomy specimen as the reference

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Moldovan PC, Van den Broeck T, Sylvester R, Marconi L, Bellmunt J, van den Bergh RCN, Bolla M, Briers E, Cumberbatch MG, Fossati N, Gross T, Henry AM, Joniau S, van der Kwast TH, Matveev VB, van der Poel HG, De Santis M, Schoots IG, Wiegel T, Yuan CY, Cornford P, Mottet N, Lam TB, Rouvière O. What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. Eur Urol. 2017 Aug;72(2):250-266. doi: 10.1016/j.eururo.2017.02.026. Epub 2017 Mar 21. Review.

ReferenceCitation: N. Mottet JB, E. Briers, R.C.N. van den Bergh, M. Bolla, N.J. van Casteren, P. Cornford, S. Culine, S. Joniau, T. Lam, M.D. Mason, V. Matveev, H. van der Poel, T.H. van der Kwast, O. Rouvière, T. Wiegel. Guidelines on prostate cancer. European Association of Urology Web site https://uroweborg/guideline/prostate-cancer/. Accessed May 17, 2016.

ReferenceCitation: Schoots IG, Petrides N, Giganti F, Bokhorst LP, Rannikko A, Klotz L, Villers A, Hugosson J, Moore CM. Magnetic resonance imaging in active surveillance of prostate cancer: a systematic review. Eur Urol. 2015 Apr;67(4):627-36. doi: 10.1016/j.eururo.2014.10.050. Epub 2014 Nov 15. Review.

ReferenceCitation: Le JD, Tan N, Shkolyar E, Lu DY, Kwan L, Marks LS, Huang J, Margolis DJ, Raman SS, Reiter RE. Multifocality and prostate cancer detection by multiparametric magnetic resonance imaging: correlation with whole-mount histopathology. Eur Urol. 2015 Mar;67(3):569-76. doi: 10.1016/j.eururo.2014.08.079. Epub 2014 Sep 23.

ReferenceCitation: Branger N, Maubon T, Traumann M, Thomassin-Piana J, Brandone N, Taix S, Touzlian J, Brunelle S, Pignot G, Salem N, Gravis G, Walz J. Is negative multiparametric magnetic resonance imaging really able to exclude significant prostate cancer? The real-life experience. BJU Int. 2017 Mar;119(3):449-455. doi: 10.1111/bju.13657. Epub 2016 Oct 4.

ReferenceCitation: Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.

ReferenceCitation: Robertson NL, Hu Y, Ahmed HU, Freeman A, Barratt D, Emberton M. Prostate cancer risk inflation as a consequence of image-targeted biopsy of the prostate: a computer simulation study. Eur Urol. 2014 Mar;65(3):628-34. doi: 10.1016/j.eururo.2012.12.057. Epub 2013 Jan 3.

ReferenceCitation: Wetterauer C, Weibel M, Gsponer JR, Vlajnic T, Zellweger T, Bütikofer S, Müller G, Püschel H, Bachmann A, Gasser TC, Bubendorf L, Rentsch CA. Incidental prostate cancer prevalence at radical cystoprostatectomy--importance of the histopathological work-up. Virchows Arch. 2014 Dec;465(6):629-36. doi: 10.1007/s00428-014-1656-9. Epub 2014 Oct 1.

ReferenceCitation: Bains LJ, Studer UE, Froehlich JM, Giannarini G, Triantafyllou M, Fleischmann A, Thoeny HC. Diffusion-weighted magnetic resonance imaging detects significant prostate cancer with high probability. J Urol. 2014 Sep;192(3):737-42. doi: 10.1016/j.juro.2014.03.039. Epub 2014 Mar 15.

ReferenceCitation: Steinberg DM, Fine J, Chappell R. Sample size for positive and negative predictive value in diagnostic research using case-control designs. Biostatistics. 2009 Jan;10(1):94-105. doi: 10.1093/biostatistics/kxn018. Epub 2008 Jun 12.

ReferenceCitation: DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.

ipd_sharing: No

lead_sponsor: Institut Paoli-Calmettes

location_facility:
CHRU Hopital Edouard Herriot
Hopital Nord
Institut Paoli Calmettes
Chu Saint Etienne
Institut Mutualiste Montsouris

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: Evaluation of 64Cu-ATSM PET/CT in Predicting Neo Adjuvant Treatment Response in Locally Advanced Rectum Cancer

summary: This phase II trial is assessing how 64Cu-ATSM (64Cu-copper(II) diacetylbis(N4-methylthiosemicarbazone)) PET/CT scan could predict neo adjuvant treatment response in rectum cancer locally advanced

study_start_date_type: Actual

status: Recruiting

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility: Institut de Cancerologie de l'Ouest (ICO)

intervention_type: Drug

lead_sponsor_type: industriel


title: Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease

acronym: COATS-VEGF

summary:
Coats disease is a predominantly unilateral progressive retinal vascular disease, characterized by retinal telangiectasias with intra- or subretinal exudate deposits, which can lead to retinal detachment and one-sided blindness. Several treatment modalities are available and the choice of one of them depends on the stage of the disease and the habits of each center (laser photocoagulation, cryotherapy ...). VEGF (Vascular Endothelial Growth Factor) was found to be significantly elevated in the aqueous humor and subretinal fluid of patients with Coats disease. Several studies have shown the potential efficacy of intra-vitreous injections of anti-VEGF. But the results on their effectiveness have been evaluated only on small series of patients. Most published studies have analyzed their efficacy combined with another treatment, mainly laser photocoagulation. The true efficacy of anti-VEGF therapy as initial therapy, and then combined in Coats disease remains unknown. Currently, several centers are initiating first-line anti-VEGF injections, although no rigorous evaluation of this therapeutic strategy has been conducted.

The identification of the best treatment regimen will allow in the future the reduction of laser reprocessing and will ensure a better functional benefit in the affected patients.

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: Undecided

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Hôpital Universitaire Necker Enfants Malades, APHP

location_facility: Centre hospitalier René Dubos (Pontoise)

location_facility: Fondation Ophtalmologique A. de Rothschild


title: Preventive Use of COrticosteroids During the Post-Partum in Relapsing MS

acronym: COPP-MS

summary:
Multiple Sclerosis (MS) is most prevalent among women of childbearing age. The post-partum (PP) period is a critical phase in MS patients, during which a recrudescence of disease activity is expected. Different strategies have been assessed in the prevention of post-partum relapse. High dose methylprednisolone was evaluated in a case control study with historical controls but the positive results have not been confirmed.

In this study, the main objective will be to compare the risk of relapse in the 6 months PP period between patients treated systematically by high dose methylprednisolone after delivery compared to patients who didn't receive a systematic treatment.

The second objective will be focused on the comparison of the disease activity and disability progression in patients who have resumed early a Disease Modifying Drug (DMD) after delivery vs patients who haven't.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Other

enrollment_type: Actual

lead_sponsor: Rennes University Hospital

location_facility:
CHU Lyon
CHU Strasbourg
Hôpital LAENNEC
CHU Rennes
Hôpital Pasteur 2 - CHU Nice

status_simplified: Completed


title: Feasibility and Efficacy of a New Ovarian Stimulation Regimen With RANDom Start, Use of Corifollitropin Alpha and Progestin Protocol for Oocyte donorS

acronym: RANDOS

summary: Oocyte donation is a cumbersome and demanding procedure, involving an injectable hormonal treatment for an average duration of 12 days, according to the protocols, 1 to several daily injections. The objective of this study is to show that treatments can be simplified without reducing the number of oocytes that have been punctured, by blocking the luteinizing hormone (LH) surge by using oral progesterone and by limiting the number of injections of gonadotropins using corifollitropin alpha, regardless of the start date of the pacing protocol during a natural cycle.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
Clinique de la Sagesse
CHU Bondy
CHU Marseille
CHU Tenon
CHRU Lille


title: Phase Ib Study Evaluating the Safety and Efficacy of Intratumoral Agonistic Anti-CD40 (Selicrelumab) in Combination With Anti-PDL1 (Atezolizumab) in Patients With Refractory or Relapsed B Cell Lymphoma

summary: This is a multicenter, open, dose escalation phase Ib trial of intratumoral agonistic anti-CD40 Ab (Selicrelumab intratumoral every 3 weeks for 3 cycles) in combination with anti-PDL1 Ab (Atezolizumab 1200mg intravenous every 3 weeks) in patients with refractory or relapsed B cell lymphoma

status: Terminated

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

status_simplified: Unknown


title: Regional Anticoagulation of Dialysis Extra-corporeal Circuits With a Calcium-free Citrate-containing Dialysate : Efficiency and Tolerance

summary: Critically ill patients have a high risk of bleeding but also require prolonged intermittent dialysis. Thus, a heparin-free easy-to-use alternative type of anticoagulation within the dialysis circuit is required. In a non-comparative study, heparin-free regional citrate anticoagulation of the dialysis circuit using a calcium-free citrate-containing dialysate, with calcium reinjected according to ionic dialysance, was considered as safe and efficient. The aim of this study is to confirm the superiority of this approach compared to a anticoagulation based on heparin-grafted membrane.

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU Toulouse
Pellegrin Hospital
Tenon Hospital
Montpellier Hospital
Nimes Hospital

intervention_type: Combination Product


title: Microvesicles and Monocytes to Predict Mortality of Patients With Cirrhosis

acronym: PROMICE

summary:
Chronic liver diseases related to viral hepatitis, metabolic syndrome or excessive alcohol consumption can evolve towards cirrhosis. Cirrhosis is responsible for 170 000 deaths per year in Europe. Initially asymptomatic and called "compensated" it can become "decompensated" with the developement of acute complications such as infections, ascites or variceal bleeding. The transition from compensated to decompensated cirrhosis is associated with a reduction in survival from 95 to 55% at 1 year.

The only curative treatment for cirrhosis is liver transplantation (LT). Liver transplants are allocated according to the severity of the patients. Despite a modest prognostic value (area under the ROC curve = 0.7 to predict the risk of death), graft allocation is based on the MELD (Model for End-Stage Liver Disease) score including INR, bilirubin and serum creatinine. In 2014, 11.5% of registered patients died on the liver transplant waiting list, illustrating the need for biomarkers that predict death and improve MELD-based prediction.

Microvesicles are membrane vesicles released in extracellular space during cell activation or apoptosis. Our team showed that circulating levels of hepatocyte microvesicles increase with the severity of cirrhosis and predict survival at 6 months independently of MELD score in a cohort of 242 patients with cirrhosis.

Type 1 interferons (IFN-1) are mediators of inflammation, which is excessively activated in cirrhosis. Our team has shown that a gene signature (IFN score) measured in the immune cells of 101 patients with cirrhosis is able to predict 6 month-survival independently of the MELD score.

Thus, the investigators hypothesize that a composite score combining the level of circulating hepatocyte microvesicles, the IFN score and the MELD score could improve the prediction of survival in patients with severe cirrhosis.

The aim of this study is to compare the prognostic performance for the cumulative incidence of death at 6 months of a composite score including MELD, hepatocyte microvesicle level and IFN score with that of the MELD score alone, in patients with Child B or C cirrhosis, considering liver transplantation as a competitive risk.

To address this question, peripheral blood from 335 patients with Child B or C cirrhosis will be obtained and hepatocyte microvesicle levels and IFN score will be measured using ELISA/filtration and Real Time-quantitative PCR.

time_perspective: Prospective

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Foch hospital
Avicenne Hospital
La Pitié Salpêtrière hospital
De La Fontaine hospital
Beaujon hospital


title: Chronic Urinary Retention in Elderly Living in Homes for the Aged : Benefits of Bladder Scan Screening

acronym: RUC EHPAD

summary: The goal of this cross-sectional, multicentric and descriptive epidemiological study is to assess the prevalence of chronic urinary retention (CUR) in elderly living in residential care for dependent elderly people in order to determine if there is an interest in offering them a bladder scan screening.

status: Unknown status

primary_purpose: Supportive Care

location_facility: EHPAD du Centre Local Hospitalier de Saint-Joseph

intervention_type: Diagnostic Test


type: Other Identifier

title: Multicenter, Diagnostic and Prospective Study to Differentiate Child Septic and Inflammatory Arthritis by Comparative Analysis

acronym: DIANE

summary: The purpose is to found new biomarker that differentiate septic arthritis and Juvenile Idiopathic Arthritis in children. Synovial liquid and blood samples with proteomic, MiRNA searching, multiplex cytokine analysis and cellular phenotyping, will be analysed. The results for each data will be compared in function of the disease to search discriminant markers. On behalf with this result specific pathways could be identified .

status: Active, not recruiting

lead_sponsor: University Hospital, Montpellier

location_facility: CHU Toulouse - Pediatric infectious diseases

location_facility: Hospices Civils de Lyon - pediatric rheumatology


title: Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur

acronym: PAAF

summary: Fracture of the upper extremity of the femur is a condition whose frequency increases with age. It is a serious disease, with multiple consequences such as a decrease in life expectancy, quality of life and patient autonomy. In this observational study, the investigators wish to evaluate the evolution of the autonomy of very elderly patients operated on for an upper extremity femur fracture as a function of early post-operative anemia.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CH Cholet
CHU Angers
CH Saint Malo
Centre Hospitalier Départemental Vendée
CH La Rochelle


title: CNV in AMD Analyzed by OCT Angiography Under IntravitreaL Eylea (COCTAEyl)

acronym: COCTAEyl

summary: The main objective of this study is to analyze a new noninvasive imaging examination, OCT angiography, in the evaluation of neovascular remodeling and early signs of recurrence of wet AMD undergoing treatment on OCTA and to correlate OCTA findings with SD-OCT findings.

location_facility: Centre Ophtalmologique d'Imagerie et de Laser,


title: Effect of a Neuromuscular Electrical Stimulation Program on Walking Capacity in Peripheral Artery Disease Patients: a Randomized Controlled Trial

acronym: ELECTROPAD

summary:
Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life.

Interventions designed to improve walking impairment may have a significant impact on the functional capacity in LEPAD patients. Lower extremity electrical stimulation is an older technique that relies on different types of electrical stimulations with different expected physiological effects on hemodynamics, skeletal muscle functions or pain pathway. The aim of the ELECTRO-PAD study is to assess the effect of a 12 weeks program of neuromuscular electrical stimulation (NMES) on the absolute walking distance (AWD) measured during a treadmill test in peripheral artery disease patients.

ReferenceType: derived

ReferenceCitation: Jéhannin P, Craughwell M, Omarjee L, Donnelly A, Jaquinandi V, Mahé G, Le Faucheur A. A systematic review of lower extremity electrical stimulation for treatment of walking impairment in peripheral artery disease. Vasc Med. 2020 Aug;25(4):354-363. doi: 10.1177/1358863X20902272. Epub 2020 Apr 17.

location_facility:
CHU Caen
CHU Angers
Hôpital de Rangueil
CHU Brest
CHU de Rennes

intervention_type: Other


title: National Retrospective Study to Characterize LOng REsponder Under EribuLINE (HALAVEN®) Metastatic Breast Cancer Patients

acronym: Loreline

summary:
There is currently no strict recommendations for the management of patients who have received at least one or two lines of anthracyclines-based chemotherapy and taxane therapy for advanced breast cancer. However, Halaven® can represent a therapeutic alternative at this stage of the disease.

Indeed, since march 2011, Halaven® has been granted Marketing Authorization (MA) for patients with metastatic or locally advanced breast cancer, whose disease has progressed after at least two lines of chemotherapy for advanced disease (3rd line). In these patients, the indication for marketing authorization specifies that the previous treatment must have included an anthracycline and a taxane except in patients who can not receive these treatments.

An extension of indication was obtained on 27/06/2014 with a marketing authorization obtained in the treatment of locally advanced or second-line metastatic breast cancer.

According to the Transparency Commission of the High Authority of Health (HAS dated September 23, 2015), Halaven® (Eribulin), administered as monotherapy, in the third line of treatment and beyond, represents a therapeutic option, because it brings an improvement of medical service rendered compared to Capecitabine (XELODA®) and Vinorelbine (NAVELBINE®).

In addition, Halaven® (Eribuline) administrated as monotherapy in second-line of treatment is an alternative to other monotherapies recommended for the treatment of locally advanced or metastatic relapsed breast cancer, such as Capecitabine (XELODA®). and Vinorelbine (NAVELBINE®). But, no improvement of medical service rendered has been reported in second line of treatment.

According to these results, it would be interesting to have additional data concerning the use of Halaven® (Eribulin), in the second and third lines, but also in the fourth line.

For this purpose, the investigators propose to perform a study in patients with metastatic breast cancer who have failed treatment after the first line and beyond.

In this study, the investigators will be particularly interested in "long-responder" patients, that is to say, in objective response or with stability for 6 months or more under Halaven®, in order to better characterize these patients. Patients must have been treated by Halaven between September 2011 and December 2016, to have a sufficient follow-up for the survival data of the patients.

time_perspective: Retrospective

lead_sponsor: Centre Jean Perrin

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Transcultural Validation of MSTS and TESS Questionnaire

acronym: MSTS-TESS

summary:
Reference treatment for soft tissue or bone sarcoma is the Monobloc resection surgery, with a margin of one to many millimeters removing the entire tumor leaving no cancer cells, associated or not with other treatments. Other musculoskeletal malignant tumors, some of them with secondary origins (metastases), are treated the same way. Patients with soft tissue and bone tumor could have heavy sequels of this surgery procedure, depending on the localization and size of the initial tumor. Those functional sequels are evaluated by specific questionnaires: the questionnaire TESS for upper limbs and TESS for lower limbs which are completed by the patient (depending on the localization of the tumor) and the questionnaire MSTS which is completed by the medical doctor.

Those English validated questionnaires are frequently used by French surgeons in standard practice as well as scientific research. The translations done have never been validated by an official methodology.

The aim of this trial is to validate the TESS and MSTS questionnaires linguistically, culturally (questions must be adapted for each target population: occidental adults and adolescents population, male and female population and adapted to the current era), and scientifically (repeatability).

The validation of those questionnaires will permit to have functional and reference questionnaires in French language which could be used for the follow up of operated patient in the context of the care and clinical research.

lead_sponsor: Nantes University Hospital

location_facility:
Tours University Hospital
Marseille University Hospital
Rennes University Hospital
Nantes University hospital
Nantes University Hospital


title: Impact of Behavioral Factors on Treatment Adherence in a Sample of Rheumatoid Arthritis Patients

acronym: MAINTAIN

summary: Rheumatoid arthritis (RA) care has been revolutionized in the last decade with the advent of biotherapies. Only 66% of treated patients are compliant. Nevertheless, studies analyzing the medication adherence in RA are rare. The aim of this study is thus to evaluate RA treatment adherence considering demographic data, vaccination coverage, feeding behavior and the use of e-health tools.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - service de rhumatologie

intervention_type: Behavioral


title: Circulating Tumor DNA for the Early Detection of HPV-positive Pelvic Cancer Relapses

acronym: CIRCA-HPV

summary: ctDNA detection in patients with previously treated, HPV-induced, stage II or III invasive pelvic cancer and who are currently in post-treatment follow-up.

lead_sponsor: Institut Curie

location_facility:
CHU Pontchaillou
Hôpital Tenon
CHU de Besançon
Institut Curie - Saint-Cloud
Institut Curie - Paris

intervention_type: Procedure


primary_purpose: Prevention

acronym: PREDIRESPUC

title: Value of Pharmacokinetic Assays (Vedolizumab and Anti-vedolizumab Antibody) in the Prediction of Induction and Maintenance Therapeutic Response in Ulcerative Colitis

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

type: EudraCT Number

source: euctr

location_facility:
Ch Lyon Sud
CHU Kremlin Bicêtre
CHU Saint-Etienne
Chu L'Archet
CHU Amiens

summary: Vedolizumab (VDZ) is a monoclonal antibody that binds to the heterodimer α4β7 integrin and which has shown its efficacy in Ulcerative Colitis (UC) by inducing and maintaining clinical response/remission. The French marketing authorization was obtained for Ulcerative Colitis in patients in failure with anti-Tumor Necrosis Factor (anti-TNF) agents. In the pivotal study, correlation between drug levels and clinical response during induction and maintenance therapy were reported. Moreover, in 3.7% of cases, anti-vedolizumab antibodies were reported during the time-course and 1% had samples that were persistently positive. Up to now, data on the pharmacologic VDZ parameters are scarce and the relationships as well as the predictive value of the measurement of VDZ concentrations and VDZ monoclonal antibodies (mAbs) during the induction and maintenance phases remains unknown. It could be of paramount interest to early identify UC patients under VDZ who will be responders to VDZ induction and to identify those who will achieve clinical remission under maintenance therapy with VDZ.


title: To Demonstrate the Ability of Abatacept in Comparison to Placebo to Obtain a Low Disease Activity [PMR-AS (CRP) Lower or Equal to 10] Without GCs (Prednisone or Prednisolone) at Week 12 in Early Onset PMR Patients.

acronym: ALORS

summary:
Polymyalgia rheumatic (PMR) is a frequent inflammatory disease. It affects the elderly, with peak incidences at the age of 70 to 80 years; an age >50 years or older, is considered a criterion for the diagnosis. Polymyalgia rheumatica occurs at a frequency that is 3 to 10 times that of giant-cell arteritis. Disease risk varies according to race and geographic region. The incidence is highest among whites in northern European populations (about 20 cases per 100,000 persons older than 50 years of age); it is lower in southern European populations (about 10 cases per 100,000).The diagnosis is based on established ACR/EULAR classification criteria.

Long term low-dose glucocorticoid (GCs) (prednisone or prednisolone started at 15 to 20 mg/day progressively tapered) is the mainstay of the treatment.

The activity of PMR is evaluated using the PMR-AS, a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment and pain assessment measured by the patient using VAS, and the C-reactive protein (CRP) level. The PMR-AS is considered as relevant to define relapse and remission but also to decide if treatment have to be decreased, unchanged or increased (PMR-AS < 10: decrease, PMR-AS > 17 increase to previous dosage, 10 ≤ PMR-AS ≤ 17: stable dose)..

Comorbidity in PMR are due to GCs and 30% of the patients underwent a relapse when tapering GCs. If the investigators able to start prednisone at a lower dosage (i.e. 8 mg then tapered for 3 to 4 months), the cumulative dosage of steroid would not have major side effects but it is not possible without new therapeutic agents.

The TENOR study (Tolerance and Efficacy of tocilizumab iN pOlymyalgia Rheumatica), a phase 2 study, demonstrated efficacy of tocilizumab as first line treatment in PMR without GCs and its ability to spare GCs. This was the first study demonstrating that a biologic may improve PMR without steroid, and that also showed that a short treatment by biologic followed by a low dose GCs therapy may be a new concept in the treatment of PMR.

Molecular studies in GCA and PMR suggest that dendritic cells initiate the pathogenic cascade and recruit T cells. Two major immune-response networks have been identified related to type 1 helper T-cell (Th1) and to helper T-cell (Th17). Abatacept is comprised of the ligand-binding domain of CTLA4 plus modified Fc domain derived from IgG1. By containing CTLA4, abatacept blocks the engagement of CD28 with its ligand, thereby inhibiting T cell activation. It has recently demonstrated its efficacy in Granulomatosis with polyangiitis (GPA) but also in giant cell arteritis (GCA). Due to its good safety profile in rheumatoid arthritis and its potential to modulate T cell activation and derived cytokines, abatacept is an attractive agent to investigate in patients with PMR.

In this randomized prospective placebo controlled study, the objective is to demonstrate the ability of abatacept to improve alone PMR and then to allow a steroid sparing effect after this induction treatment, in early onset PMR.

lead_sponsor: University Hospital, Brest

location_facility:
CHU Strasbourg
CH Le Mans
CH de Morlaix
CHRU de Brest
CH St-Malo


title: Identification of Biopsychosocial Factors Predictive of the Post-traumatic Stress Disorder Occurrence in Patients Admitted to the Emergencies After Trauma

acronym: ISSUE

summary:
After trauma or stress factor like death exposition, serious injuries or sexual violence, some patients may develop stress reaction characterized by the presence of various symptoms among different categories (reviviscence, negative humor, dissociates symptoms, occasion, hypervigilance). In the month following trauma, the investigators speak of acute stress reaction (ASR) when symptoms are present during at least three days. If symptoms are present one month after trauma, then it is a post-traumatic stress disorder (PTSD).

Among patients visiting emergency after latest trauma, quite a few is in acute stress reaction. However, this reaction is often incorrectly identified by healthcare team, due to lack of oriented medical examination, patients visiting about other complaints (pain, insomnia) and not expressing clearly the trauma context. Yet, it is know that acute stress reaction occurrence and existence of dissociate symptoms after trauma confrontation is considerably predictive of the eventual post-traumatic stress disorder occurrence.

The identification of risk population of post-traumatic stress disorder is not the subject of any particular structured procedure in emergency services while early care of these patients may allow limiting post-traumatic stress disorder occurrence and associate consequences. Previous works on the subject having exclusively targeted some trauma subgroups or some predictive factors subtypes, investigators propose here biopsychosocial global approach that can weight the impact of each parameters.

In this study, investigators aim at determining predictive biopsychosocial factors of the post-traumatic stress disorder occurrence at 3 months in patients visiting emergency after latest trauma (less than one month old) and identified as "high-risk" to develop post-traumatic stress disorder (moderate or high).

primary_purpose: Other

ReferenceCitation: Wafa MH, Viprey M, Magaud L, Haesebaert J, Leaune E, Poulet E, Bied C, Schott AM. Identification of biopSychoSocial factors predictive of post-traUmatic stress disorder in patients admitted to the Emergency department after a trauma (ISSUE): protocol for a multicenter prospective study. BMC Psychiatry. 2019 May 30;19(1):163. doi: 10.1186/s12888-019-2154-z.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Edouard Herriot - Urgences Psychiatrique et Médecine d'urgence

location_facility: CH St Joseph St Luc - Urgences Psychiatriques et Médecine d'urgence

location_facility: CHU St Etienne - Hôpital Nord - Urgences Psychiatriques

location_facility: CHU Clermont - Hôpital G Montpied - Urgences Psychiatriques et Médecine d'urgence

location_facility: Centre Hospitalier Lyon Sud - Urgences psychiatriques


title: Clinical and Genetic Analyzes of Age-related Macular Degeneration

acronym: COLDMLA

summary: The purpose of this collection is to search for susceptibility genes for age-related macular degeneration (AMD) alone or in combination with environmental factors and to look for genes that modulate the AMD phenotype (particularly the response to treatment).

location_facility: Centre ophtalmologique d'imagerie et de laser

intervention_type: Genetic


title: Biological Bank for Studies Related to Atrial Fibrillation and Stroke

acronym: BAFA

summary:
Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice. This arrhythmia is responsible for 15% of strokes and more than 30% of strokes on people over 65 years.

According to studies, 30 to 40% of isolated atrial fibrillations could be familial. Atrial fibrillation has significant genetic heterogeneity. About 40 genes have been identified as potentially involved. Studies have identified genes common to the risk of atrial fibrillation and stroke. Despite the pathophysiology of atrial fibrillation has been intensively and extensively studied for almost a century, there are still many questions. The pathophysiology is not sufficiently understood to allow finding more effective therapies. It is necessary to identify genetic determinants and thus potentially new pharmacological targets more adapted.

The establishment of a biological database will test hypotheses concerning the genetic origin and thromboembolic process of atrial fibrillation and associated stroke.

location_facility: Service neurologie Centre hospitalier Fleyriat

location_facility: Service d'urgences Neurovasculaires - service de neurologie vasculaire , Hôpital Pierre Wertheimer

location_facility: Service de médecine gériatrique Centre hospitalier Lyon Sud, Groupement hospitalier Sud

location_facility: Service de rythmologie, hôpital cardiologique Louis Pradel

intervention_type: Biological


title: Evaluation of the Efficacy of the Individually Adjusted Therapy Scale (ATI) on the Addiction Severity of Patients in Treatment for a Substance Use Disorder or a Gambling Disorder. A Multicenter Randomized Controlled Trial (AjusT)

acronym: AjusT

summary: The management of the craving is a key element in addiction treatment as the craving is linked to the probability of relapse. Several cues could induce the craving, some generic substance-induced cues or addictive behavior-related cues (e.g. gambling-related cues), and also some more subject-specific cues. The awareness of the craving intensity and its individual cues for each patient will allow the clinician to tailor a better treatment. The aim of this study is to evaluate the efficacy of a program based on an Individually Adjusted Therapy scale added to a treatment as usual for the treatment of addiction.

location_facility: Centre de Soin d'Accompagnement et de Prévention en Addictologie (CSAPA) BIZIA

location_facility: Centre Hospitalier Universitaire La Réunion


title: Prevention of Care-induced Pain in Elderly Persons With Cognitive Impairments and Living in EHPAD : Systematic Evaluation and Mediation With the PARO Robot.

acronym: PARODOL

summary:
Health care professionals lack tools to deal with acute pain in patients with moderate to severe dementia during daily nursing situations. Care-induced pain in institutionalized persons with cognitive impairments can cause anxiety and behavioral problems.The aim of this study is to demonstrate that a systematic identification of pain associated with the use of social robots such as the PARO robot may contribute to a better anticipation and management of care-induced pain. The investigators hypothesize that an individual use of the PARO robot would bring relaxation to the patient, a distraction regarding the aversive situation of care and, thus, it would prevent manifestations of acute pain in patients with dementia.

Secondary objectives of the study :

determine the effect of the use of PARO during painful cares on quality of life, medication of patients, and perceived workload of the health-care team.
examine socio-demographic and clinical responders' participants to the intervention, and,
identify essential elements regarding cost-effectiveness of a systematic evaluation of pain and a mediation with the PARO robot in care-induced pain

location_facility:
Résidence Mutualiste " Marie Lagrevol "
Résidence Mutualiste " La Cerisaie "
Hôpital Broca
Résidence Mutualiste " Les Tilleuls "
Résidence Mutualiste " L'adret "


title: Pharmacokinetics and Safety of Antimicrobial Agents Administered by Subcutaneous Route in Patients AGEd Over 65 Years

acronym: PhASAge

summary: Elderly people are more prone to develop infection with a poorer prognosis compared to young people. Physicians may encounter difficulties regarding antimicrobial agents administration route. In fact, poor venous access and behavioral disturbance are frequent issues. The subcutaneous (SC) route may be a safe alternative, but sparse data are available in the literature. The present study aims to describe Pharmacokinetics (PK) / Pharmacodynamics (PD) characteristics of antibiotics (amoxicillin/clavulanate, ceftriaxone and piperacillin/tazobactam) subcutaneous administration in patients aged over 65.

location_facility:
Hospital Métropole Savoie
CHU de Grenoble Alpes
CHU de Bordeaux
University Hospital, Poitiers
Hospices Civils de Lyon


title: Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study

acronym: ITS-PILOT

summary:
Ectopic soft tissue calcifications or ossifications can complicate the course of numerous diseases; most of them are rare or very rare. Even if the clinical, radiological and pathological presentation of ectopic calcifications and ossifications are different, the same hypotheses are discussed considering their hypothetical pathophysiology. Indeed, high calcium phosphate product, local cellular lesions and abnormal transdifferentiation of mesenchymal cells are regularly evoked when pathophysiology of such calcifications or ossifications are discussed. Apart from several case reports that have not been confirmed so far, no medical treatments are available, leading to significant pain and impairment of quality of life for patients. Therefore, only surgical treatment can be proposed when the volume or the consequences of these calcifications/ossifications become too important.

Sodium thiosulfate (STS) is currently used as a cyanide poisoning antagonist and a chemoprotectant against adverse effects of several chemotherapies such as Cisplatin. Numerous case reports and several studies have revealed the potential interest of STS in the treatment of uremic induced vascular or soft tissues calcifications. Recently, our group has developed an expertise in the use of STS for the treatment of ectopic soft tissue calcifications or ossifications. Considering these promising preliminary data, and their limits, we developed a strategy to treat soft tissue calcifications or ossifications based on a local administration of STS. The first results of this therapeutic strategy are highly promising and the local or systemic safety is satisfactory so far. These preliminary data also reported by others deserve to be confirmed in a prospective study.

We propose in this project to conduct a prospective open controlled phase II trial in order to assess the efficacy and the safety of intralesional administration of STS for the treatment of calcifications secondary to dermatomyositis or systemic sclerosis and ectopic ossifications secondary to pseudo-hypoparathyroidism 1a type (PHP1A/iPPSD2) (inactivating parathyroid hormone / parathyroid-hormone-related peptid (PTH/PTHrP) signalling disorder).

lead_sponsor: University Hospital, Limoges

location_facility:
ApHp - Hôpital Bicêtre
ApHp - hôpital Lariboisière
CHU de Limoges
CHU de MONTPELLIER
CHU de BORDEAUX


title: Detection of Chlamydia Trachomatis, Neisseria Gonorrhoeae and Mycoplasma Genitalium by Real-time Multiplex Polymerase Chain Reaction After Pooling Pharyngeal, Anorectal and Urinary Samples, in Men Who Have Sex With Men

acronym: ISTPOOL

summary: This study aims to compare the sensitivity of detecting Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium by real-time multiplex PCR in a pooled analysis (i.e. gathering pharyngeal, anorectal and urinary samples) versus the standard of care (where a real-time multiplex PCR is made in each of the three samples).

ReferenceCitation: Kacena KA, Quinn SB, Howell MR, Madico GE, Quinn TC, Gaydos CA. Pooling urine samples for ligase chain reaction screening for genital Chlamydia trachomatis infection in asymptomatic women. J Clin Microbiol. 1998 Feb;36(2):481-5.

ReferenceCitation: La Ruche G, Le Strat Y, Fromage M, Berçot B, Goubard A, de Barbeyrac B, Sednaoui P, Cambau E, Lot F. Incidence of gonococcal and chlamydial infections and coverage of two laboratory surveillance networks, France, 2012. Euro Surveill. 2015 Aug 13;20(32):6-15.

ReferenceCitation: Lewis JL, Lockary VM, Kobic S. Cost savings and increased efficiency using a stratified specimen pooling strategy for Chlamydia trachomatis and Neisseria gonorrhoeae. Sex Transm Dis. 2012 Jan;39(1):46-8. doi: 10.1097/OLQ.0b013e318231cd4a.

ReferenceCitation: Kacena KA, Quinn SB, Hartman SC, Quinn TC, Gaydos CA. Pooling of urine samples for screening for Neisseria gonorrhoeae by ligase chain reaction: accuracy and application. J Clin Microbiol. 1998 Dec;36(12):3624-8.

ReferenceCitation: Prazuck T, Lanotte P, Le Moal G, Hocqueloux L, Sunder S, Catroux M, Garcia M, Perfezou P, Gras G, Plouzeau C, Lévêque N, Beby-Defaux A. Pooling Rectal, Pharyngeal, and Urine Samples to Detect Neisseria gonorrhoeae, Chlamydia trachomatis, and Mycoplasma genitalium Using Multiplex Polymerase Chain Reaction Is as Effective as Single-Site Testing for Men Who Have Sex With Men. Open Forum Infect Dis. 2022 Oct 31;9(10):ofac496. doi: 10.1093/ofid/ofac496. eCollection 2022 Oct.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility:
CHR d'Orleans
CHU de Tours
CHU de Poitiers
CH Laennec
CH de Niort


title: Prediction of Adalimumab Treatment Response at 6 Months by Combinatorial Analysis of Serum Biomarkers in Biotherapy Naive Spondyloarthritis: Pilot Study

acronym: PRESHUM

summary:
The main objective of this trial is to search for biomarkers associated with the success of adalimumab treatment in order to generate an algorithm to predict the response to this treatment at 6 months in spondyloarthritis and to define its metrological properties on this cohort.

The algorithm will allow to better target patients who will have an important benefit/risk ratio for adalimumab treatment.

ReferenceCitation: Aaltonen KJ, Virkki LM, Malmivaara A, Konttinen YT, Nordström DC, Blom M. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One. 2012;7(1):e30275. doi: 10.1371/journal.pone.0030275. Epub 2012 Jan 17. Review.

ReferenceCitation: Baeten D, Kruithof E, Van den Bosch F, Van den Bossche N, Herssens A, Mielants H, De Keyser F, Veys EM. Systematic safety follow up in a cohort of 107 patients with spondyloarthropathy treated with infliximab: a new perspective on the role of host defence in the pathogenesis of the disease? Ann Rheum Dis. 2003 Sep;62(9):829-34.

ReferenceCitation: Baillet A, Trocmé C, Berthier S, Arlotto M, Grange L, Chenau J, Quétant S, Sève M, Berger F, Juvin R, Morel F, Gaudin P. Synovial fluid proteomic fingerprint: S100A8, S100A9 and S100A12 proteins discriminate rheumatoid arthritis from other inflammatory joint diseases. Rheumatology (Oxford). 2010 Apr;49(4):671-82. doi: 10.1093/rheumatology/kep452. Epub 2010 Jan 25.

ReferenceCitation: Brandt J, Khariouzov A, Listing J, Haibel H, Sörensen H, Grassnickel L, Rudwaleit M, Sieper J, Braun J. Six-month results of a double-blind, placebo-controlled trial of etanercept treatment in patients with active ankylosing spondylitis. Arthritis Rheum. 2003 Jun;48(6):1667-75.

ReferenceCitation: Braun J, de Keyser F, Brandt J, Mielants H, Sieper J, Veys E. New treatment options in spondyloarthropathies: increasing evidence for significant efficacy of anti-tumor necrosis factor therapy. Curr Opin Rheumatol. 2001 Jul;13(4):245-9. Review.

ReferenceCitation: Braun J, Brandt J, Listing J, Zink A, Alten R, Golder W, Gromnica-Ihle E, Kellner H, Krause A, Schneider M, Sörensen H, Zeidler H, Thriene W, Sieper J. Treatment of active ankylosing spondylitis with infliximab: a randomised controlled multicentre trial. Lancet. 2002 Apr 6;359(9313):1187-93.

ReferenceCitation: Braun J, Pham T, Sieper J, Davis J, van der Linden S, Dougados M, van der Heijde D; ASAS Working Group. International ASAS consensus statement for the use of anti-tumour necrosis factor agents in patients with ankylosing spondylitis. Ann Rheum Dis. 2003 Sep;62(9):817-24. Review.

ReferenceCitation: Braun J, Sieper J. Biological therapies in the spondyloarthritides--the current state. Rheumatology (Oxford). 2004 Sep;43(9):1072-84. Epub 2004 Jun 8. Review.

ReferenceCitation: Claudepierre P, Wendling D, Breban M, Goupillle P, Dougados M. Ankylosing spondylitis, spondyloarthropathy, spondyloarthritis, or spondylarthritis: what's in a name? Joint Bone Spine. 2012 Dec;79(6):534-5. doi: 10.1016/j.jbspin.2012.06.003. Epub 2012 Jul 28.

ReferenceCitation: Haibel H, Rudwaleit M, Brandt HC, Grozdanovic Z, Listing J, Kupper H, Braun J, Sieper J. Adalimumab reduces spinal symptoms in active ankylosing spondylitis: clinical and magnetic resonance imaging results of a fifty-two-week open-label trial. Arthritis Rheum. 2006 Feb;54(2):678-81.

ReferenceCitation: Hennigan S, Ackermann C, Kavanaugh A. Adalimumab in ankylosing spondylitis: an evidence-based review of its place in therapy. Core Evid. 2008 Jul 31;2(4):295-305.

ReferenceCitation: Kavanaugh A, Klareskog L, van der Heijde D, Li J, Freundlich B, Hooper M. Improvements in clinical response between 12 and 24 weeks in patients with rheumatoid arthritis on etanercept therapy with or without methotrexate. Ann Rheum Dis. 2008 Oct;67(10):1444-7. doi: 10.1136/ard.2008.094524. Epub 2008 Jun 5.

ReferenceCitation: Lyngberg KK, Harreby M, Bentzen H, Frost B, Danneskiold-Samsøe B. Elderly rheumatoid arthritis patients on steroid treatment tolerate physical training without an increase in disease activity. Arch Phys Med Rehabil. 1994 Nov;75(11):1189-95.

ReferenceCitation: Machado P, Landewé R, Lie E, Kvien TK, Braun J, Baker D, van der Heijde D; Assessment of SpondyloArthritis international Society. Ankylosing Spondylitis Disease Activity Score (ASDAS): defining cut-off values for disease activity states and improvement scores. Ann Rheum Dis. 2011 Jan;70(1):47-53. doi: 10.1136/ard.2010.138594. Epub 2010 Nov 10.

ReferenceCitation: Madland TM, Larsen A, Brun JG. S100 proteins calprotectin and S100A12 are related to radiographic changes rather than disease activity in psoriatic arthritis with low disease activity. J Rheumatol. 2007 Oct;34(10):2089-92. Epub 2007 Sep 1.

ReferenceCitation: McIntosh E. The cost of rheumatoid arthritis. Br J Rheumatol. 1996 Aug;35(8):781-90.

ReferenceCitation: Maksymowych WP. Biomarkers in axial spondyloarthritis. Curr Opin Rheumatol. 2015 Jul;27(4):343-8. doi: 10.1097/BOR.0000000000000180. Review.

ReferenceCitation: Maksymowych WP, Dougados M, van der Heijde D, Sieper J, Braun J, Citera G, Van den Bosch F, Logeart I, Wajdula J, Jones H, Marshall L, Bonin R, Pedersen R, Vlahos B, Kotak S, Bukowski JF. Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study. Ann Rheum Dis. 2016 Jul;75(7):1328-35. doi: 10.1136/annrheumdis-2015-207596. Epub 2015 Aug 12.

ReferenceCitation: Mounach A, El Maghraoui A. Efficacy and safety of adalimumab in ankylosing spondylitis. Open Access Rheumatol. 2014 Aug 13;6:83-90. eCollection 2014. Review.

ReferenceCitation: Pham T, van der Heijde D, Calin A, Khan MA, van der Linden S, Bellamy N, Dougados M; ASAS Working Group. Initiation of biological agents in patients with ankylosing spondylitis: results of a Delphi study by the ASAS Group. Ann Rheum Dis. 2003 Sep;62(9):812-6.

ReferenceCitation: Trocmé C, Gaudin P, Berthier S, Barro C, Zaoui P, Morel F. Human B lymphocytes synthesize the 92-kDa gelatinase, matrix metalloproteinase-9. J Biol Chem. 1998 Aug 7;273(32):20677-84.

ReferenceCitation: Trocmé C, Marotte H, Baillet A, Pallot-Prades B, Garin J, Grange L, Miossec P, Tebib J, Berger F, Nissen MJ, Juvin R, Morel F, Gaudin P. Apolipoprotein A-I and platelet factor 4 are biomarkers for infliximab response in rheumatoid arthritis. Ann Rheum Dis. 2009 Aug;68(8):1328-33. doi: 10.1136/ard.2008.093153. Epub 2008 Jul 29.

ReferenceCitation: Van Den Bosch F, Kruithof E, Baeten D, Herssens A, de Keyser F, Mielants H, Veys EM. Randomized double-blind comparison of chimeric monoclonal antibody to tumor necrosis factor alpha (infliximab) versus placebo in active spondylarthropathy. Arthritis Rheum. 2002 Mar;46(3):755-65.

ReferenceCitation: Wendling D, Claudepierre P, Lohse A, Toussirot E, Breban M. [Therapeutic use of anti-TNF-alpha agents in spondyloarthropathies]. Presse Med. 2003 Oct 4;32(32):1517-24. Review. French.

ReferenceCitation: Yelin E, Wanke LA. An assessment of the annual and long-term direct costs of rheumatoid arthritis: the impact of poor function and functional decline. Arthritis Rheum. 1999 Jun;42(6):1209-18.

lead_sponsor: University Hospital, Grenoble

location_facility:
CHRU de Clermont-Ferrand
CHU de Grenoble
CHU de Saint-Etienne
CH de Belfort
CHU de Besançon


title: Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model

acronym: Stress-PR

summary: Rheumatoid Arthritis (RA) is an inflammatory rheumatic disease that can lead to structural damage and handicap. The RA physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the RA mechanism, and improves the diagnosis and the treatment of the disease.

location_facility: CH de Libourne - service de rhumatologie

location_facility: CHU de Bordeaux - service de rhumatologie


title: Feasibility at Home of a Rehabilitation Program Before Thoracic Surgery, for Pulmonary Parenchyma Exeresis

acronym: FTR

summary: This study is a prospective observational study which aim to evaluate the feasibility of a total and systematic home respiratory rehabilitation training program in patients who will undergo thoracic surgery, and otherwise tend to define failure reasons.

ReferenceCitation: Catho H, Guigard S, Toffart AC, Frey G, Chollier T, Brichon PY, Roux JF, Sakhri L, Bertrand D, Aguirre C, Gorain S, Wuyam B, Arbib F, Borel JC. What are the barriers to the completion of a home-based rehabilitation programme for patients awaiting surgery for lung cancer: a prospective observational study. BMJ Open. 2021 Feb 10;11(2):e041907. doi: 10.1136/bmjopen-2020-041907.

location_facility: GROUPE HOSPITALIER MUTUALISTE INSTITUT de CANCEROLOGIE DANIEL HOLLARD


title: Quality of Tracheal Intubation in Prehospital Emergency Setting and Measurement of Risk Factors of Difficult Intubation in This Context

acronym: SMURIDS

summary: In prehospital emergency setting, tracheal intubation is a frequent procedure (8% of interventions). Its objective is to control and protect upper airways and to optimize ventilation and oxygenation in patients with life-threatening distress. Intubation is a technical procedure which is associated with few difficulties with, in rare cases, the impossibility to do it. There are specificities of the out-of-hospital emergency with some risk factors that have been recognized in this context as well as the impossibility of assessing predictive factors of difficult intubation linked to the patient. The objective of the investigators was to describe the quality of tracheal intubation in prehospital emergency setting.

location_facility: Aphp, Hopital Raymond Poincare - Samu-Smur 92

location_facility: CHU DE BORDEAUX- Hôpital PELLEGRIN - SAMU-SMUR 33


title: A Prospective Randomized Clinical Trial, in Open-label, Multicenter, Estimating the Impact of the Hypnosis on the Loss of Weight at Patients in Failure of Bariatric Surgery

acronym: BARIATHYPNOSE

summary: The therapeutic problem of obesity is weight control, a major difficulty, involving a significant change in eating behavior. A number of studies show that there are many factors of resistance to weight loss whether they are physiological, genetic, environmental pressure related, or psychological and behavioral. For some patients, the surgical approach seems the best alternative. Indeed, bariatric surgery is an effective therapeutic weapon in patients with morbid obesity. However, it has been shown that approximately 25% of patients are failing at two years of this surgery (Reinhold's index). Some of the failed subjects may benefit from surgical revision. As for the others, no intervention is currently proposed to them. Studies have shown that the psychological profile of patients who are candidates for bariatric surgery is predominantly impulsive, very anxious with a tendency to depression. The stress level of these patients would be important, and they would have low self-esteem. This study hypothesize that, in these patients, the establishment of hypnotherapeutic management associated with the usual dietary monitoring could modify eating habits thus promoting weight loss and an improvement in self-esteem , stress and anxiety compared to dietary monitoring alone.

location_facility: CHR Saint Pierre - maladies métaboliques


title: Clinical Impact of Concentration and Affinity of HLA-DQ Antibodies in Lung Transplantation - AFFIHLA-P

acronym: AFFIHLA-P

summary: The aim is to compare the quantitative parameters of de novo anti-HLA DQ Donor Specific Antibodies (DSA), determined at the time of their discovery by surface plasmon resonance (SPR), between recipients that developed a Chronic Lung Allograft Dysfunction (CLAD) for the 2 years following DSA apparition and those who did not. If concentration, kinetics and/or affinity parameters of anti-DQ DSA are associated with CLAD development, new, non-invasive prognostic biomarkers of humoral rejection in lung transplantation will be discovered .

location_facility:
Hôpital Foch
AP-HP Hôpital Bichat
CHU Bordeaux
Hôpital Européen Georges Pompidou
Hôpital Marie Lannelongue


title: A European, Multicenter, Randomized, Open-label, Phase II Trial Aiming to Assess the Clinical and Biological Activity of an Anti-PD-L1 (Atezolizumab) in Operable Localised Soft Tissue Sarcomas Patients to be Treated With Radiotherapy

acronym: RT-Immune

summary:
This multicentric, randomised, Phase II trial will use a pick-the-winner design in order to evaluate the clinical and biological activity of atezolizumab when combined with pre-operative or post-operative radiotherapy in STS patients.

Following Inform Consent Form (ICF) signature, eligible patients will be randomised (1:1:1) to receive:

Arm A: Radiotherapy followed by atezolizumab then surgery.
Arm B: Atezolizumab followed by surgery then radiotherapy.
Arm C: Radiotherapy then surgery followed by atezolizumab.

The sequence of the study treatments is different among the 3 study arms. However, the dose regimens will be the same:

Atezolizumab will be administered to all patients at the dose of 1200mg, by IV injection, for 2 cycles (Q3W).
Radiotherapy will be administered to all patients at the dose of 2Gy/day, 5 days per week, for a total of 5 weeks and 50Gy.
Surgery will be performed as per institutional practice.

Randomisation will be stratified according to histological subtypes as follows:

Group 1: Liposarcoma (LPS), Undifferentiated Pleomorphic Sarcoma (UPS), Leiomyosarcoma (LMS), myxofibrosarcoma, angiosarcoma versus Group 2: all translocation sarcoma except Ewing, rhabdomyosarcoma (RMS) and myxoid LPS.

lead_sponsor: Centre Leon Berard

location_facility:
Institut Bergonie
Centre Léon Bérard
Centre Oscar Lambret
Institut Gustave Roussy
Institut Claudius Regaud


title: Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer

acronym: EndoQOL

summary: Through this study, The investigator believe to evaluate the impact in terms of overall quality of life of adjuvant chemotherapy in patients with locally advanced endometrial cancer at a distance from their care

design_allocation: Non-Randomized

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Oscar Lambret
Institut Gustave Roussy
Centre Henri Becquerel
Centre Eugène Marquis
Centre François Baclesse


title: Validation of Completion of Items 18, 19 and 22 of the Motor Function Measure (MFM) on a Digital Tablet

acronym: MFM-tablet

summary:
Motor Function Measure (MFM) is a validated tool assessing the motor function of neuromuscular patients constituted of 32 items. Despite standardized Motor Function Measure (MFM) training sessions, there is still an inter-individual variability in the items' scoring procedure, depending for example on the subjectivity of the therapist.

Among the 32 items of the MFM, 3 currently require the use of a paper, and could be automated by using a digital tablet. It is the item 18 where the patient traces the edge of a Compact Disc, item 19 requiring to draw loops inside a frame and item 22 requiring to place a finger on each standardized cases. The reproducibility of these 3 items could be improved with the use of a digital tablet and the development of a software allowing to computerize the scoring procedure. The second interest is to implement directly the MFM data in the MFM base.

The hypothesis is that the difference of scoring of these 3 items between digital tablet versus paper completion is enough low to use indifferently each completion in patients with a neuromuscular disease.

location_facility: Centre de référence MNM adulte Lyon Hôpital de la Croix Rousse Bâtiment P

location_facility: Centre de référence MNM Adulte Saint Etienne CHU Hôpital Nord-service neurologie

location_facility: Service de Médecine Physique et de Réadaptation Pédiatrique Hôpital de Bellevue, CHU

location_facility: Centre de référence MNM Adulte Grenoble Consultation Maladies Neuromusculaires Adultes - CHU Michallon

location_facility: Service de Rééducation Fonctionnelle Pédiatrique - L'Escale (Aile A1) - Hôpital Femme Mère Enfant - GHE


title: Impact Study on Cerecare Compression Garments in the Treatment of Ehlers-Danlos Syndromes

summary:
EDS (Ehlers-Danlos syndromes) form a heterogeneous group of hereditary connective tissue pathologies, which present a characteristic triad: cutaneous hyperelasticity, articular hyperlaxity and connective tissue fragility.

The innumerable sprains and dislocations of all the joints require recurrent immobilizations and are responsible for a musculoskeletal handicap, chronic pains and a great fatigability, resounding on the quality of life of the patient.

The use of custom-made compression garments seems to provide relief from pain, especially nociceptive pain and in stabilizing joints by proprioceptive effect.

The SEDCARE study is an observational monocentric, non-comparative study. 76 patients will be followed in this study for 2 years during which they will wear compression custom-made garments (Cerecare®).The main objective of this study is to demonstrate the effectiveness of pressure garments Cerecare in the EDS, especially in terms of joint pain.

lead_sponsor: Cerecare

location_facility:
Dr Michot
Dr Benistan
Dr Pontier
SLB Pharma
Dr Enjalbert


title: Screening of Psychoactive Substances Use and Anxio-depressive Disorders in Consultation for HIV Pre-exposure Prophylaxis

acronym: PrEP

summary:
HIV pre-exposure prophylaxis (PrEP) with Truvada®, a combination of two antiretrovirals (tenofovir & emtricitabine) is a prevention strategy for HIV-negative people at high risk of acquiring HIV. PrEP has thus been integrated as a new tool to significantly reduce the risk of HIV infection, especially among men who have sex with men (MSM). Since its introduction, an increase in sexually transmitted infections (STIs) has been observed, particularly in relation to the use of psychoactive substances in a sexual context (Chemsex).

In this context, the description and evaluation of these practices seem necessary, as well as the impact on the risk of addiction and mental health.

location_facility:
CEGIDD
Hospital of Perpignan
UH NIMES
Uh Montpellier
Hospital of Alès


title: Intradiscal Gelified Ethanol Versus Intradiscal Steroid in Refractory Lumbar Discogenic Pain: a Randomized Single-blind Study

acronym: IDIS

summary:
DISCOGEL® is on the market since 2007. About 20,000 kits were sold to date (October 2017). The device re-obtained its CE mark in 2017.

A clinical evaluation was performed by bibliographic route in 2016. Clinical data on more than 600 patients treated by DISCOGEL® were analyzed. These data should be confirmed by monitoring on the long term, with a large cohort of patients, over a two-year follow-up period.

As part of the post-CE surveillance, the manufacturer GELSCOM is responsible of this "Post-Market Clinical Follow-up" (PMCF) study in accordance with Directive 93/42/EEC and MEDDEV guide 2.12/2, to assess the efficacy and the long-term safety of DISCOGEL®.

The study is comparative. The results will evaluate the performance and safety of the CE-marked medical device used in "real life", in comparison with a steroid infiltration, used according to its indication and to the current standards. It will include economic data. Patients and evaluators will be blinded. Both DISCOGEL® and HYDROCORTANCYL 2,5 POUR CENT are authorized products used according to their intended use.

This is an interventional, prospective, national, multi-center, comparative, randomized, single-blind (patient and evaluator) post-market clinical study. The primary objective is to compare the short-term efficacy profile of DISCOGEL® versus intradiscal steroid.

lead_sponsor: Gelscom SAS

location_facility:
Hospital St-Etienne
Hospital Pellegrin
Hospital SUD La Reunion
Hospital St-Dié-des-Vosges
Hospital Valence


title: Internet Gaming Disorder Prevalence of Teenager Psychiatric Inpatient of 4 Psychiatric Units of French Region Auvergne-Rhône-Alpes

acronym: IGDPD

summary:
The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) recently identified Internet gaming disorder as a new potential psychiatric disorder which need further research. Several studies showed the important prevalence of psychiatric disorders among patients suffering from internet gaming disorder. Investigators hypothesize that on an other side the prevalence of internet gaming disorder among patients suffering from psychiatric disorders shall be high but it has never been studied yet.

The main goal of this trial is to examine the prevalence of internet gaming disorder using the Internet Gaming Disorder Test-10 (IGDT-10) among inpatient aged from 12 to 17 of 4 psychiatric units of French region Auvergne-Rhône-Alpes.

Secondary goals will be to assess a parental version of the IGDT-10 (IGDT-10-P) and to compare the two versions.

IGDT-10 will be passed during 6 months to every inpatient and IGDT-10-P to their parents within the 21 first days of the hospitalisation.

location_facility: Service de psychiatrie adulte Hôpital Pierre Wertheimer-GHE

location_facility: Service de pédopsychiatrie - Unité H.Flavigny Centre hospitaliser Le Vinatier

location_facility: Psychopathologie du Développement Hôpital Femme Mère Enfant

location_facility: Service de pédopsychiatrie - Unité Adolescents ULYSSE - Centre hospitalier St Jean-de-Dieu

location_facility: Service de pédopsychiatrie Centre hospitalier Pierre Oudot


title: National, Single-arm Clinical Study on iDTECT™ Blood Performance to Identify Viral or Bacterial Pathogens in Febrile Neutropenic Patients With Suspected Infection

acronym: IDENTIFY

summary: Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia

lead_sponsor: Pathoquest

location_facility:
Hospital Robert Debré
Hospital Necker
Hospital Trousseau
Hosptial Saint Louis
Hospital Salpétrière


title: Family Therapy and Anorexia Nervosa : Which is the Best Approach? Family Therapy Multicenter Randomised Control Trial of Systemic Family Therapy Versus Multiple Family Therapy

acronym: THERAFAMBEST

summary: The aim of this study is to evaluate whether the implementation of Multiple Family Therapy (MFT) within a multi-disciplinary treatment program for Anorexia Nervosa (AN) in adolescence is at least as effective in terms of clinical Body Mass Index evolution as single Systemic Family Therapy (SyFT) after 12 months of treatment. We expect that these two techniques will not differ in terms of global efficacy, but that MFT could be more suitable for certain profiles who may be less responsive to SyFT.

ReferenceCitation: Carrot B, Duclos J, Barry C, Radon L, Maria AS, Kaganski I, Jeremic Z, Barton-Clegg V, Corcos M, Lasfar M, Gerardin P, Harf A, Moro MR, Blanchet C, Godart N. Multicenter randomized controlled trial on the comparison of multi-family therapy (MFT) and systemic single-family therapy (SFT) in young patients with anorexia nervosa: study protocol of the THERAFAMBEST study. Trials. 2019 Apr 30;20(1):249. doi: 10.1186/s13063-019-3347-y. Erratum in: Trials. 2020 Feb 18;21(1):196.

lead_sponsor: Institut Mutualiste Montsouris

location_facility: Clinique Médicale et Pédagogique Edouard RIST

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Maison de Solenn - Maison des Adolescents Cochin


type: Registry Identifier

title: Behavioral and Cognitive Therapies for Auditory Hallucination Management: Effectiveness and Analysis of Change Processes Involved With Hallucinations in a Population Suffering From Chronic Psychosis

acronym: AcceptVoice

summary: The present study wants to evaluate the efficacy of a short psychoeducational type group intervention and Cognitive behavioral therapy (CBT) 3rd wave on the severity of hallucinatory Acoustico-Verbal (HAV) symptomatology in patients with schizophrenia.

lead_sponsor: University Hospital, Toulouse

location_facility:
Ariège-Couserans Hospital
Sainte-Marie de Rodez Hospital
Lavaur Hospital
Gérard Marchand Hospital
Lannemezan Hospital


title: HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor

acronym: HYPNOS

summary:
The HYPNOS study is an acute feasibility study to validate a new device for automatic detection and treatment of sleep apnea syndrome. The system is known as the PASITHEA system and it will perform the following tasks:

Detect apneas and hypopneas in real time, based on physiological signals acquired with a cardiorespiratory holter (nasal air flow, heart rate and blood oxygen saturation (SaO2))
Upon detection of apnea or hypopnea events, trigger kinesthetic stimulation of mechanoreceptors of the skin close to the mastoid bone

The primary objective is to verify that the PASITHEA system is able to detect apneas and hypopneas reliably.

The main secondary objective of the study is to assess the effect of kinesthetic stimulation on reducing the number of sleep respiratory disorders.

Another objective of the study is to verify the safety of the PASITHEA system.

lead_sponsor: LivaNova

location_facility: Laboratoire du sommeil et d'EFCR; Hopital Michallon


title: Prospective Cohort of Patients With Pancreatitis Hospitalized in West French Intensive Care Units

summary: The purpose of this observational epidemiological study is to investigate the management and the complications associated with pancreatitis. Datas will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

status: Withdrawn

lead_sponsor: Nantes University Hospital

location_facility:
Poitiers University Hospital
Tours University Hospital
Rennes University Hospital
Angers University Hospital
Nantes University Hospital


title: A Prospective Cohort of Patients Hospitalized in West French Intensive Care Units for Peritonitis Surgically Treated

summary:
The purpose of this observational study is to investigate the management and the complications associated wtih surgically treated peritonitis.

Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.


title: Experience of the Father Following the Announcement of a First Pregnancy

summary: Experience of the father following the announcement of a first pregnancy Its context, immediate reactions and actions. Possible impact of this moment of life a few months or years later?


title: Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization

acronym: GOLILOR

summary: It is planned to enroll 80 UC patients who will require optimization of golimumab after secondary LOR. The review of the study protocol and its approval by an Independent Ethics Committee of the University of Saint Etienne are pending. All patients enrolled will give their written informed consent before being included. This study will be conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki, in compliance with the approved protocol, good clinical practice and applicable regulatory requirements. Patients will visit the investigator from screening visit to visit 6 at W-1, W0, W2, W4, W8, and at the end of the follow-up at wk 24. During their participation, patients will record clinical parameters required to calculate the partial Mayo score reported over 3 days prior to the visit and endoscopy at W0, W2 (optional) , W4, W8 (optional) and at the end of the follow-up to calculate total Mayo score.

location_facility:
CHU Lyon Sud
Chu Saint Etienne
CHU Amiens-Picardie
CHU Montpellier - St Eloi
CHU Nice


title: Retrospective Observational Study on the Safety of Immune Checkpoint Inhibitors in the Treatment of Advanced Melanoma and Lung Cancers in Patients With Pre-Existing Autoimmune Diseases

summary: The tolerance of immune checkpoint inhibitors is unknown in patients with pre-existing autoimmune conditions. This retrospective nation-wide study will assess their tolerance in patients with pre-existing autoimmune conditions who received immune checkpoint inhibitors for an advanced cancer in clinical practice.

location_facility:
CHU de DIJON
CH d'AIX
CHD Vendée
Ch Le Mans
CH de MACON


acronym: CHEMOIMMUNE

title: CHEMOIMMUNE - A Phase II Study Evaluating an Anti-PD1 Monoclonal Antibody (Pembrolizumab) in Lymphopenic Metastatic Breast Cancer Patients Treated With Metronomic Cyclophosphamide

location_facility: Institut de cancérologie Lucien Neuwirth

summary:
The investigators hypothesize that the administration of pembrolizumab combined to metronomic cyclophosphamide may be an interesting therapeutic option for female patients breast cancer with lymphopenia.

Include only patients with breast cancer with lymphopenia is based on the particularly poor prognosis of these patients. The approach suggested here is to deplete and active the immune response of these immunosuppressed patients. The combination of pembrolizumab and cyclophosphamide would provide a higher gain in anti-tumor response in these patients than in those without lymphopenia and in chemotherapy alone.

The investigators proposal is to conduct a multicentric, non-comparative, single arm, two-stage, Phase II trial in lymphopenic patients with metastatic breast cancer.

The study is divided in 2 parts:

a safety run-in Phase aiming to evaluate the safety of the combination therapy pembrolizumab + metronomic cyclophosphamide based on the occurrence of severe toxicities.
a two-stage Phase II aiming to evaluate the clinical activity of the combination therapy pembrolizumab + metronomic cyclophosphamide.

In both parts of the study, patients will receive cyclophosphamide (50 mg/day, daily, per os) and pembrolizumab (200 mg every 3 weeks, intravenously [IV]). The adverse events of the two drugs are well known.


title: Interventional Multicentre Pharmacokinetic Study of Adoport® (Tacrolimus) in Patients With de Novo Kidney Transplantation

acronym: IMPAKT

summary:
Tacrolimus is a calcineurin inhibitor widely used for the prevention of allograft rejection in solid organ and bone marrow transplantation. It is characterized by a narrow therapeutic index and large inter-individual pharmacokinetic variability. Adoport® is an immediate-release formulation of tacrolimus, to be administered twice daily. Because of a narrow therapeutic window and a better correlation between pre-dose level and effects than between dose and effect, therapeutic drug monitoring (TDM) based on trough whole blood tacrolimus concentrations is recommended for Adoport®. TDM helps to minimize the risk of acute rejection and the occurrence of adverse effects (mainly nephrotoxicity and, to a lesser extent, neurotoxicity).

As reported in a consensus document from a consortium of European experts on tacrolimus TDM, the interdose area-under-the curve (AUC0-12h) is expected to be the best marker of tacrolimus exposure. However, tacrolimus monitoring based on full AUC0-12h is difficult to set up in routine, due to clinical constraints and the necessity of multiple samples. Calculation of the AUC0-12h using Bayesian estimation and a limited sampling strategy, i.e. a few blood samples collected during the early phase post-dose would represent an elegant solution, as already done for other tacrolimus formulations.

Furthermore, the pharmacokinetics (PK) of tacrolimus is influenced by a single nucleotide polymorphism within intron 3 of cytochrome P450 3A5 (CYP3A5). Patients who carry at least one CYP3A5*1 allele are considered to be CYP3A5 expressors (about 12% of the Caucasian population, Hapmap project) and thus require a 1.5 to 2-fold higher starting dose than CYP3A5*3/*3 carriers to reach the predefined target exposure early after transplantation. Although this polymorphism showed no impact on the performance of the Bayesian estimators previously developed for other tacrolimus formulation, the patient status for CYP3A5*3 will be considered in this pharmacokinetic study as a potential covariate in, or confounding factor of, the PK model. Specifically, owing to a 12% frequency in the White European population, about 4 patients carriers of the CYP3A5*1 allele are expected in this study; the performance of the PK model and Bayesian estimator developed will be specifically evaluated in this subgroup.

location_facility:
Poitiers University Hospital
Amiens Picardie University Hospital
Tours University Hospital
CHU de ROUEN
Limoges University Hospital


title: Evaluation of a Personalized Normative Feedback Repeatedly Delivered Via a Mobile Application After a Brief Therapeutic Intervention on Alcohol-related Risks: a Multi Center Randomized Open Study in Young Adults Admitted to Emergency Room for Acute Alcohol Intoxication (AAI).

acronym: IFACAP

summary: BTI (Brief Therapeutic Intervention) motivates individuals admitted to ED (Emergency Department) for acute intoxication to take actions to prevent further alcohol-related issues. The present project aims at underpinning this intervention by actively involving patients in the monitoring of their alcohol-related risk following discharge. While several web-based preventive interventions towards alcohol already exist, the repeated delivering of PNF (Personalized Normative Feedback) using mobile technology after a BTI constitutes a novel approach to reduce alcohol-related harms. Investigators propose to test the effect of a mobile PNF following a BTI delivered by a psychologist during an ED visit for alcohol intoxication. The mobile PNF will be additionally delivered once a month in the 6-months period after discharge, and once every two months in the following 6-month period, via a smartphone application connected to a central server. The study will include 18-26 years old adults, as this population includes most active students and is often lost to follow-up after ED visits; and aims the reduction of heavy drinking occasions, as this issue account for most of alcohol-related ED visits in this population.

lead_sponsor: Rennes University Hospital

location_facility: Centre Hospitalier Universitaire Amiens Picardie

location_facility: Centre Hospitalier Universitaire Rennes Pontchaillou

location_facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital trousseau


title: TCF7L2 Polymorphisms Influence on Glycemic Control in ICU Patients With Organ Failure

summary: This study evaluates the link between genetic polymorphisms as r7903146, rs12255372 of TCF7L2 gene and the risk of developing hyperglycemia during Intensive care unit stay

ReferenceCitation: Ben Hamou A, Kipnis E, Elbaz A, Bignon A, Nseir S, Tamion F, Du Cheyron D, Jaillette E, Voisin B, Robriquet L, Vanbaelinghem C, Thellier D, Abi Rached H, Jannin A, Duhamel A, Behal H, Machuron F, Espiard S, Preiser JC, Preau S, Pattou F, Jourdain M. Association of transcription factor 7-like 2 gene (TCF7L2) polymorphisms with stress-related hyperglycaemia (SRH) in intensive care and resulting outcomes: The READIAB study. Diabetes Metab. 2020 Jun;46(3):243-247. doi: 10.1016/j.diabet.2019.05.001. Epub 2019 May 20.

lead_sponsor: University Hospital, Lille

location_facility:
CH Victor Provot
Hôpital Roger Salengro, CHRU de Lille
CHU Charles Nicolle
CHU Cote de Nâcre
CH Tourcoing


title: Randomised Controlled Trial With Two Parallel Arms Testing the Effect of L. Reuteri on Bowel Movements in Children Aged 6 Months to 4 Years

acronym: BIOWELL

summary: A randomized, multicenter, placebo-controlled, double blind study in two parallel groups testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938 compared to placebo in increasing the number of spontaneous bowel movements in infants and children with functional constipation.

ReferenceCitation: Jung C, Kalach N, Degas V, Jeridi Y, Bertrand V, Bellaiche M. Effect of L. reuteri on bowel movements in children aged 6 months to 4 years: A double-blind randomized controlled trial. Front Pediatr. 2022 Oct 26;10:997104. doi: 10.3389/fped.2022.997104. eCollection 2022.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Hôpital J. Monod - Pavillon Femme Mère Enfant - Le Havre

intervention_type: Dietary Supplement


title: InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS

acronym: OSIRIS

summary:
Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota imbalance, host-microbiota crosstalk dysfunction and inflammation.

As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly interested in patients with Bone and Joint Infections (BJI). These patients are treated with antibiotics having significant consequences on their intestinal flora, causing intestinal discomfort, which can be manifested by diarrhea.

MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI). The objective of this study is to follow patients with treated BJI in order to characterize intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota Transplantation (aFMT) intervention.

To do this, patients will be monitored according to the current CRIOAc recommendations, with the aim of taking biological samples from patients at the same time as scheduled visits, routine monitoring patients. Only one additional consultation will be carried out 15 days after stopping the antibiotics in order to better evaluate the dysbiosis evolution.

Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up consultations over a period of 6 months.

ipd_sharing: Yes

lead_sponsor: MaaT Pharma

location_facility:
HCL Croix-Rousse
CHU de Nantes
CHU Bordeaux
CH Tourcoing
GH Diaconesses-Croix Saint Simon


title: Evaluation of Efficacy and Safety of Rituximab in Association With Mycophenolate Mofetil Versus Mycophenolate Mofetil Alone in Patients With Interstitial Lung Diseases (ILD) Non-responders to a First-line Immunosuppressive Treatment

acronym: EvER-ILD

summary: The purpose of the study is to evaluate the efficacy on lung function 6 months after one course of rituximab (2 infusions) and mycophénolate mofétil (MMF) treatment compared to one course of placebo and 6 months of MMF treatment in a broad range of patients with Interstitial Lung Diseases (ILD) non-responders to a first line immunosuppressive treatment.

ReferenceCitation: Bejan-Angoulvant T, Naccache JM, Caille A, Borie R, Nunes H, Ferreira M, Cadranel J, Crestani B, Cottin V, Marchand-Adam S; OrphaLung. Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial. Respir Med Res. 2020 Nov;78:100770. doi: 10.1016/j.resmer.2020.100770. Epub 2020 May 23.

lead_sponsor: University Hospital, Tours

location_facility:
Chu Besancon
CHRU Tours
Chu Dijon
AP-HM Hôpital NORD
Chu Rennes


title: A Phase I Dose Escalation Trial Evaluating the Impact of an in Situ Immunization Strategy With Intra-Tumoral Injections of Pexa-Vec in Combination With Ipilimumab in Metastatic / Advanced Solid Tumors With Injectable Lesions.

acronym: ISI-JX

summary: The success of anti-CTLA4 therapy has inaugurated a paradigm shift in oncology where drugs target the immune system rather than cancer cells in order to stimulate the anti-tumor immune response. In situ immunization is a strategy where immunomodulatory products such as pathogens are injected into one tumor site in order to trigger a systemic anti-tumor immune response. Of importance, pre-clinical rationale has demonstrated that combination of anti-CTLA4 therapy together with intra-tumoral (IT) oncolytic virus can overcome primary resistance to systemic anti-CTLA4 therapy. Pexastimogene Devacirepvec (Pexa-Vec) is one of the new vaccinia oncolytic viruses genetically modified to express GM-CSF. This new and innovative oncolytic virotherapy should therefore synergize with anti-CTLA4 therapy via virus-induced tumor cell death & tumor-antigen release, GM-CSF-induced recruitment/maturation/activation of antigen presenting cells, and anti-CTLA4-induced Treg blockade/depletion. Intra-tumoral delivery of immunostimulating agents should, therefore, provide lower toxicity of mAb targeting immune checkpoints. Of note, IT injections of GM-CSF-encoding oncolytic viruses have already been shown to induce immune-mediated tumor responses on local (injected) and distant (not injected) tumor sites. In solid injectable refractory/relapsing metastatic tumors, we make the hypothesis that the addition of Pexa-Vec to IT ipilimumab (anti-CTLA4 Ab) will overcome primary/secondary resistance to standard therapy and/or immunotherapy with a better in situ tumor antigen specific T-cell priming. Our proposal is to conduct a 2-part Phase I clinical trial in order to define the feasibility, the safety and the anti-tumor effects of intra-tumoral injections of ipilimumab in combination with the oncolytic virus Pexa-Vec. Dose escalation step will define the MTD and RP2D of that in situ immunization strategy. Expansion part will assess the anti-tumor effect of the combination.

location_facility:
Institut Bergonie
Centre Léon Bérard
Institut Gustave Roussy
Hopital Saint Louis
Centre Hospitalier Lyon Sud


title: Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure

acronym: IOXSOR

summary: IOXSOR study's purpose to determine the frequency of non resolutive renal failure (estimated by the clearance of iohexol) at end of stay in ICU patients who have had acute renal failure episode.

lead_sponsor: University Hospital, Angers

location_facility:
Hospital
Hospital center
University Hospital


title: Outpatient Foley Catheter for Induction of Labor in Nulliparous for Prolonged Pregnancy

acronym: FOLOUT

summary: 15 to 20 % of nulliparous needs an induction at term. None study has evaluated Foley catheter induction at home versus expectative in this population

location_facility:
CHU de Caen
Ch Valenciennes
Hôpital Jeanne de Flandre - CHRU
CHU Rouen
CH Roubaix


title: Post-traumatic Stress Disorder Treatment Using Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy : a Two-arm Randomized Controlled Multicentric Study - T-TREAt

acronym: T-TREAt

summary:
Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that can develop after exposure to a terrifying event or ordeal in which there was the potential for or actual occurrence of grave physical harm. Traumatic events that may trigger PTSD include violent personal assaults, natural or human-caused disasters, accidents, and military combat. People with PTSD have persistent frightening thoughts and memories of their ordeal, may experience sleep problems, feel detached or numb, or be easily startled. Its lifetime prevalence is quite high, with 7-8% in various studies and 4% in french studies.

The current PTSD treatment usually involves antidepressants as serotonin-specific reuptake inhibitors (SSRIs) and Cognitive Behavioral Therapies, such as exposure therapy to trauma-linked elements (memories, feelings and thoughts) so the fear associated to the traumatic event can decrease. But the therapeutic response stays partial, even combining these treatments.

To improve the PTSD treatment efficiency, innovative approaches are being explored like new drugs or cerebral stimulation. This project aims to assess the efficacy of a less known but promising therapeutic strategy for PTSD : the use of transcranial Direct-Current Stimulation (tDCS) to enhance the trauma-focused therapy results.

location_facility:
CHU Nantes
CHU Tours
CHU Poitiers
CHU Angers
CHU Rennes


title: Phase I/II Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO®) in Renal Cell Carcinoma Patients With Bone Metastases.

acronym: EIFFEL

summary: This is a prospective, multicentre, open-label, phase I/II study to evaluate the maximum tolerated dose (MTD), and the most successful dose (MSD) of XOFIGO®, in renal cancer patients with metastases to bone, without (Group A) or with (Group B) visceral metastases.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility:
CHU Bordeaux (St. André)
Hopital Europeen Georges Pompidou
Hôpital Cochin
Institut Gustave Roussy
Centre François Baclesse


title: Analysis of Circulating Tumor Markers in the Blood

acronym: ALCINA

summary: Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.

ReferenceCitation: Sinoquet L, Jacot W, Gauthier L, Pouderoux S, Viala M, Cayrefourcq L, Quantin X, Alix-Panabières C. Programmed Cell Death Ligand 1-Expressing Circulating Tumor Cells: A New Prognostic Biomarker in Non-Small Cell Lung Cancer. Clin Chem. 2021 Nov 1;67(11):1503-1512. doi: 10.1093/clinchem/hvab131.

ReferenceCitation: Darrigues L, Pierga JY, Bernard-Tessier A, Bièche I, Silveira AB, Michel M, Loirat D, Cottu P, Cabel L, Dubot C, Geiss R, Ricci F, Vincent-Salomon A, Proudhon C, Bidard FC. Circulating tumor DNA as a dynamic biomarker of response to palbociclib and fulvestrant in metastatic breast cancer patients. Breast Cancer Res. 2021 Mar 6;23(1):31. doi: 10.1186/s13058-021-01411-0.

ReferenceCitation: Cabel L, Rosenblum D, Lerebours F, Brain E, Loirat D, Bergqvist M, Cottu P, Donnadieu A, Bethune A, Kiavue N, Rodrigues M, Pierga JY, Tanguy ML, Bidard FC. Plasma thymidine kinase 1 activity and outcome of ER+ HER2- metastatic breast cancer patients treated with palbociclib and endocrine therapy. Breast Cancer Res. 2020 Sep 14;22(1):98. doi: 10.1186/s13058-020-01334-2.

ReferenceCitation: Jacot W, Mazel M, Mollevi C, Pouderoux S, D'Hondt V, Cayrefourcq L, Bourgier C, Boissiere-Michot F, Berrabah F, Lopez-Crapez E, Bidard FC, Viala M, Maudelonde T, Guiu S, Alix-Panabières C. Clinical Correlations of Programmed Cell Death Ligand 1 Status in Liquid and Standard Biopsies in Breast Cancer. Clin Chem. 2020 Aug 1;66(8):1093-1101. doi: 10.1093/clinchem/hvaa121.

lead_sponsor: Institut Curie

location_facility:
Centre Georges François Leclerc
Institut du Cancer de Montpellier
Institut Curie (St Cloud hospital)
Institut Curie (Paris hospital)
Institut Mutualiste Montsouris


title: Prospective Study Evaluating the Medullary Thyroid Cancer Management's Care Using PET ( Positron Emission Tomography) F-DOPA in Patients With a High Level of Postoperative Residual Thyrocalcitonin

acronym: CMTpostopFDOPA

summary:
The aim of the trial is to study a radiating diagnosis agent used in post surgery when the biological assessment highlighted a residual disease.

This is an inter-regional multicentric, prospective study evaluating the benefit of PET F-DOPA imaging in involved node detection compared to standard imaging assessment in patient with medullary thyroid cancer.

The purpose of the study is to evaluate the impact and performance of a new PET / CT (computerized tomography ) tracer targeting dopamine receptor in patient with residual ganglionar biological disease after initial surgery of medullary thyroid cancer compared to standard imaging.

Obtained data will be compared to the "gold standard" based on :

nodes cytology when they could be punctured
histology when a new surgery will be recommended
surveillance when the 2 first cases will be not applicable (imaging monitoring, evolution of thyrocalcitonin)

lead_sponsor: Institut Claudius Regaud

location_facility:
CHU Timone
ICM Montpellier
CHU Haut-Lévêque
CHU Limoges
Institut Claudius Regaud


title: Impact of a Booklet-Question List on Cancer Patients or Their Families Seeking Prognostic Information During a Palliative Care Consultation

acronym: QUEPAL

summary: Prospective, randomized, multicentre phase III study to evaluate the level and type of information requested by patients or families during a palliative care consultation after they have been given the Booklet-Question List (BQL).

ReferenceCitation: Bouleuc C, Savignoni A, Chevrier M, Renault-Tessier E, Burnod A, Chvetzoff G, Poulain P, Copel L, Cottu P, Pierga JY, Brédart A, Dolbeault S. A Question Prompt List for Advanced Cancer Patients Promoting Advance Care Planning: A French Randomized Trial. J Pain Symptom Manage. 2021 Feb;61(2):331-341.e8. doi: 10.1016/j.jpainsymman.2020.07.026. Epub 2020 Jul 31.

location_facility:
Centre Alexis Vautrin
Polyclinique de l'Ormeau
Hopital René Huguenin
Institut Curie
Léon Berard


title: Does the Measure of the Plasma Tissue Factor Allow to Predict a Venous Thromboembolism Episode for Patients Presenting a Primitive Lung Cancer?

acronym: FT-KBP

summary: The aim of the study is to evaluate if the plasma activity of the tissue factor at the time of the diagnosis of a lung cancer, before any treatment, or after the treatment of induction (surgery or two first cures of chemotherapy), can be a predictive factor of venous thromboembolism disease in the year which follows the diagnosis, independently of the other parameters.

lead_sponsor: Hopital Foch

location_facility: Centre hospitalier intercommunal de Créteil


title: Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer

summary:
Increasing evidence suggests that immune responses might be a determining factor in lung cancer tumor progression.

The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response is required for their efficacy and highlight the critical role of antitumor T cell immunity. Recent progress on the fields of tumor immunology underlines the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.

In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators group have previously described novel promiscuous peptides (referred as UCP:Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.

By using UCP-based immuno-assay, pre-existing UCP-specific Th1 responses have been detected in the blood of lung cancer patients (Telocap01). The frequency and magnitude of this response were inversely correlate to the disease stage. Furthermore, UCP-specific responses were significantly found in patients with low PD1+ and TIM3+ T cells.

Then in TeloCap02 study, UCP specific Th1 immune responses will be evaluated in lung cancer before and after treatment (chemotherapy, immunotherapy).

ReferenceCitation: Godet Y, Fabre E, Dosset M, Lamuraglia M, Levionnois E, Ravel P, Benhamouda N, Cazes A, Le Pimpec-Barthes F, Gaugler B, Langlade-Demoyen P, Pivot X, Saas P, Maillère B, Tartour E, Borg C, Adotévi O. Analysis of spontaneous tumor-specific CD4 T-cell immunity in lung cancer using promiscuous HLA-DR telomerase-derived epitopes: potential synergistic effect with chemotherapy response. Clin Cancer Res. 2012 May 15;18(10):2943-53. doi: 10.1158/1078-0432.CCR-11-3185. Epub 2012 Mar 8.

ReferenceCitation: Godet Y, Dosset M, Borg C, Adotevi O. Is preexisting antitumor CD4 T cell response indispensable for the chemotherapy induced immune regression of cancer? Oncoimmunology. 2012 Dec 1;1(9):1617-1619.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Régional Universitaire de Besançon


title: Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies : Physicians and Patients Points of View and Interactions.

acronym: WHATELSE

summary: The decision to limit or withdraw specific therapies (DLWT) in patients with advanced cancer is a complex process that is always painful for patients, relatives and professionals. For more than 10 years, shared decision making has been more and more emphasized. However, few data in the literature rely on clinical research. In order to understand their difficulties and issues, this study explores the determinants and modalities of DLWT and analyses the feasibility of different methods for investigating this decision making process.

location_facility: Centre Hospitalier Universitaire St Antoine

location_facility: Centre de Luttre Contre le Cancer Alexis Vautrin

location_facility: Centre Hospitalier Universitaire de Besançon


title: Correlation Between Sorafenib Plasma Concentrations, Toxicity and Disease Control Rate in Patients Treated by Sorafenib for Hepatocellular Carcinoma

acronym: ACTES

summary: The aim of this pilot study is to correlate the sorafenib plasma concentration to observed toxicity and to the disease control rate in 100 patients undergoing a palliative treatment of hepatocellular carcinoma (HCC). If some correlations are observed, we will consider planning a larger interventional study to adjust sorafenib daily dose to plasma concentration.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Institut Bergonié
CHU de Toulouse
CHU de Bordeaux
CHU de Limoges
CHU de Montpellier


title: Multicenter Study on the Contribution of Surgical Treatment by ST2R Technique (Simultaneous Translation on Two Rods) in Scoliosis of the Children and Adolescents

summary:
Although practiced for many years, surgical correction of scoliosis is relatively subject published for idiopathic scoliosis and a few published for other types of scoliosis.

This study involves a creation of an observatory of patients undergoing scoliosis by ST2R reduction technique (Simultaneous Translation on Two Rods) associated with the PASS ® system.

The main objective is to analyze the three-dimensional correction of the deformity after intervention and its maintenance over time depending on the etiology of scoliosis.

This research is conducted in pediatric surgery services specialized in this technique.

Correcting radiographic parameters is directly related to the surgical procedure. The quality of life of patients is indirectly affected by the surgery. Secondary objectives are to analyze the surgical technique and to evaluate its impact on the quality of life of patients.

This study will firstly to have a better understanding in:

Scoliosis of the children and adolescents and their surgical treatment;
The impact of the surgical procedure by the ST2R technique on the three-dimensional correction, and the patient's quality of life; and secondly, better management of patients requiring surgery for scoliosis as well as a public health impact.

lead_sponsor: Fondation Lenval

location_facility: Hôpital mère-enfant pédiatrie, CHU Nantes