title: Endoscopic Detection of Small Bowel Dysplasia and Cancer in Patients With Jejuna or Ileal Crohn Disease : Prospective Study in a Cohort of High Risk Patients

acronym: DYDJI

summary:
Patients with Crohn's disease (CD) have an increased risk of small bowel adenocarcinoma (SBA). Long duration of CD is the main risk factor. SB dysplasia has been associated with SBA in 20% of cases, always described in diseased sites. The progression to neoplasia and natural history remains unknown but progression of inflammation to dysplasia and then to adenocarcinoma is suspected.

As for surveillance recommendations for colorectal carcinoma in long standing inflammatory colonic disease, endoscopic screening of SB could be proposed in CD patients with risk factors of SBA. No study can be found in literature.

The investigators propose a multicenter exploratory open study on prospective cohort of CD patients with high risk of dysplasia or cancer. The goal is evaluate the rate of dysplasia and adenocarcinoma detected by enteroscopy with biopsies in a high risk CD population

ReferenceCitation: Abrahams NA, Halverson A, Fazio VW, Rybicki LA, Goldblum JR. Adenocarcinoma of the small bowel: a study of 37 cases with emphasis on histologic prognostic factors. Dis Colon Rectum. 2002 Nov;45(11):1496-502.

ReferenceCitation: von Roon AC, Reese G, Teare J, Constantinides V, Darzi AW, Tekkis PP. The risk of cancer in patients with Crohn's disease. Dis Colon Rectum. 2007 Jun;50(6):839-55. Review.

ReferenceCitation: Jess T, Gamborg M, Matzen P, Munkholm P, Sørensen TI. Increased risk of intestinal cancer in Crohn's disease: a meta-analysis of population-based cohort studies. Am J Gastroenterol. 2005 Dec;100(12):2724-9. Review.

ReferenceCitation: Canavan C, Abrams KR, Mayberry J. Meta-analysis: colorectal and small bowel cancer risk in patients with Crohn's disease. Aliment Pharmacol Ther. 2006 Apr 15;23(8):1097-104.

ReferenceCitation: Palascak-Juif V, Bouvier AM, Cosnes J, Flourié B, Bouché O, Cadiot G, Lémann M, Bonaz B, Denet C, Marteau P, Gambiez L, Beaugerie L, Faivre J, Carbonnel F. Small bowel adenocarcinoma in patients with Crohn's disease compared with small bowel adenocarcinoma de novo. Inflamm Bowel Dis. 2005 Sep;11(9):828-32.

ReferenceCitation: Lashner BA. Risk factors for small bowel cancer in Crohn's disease. Dig Dis Sci. 1992 Aug;37(8):1179-84.

ReferenceCitation: Solem CA, Harmsen WS, Zinsmeister AR, Loftus EV Jr. Small intestinal adenocarcinoma in Crohn's disease: a case-control study. Inflamm Bowel Dis. 2004 Jan;10(1):32-5.

ReferenceCitation: Piton G, Cosnes J, Monnet E, Beaugerie L, Seksik P, Savoye G, Cadiot G, Flourie B, Capelle P, Marteau P, Lemann M, Colombel JF, Khouri E, Bonaz B, Carbonnel F. Risk factors associated with small bowel adenocarcinoma in Crohn's disease: a case-control study. Am J Gastroenterol. 2008 Jul;103(7):1730-6. doi: 10.1111/j.1572-0241.2008.01847.x. Epub 2008 Jun 28.

ReferenceCitation: Yamamoto T, Fazio VW, Tekkis PP. Safety and efficacy of strictureplasty for Crohn's disease: a systematic review and meta-analysis. Dis Colon Rectum. 2007 Nov;50(11):1968-86. Review.

ReferenceCitation: Greenstein AJ, Sachar D, Pucillo A, Kreel I, Geller S, Janowitz HD, Aufses A Jr. Cancer in Crohn's disease after diversionary surgery. A report of seven carcinomas occurring in excluded bowel. Am J Surg. 1978 Jan;135(1):86-90.

ReferenceCitation: Ribeiro MB, Greenstein AJ, Heimann TM, Yamazaki Y, Aufses AH Jr. Adenocarcinoma of the small intestine in Crohn's disease. Surg Gynecol Obstet. 1991 Nov;173(5):343-9.

ReferenceCitation: Watermeyer G, Locketz M, Govender D, Mall A. Crohn's disease-associated small bowel adenocarcinoma with pre-existing low-grade dysplasia: a case report. Am J Gastroenterol. 2007 Jul;102(7):1545-6.

ReferenceCitation: Riddell RH, Goldman H, Ransohoff DF, Appelman HD, Fenoglio CM, Haggitt RC, Ahren C, Correa P, Hamilton SR, Morson BC, et al. Dysplasia in inflammatory bowel disease: standardized classification with provisional clinical applications. Hum Pathol. 1983 Nov;14(11):931-68.

ReferenceCitation: Schlemper RJ, Riddell RH, Kato Y, Borchard F, Cooper HS, Dawsey SM, Dixon MF, Fenoglio-Preiser CM, Fléjou JF, Geboes K, Hattori T, Hirota T, Itabashi M, Iwafuchi M, Iwashita A, Kim YI, Kirchner T, Klimpfinger M, Koike M, Lauwers GY, Lewin KJ, Oberhuber G, Offner F, Price AB, Rubio CA, Shimizu M, Shimoda T, Sipponen P, Solcia E, Stolte M, Watanabe H, Yamabe H. The Vienna classification of gastrointestinal epithelial neoplasia. Gut. 2000 Aug;47(2):251-5.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Chu Amiens
Chu Besancon
Chu Nancy
Hopital Beaujon
Hopital Haut Leveque
CHU NICE
CHU LYON
Chu Saint Etienne
Chu Rouen
Chru Lille
Chu Tours
Hopital Saint Louis
Chu Toulouse
Institut Mutualiste Montsouris (Imm)
Hopital Bicetre


title: Ovarian Reserve and Semen Parameters Evolution During Adjuvant Therapy in Melanoma

acronym: MELpreserv

summary:
Prospective multicentric study including women aged 18 to 35 and men aged 18 to 45 during their visit to centers for the study and storage of human sperm and eggs (CECOS). Subjects will be included before adjuvant treatment initiation (T0) and immediately after treatment (approximately 1 year after initiation, T1), and, in late post treatment (1 year after treatment cessation, T2).

Expected results: This study will evaluate the evolution of AMH, AFC, and semen parameters in our cohort of melanoma patients treated with anti-PD-1 and targeted therapy in an adjuvant settings.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility:
Hôpital Saint-Joseph
CHU Montpellier
CHRU de Nîmes
CHU NICE L'archet
AP-HM

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Role of Monocytes Sub-populations in Thrombosis Associated With Myeloproliferative Neoplasms (MonSThr)

acronym: MonSThr

summary: Myeloproliferative neoplasms (MPN) are hematological malignancies associated with a major risk of thrombosis. Monocytes are hematopoietic cells with a central role in thrombosis. An activation of monocytes has been demonstrated in MPN patients. However, their study in MPN and their thrombotic complications has never been performed. In this study, we aim to evaluate the association between monocytes sub-populations and thrombotic risk in MPN patients.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux, Hématologie clinique et thérapie cellulaire

location_facility: CHU de Bordeaux, Médecine interne et immunologie clinique

location_facility: CHU de Bordeaux, Laboratoire Hématologie

location_facility: CHU de Bordeaux, Médecine Interne et maladies infectieuses

intervention_type: Biological


title: Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.

acronym: SURACAP

summary:
This study concern a prospective cohort pf patients with latent prostate cancer. We study the specific survival at 10 years of patients who accept an active control.Patients inclusion are realized in 2 stages:

patient with inclusion criteria (PSA < 10 ng/ml, clinical stage T1c or T2a, Gleason < or = 6) are registered if they accept a second prostate biopsy in a 3 months delay
after analyse of second biopsy in central laboratory and confirmation of latent prostate biopsy, patients are included if they accept active control Included patients will have 1 biopsy by years the first two years and then 1 biopsy each 2 years during 8 years.

If progression of cancer happens during the 10 years control, active control will be stopped and patient will be treated by surgery and chemotherapy.

status: Terminated

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Clinique Mutualiste Chirurgicale de la Loire

location_facility:
Eric LECHEVALLIER
RUFFION
P. ROSSI
RIGAUD Jérôme
Christophe AVANCES
Xavier REBILLARD
IRANI Jacques
Jean-Louis DAVIN
P Colloby
Clinique Mutualiste Chirurgicale
Henri BENSADOUN
SOULIE Michel
R Azzouzi
René GASCHIGNARD
SALOMON

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Unknown


title: Manageability and Safety Assessment of the SepraSpray Anti-adhesion Barrier in Abdominal Coelioscopic Surgery

acronym: C-MUST

summary: This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic).

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Berdah SV, Mariette C, Denet C, Panis Y, Laurent C, Cotte E, Huten N, Le Peillet Feuillet E, Duron JJ. A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery. Trials. 2014 Oct 27;15:413. doi: 10.1186/1745-6215-15-413.

lead_sponsor: Genzyme, a Sanofi Company

location_facility: Centre Hospitalier Intercommunal de Poissy Saint-German

intervention_type: Device

status_simplified: Completed


title: Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty

summary: The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices. The study will evaluate the outcome of Total Hip Arthroplasty using medical devices from SYMBOL range over a period of 10 years.

study_start_date_type: Actual

status: Recruiting

lead_sponsor: Dedienne Sante S.A.S.

location_facility: Hôpital d'Instruction des Armées Saint-Anne


type: Other Identifier

title: Effect of Tourniquet Abstention on Pain Reduction in Venous Sampling in the Elderly People : Randomized Trial

acronym: NO-GARROT

summary: This prospective study evaluates the effect of abstaining from tourniquets on pain reduction during the venous puncture of the elderly people.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Geriatric Department - Hospital René Dubos - Pontoise

location_facility: Geriatric Department - Intercommunal hospital center - Créteil

location_facility: Geriatric Department - Hospital Louis Mourier - Colombes


title: Efficacy of a Guiding Device for Mandibular Foramen Anesthesia, EZ-Block®, Compared With a Conventional "Freehand" Technique During Mandibular Wisdom Teeth Avulsion.

summary:
The success rates reported in the literature for the various truncal anesthesia techniques are extremely variable and have shown a lack of reproducibility of the techniques. The use of the EZ-BLOCK® guidance system would increase this success rate in a significant and reproducible way, as it is based on individualized anatomical foundations and therefore adapted to inter-patient variability.

In order to determine its effectiveness in clinical situations encountered in current practice, a comparative clinical study of the 2 techniques (freehand reference technique and using the EZ-BLOCK® system) is necessary.

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Haas DA. Alternative mandibular nerve block techniques: a review of the Gow-Gates and Akinosi-Vazirani closed-mouth mandibular nerve block techniques. J Am Dent Assoc. 2011 Sep;142 Suppl 3:8S-12S.

ReferenceCitation: Ravi Kiran BS, Kashyap VM, Uppada UK, Tiwari P, Mishra A, Sachdeva A. Comparison of Efficacy of Halstead, Vazirani Akinosi and Gow Gates Techniques for Mandibular Anesthesia. J Maxillofac Oral Surg. 2018 Dec;17(4):570-575. doi: 10.1007/s12663-018-1092-5. Epub 2018 Feb 26.

lead_sponsor: Elsan

location_facility: CHRU Nancy Service d'odontologie Brabois adultes

location_facility: Hôpitaux universitaires de Strasbourg Hôpital Civil Pôle de Médecine et chirurgie bucco-dentaires

location_facility: Service de médecine bucco-dentaire Hôpital BRetonneau - APHP

location_facility: Odontologie et traitement dentaire Pôle clinique des voies respiratoires Faculté de chirurgie de taire


title: A Prospective, Randomized, Multicenter, Comparative Study of the Efficacy of Imatinib Resumption Combined With Atezolizumab Versus Imatinib Resumption Alone in Patients With Unresectable Advanced Gastrointestinal Stromal Tumors (GIST) After Failure of Standard Treatments

acronym: ATEZOGIST

summary:
This trial is a prospective, randomized (1:1 ratio), multicenter, comparative and phase II study, conducted in patients with unresectable advanced gastrointestinal stromal tumors (GIST) after failure of imatinib (disease progression),sunitinib and regorafenib (either disease progression or intolerance)

In the first arm, patients will be treated with imatinib + atezolizumab (experimental arm), whereas in the second arm, patients will be treated with imatinib alone (control arm).

The comparison between this two arms will allow to compare whether or not atezolizumab and imatinib is efficient for disease control, in terms of Progression-Free Survival improvement.

lead_sponsor: Centre Leon Berard

location_facility:
Centre Léon Bérard
Hôpital de La Timone
Hôpital Robert Debré
Institut Gustave Roussy
ICANS CHRU de Strasbourg

intervention_type: Drug


ipd_sharing: Yes

primary_purpose: Prevention

title: A Multicentre Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine (580299) Co-administered With Boostrix Polio (dTpa-IPV) in Healthy Female Subjects Aged 10-18 Years

lead_sponsor: GlaxoSmithKline

source: euctr

ReferenceCitation: Schwarz T et al. Co-administration of AS04-adjuvanted HPV-16/18 cervical cancer vaccine with DTPA-IPV in 10-18 year old girls: Month 7 results from a randomized trial. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.

ReferenceCitation: Garcia-Sicilia J, Schwarz TF, Carmona A, Peters K, Malkin JE, Tran PM, Behre U, Iturbe EB, Catteau G, Thomas F, Dobbelaere K, Descamps D, Dubin G; HPV Vaccine Adolescent Study Investigators Network. Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine coadministered with combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine to girls and young women. J Adolesc Health. 2010 Feb;46(2):142-51. doi: 10.1016/j.jadohealth.2009.11.205.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country: Germany France Spain

summary:
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals' (580299)HPV-16/18 L1 AS04 vaccine (Cervarix TM) as compared to the administration of either vaccine alone.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


type: Registry Identifier

type: EudraCT Number

title: Phase II Randomized Study of First-Line Therapy Comprising Bevacizumab and Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil (FOLFIRI) Versus Bevacizumab and Irinotecan Hydrochloride and Capecitabine (XELIRI) in Patients With Unresectable Metastatic Colorectal Cancer [ACCORD]

summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with combination chemotherapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with bevacizumab in treating patients with colorectal cancer.

PURPOSE: This randomized phase II trial is studying bevacizumab to compare how well it works when given together with two different combination chemotherapy regimens as first-line therapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

ReferenceType: result

ReferenceCitation: Malka D, Boige V, Jacques N, Vimond N, Adenis A, Boucher E, Pierga JY, Conroy T, Chauffert B, François E, Guichard P, Galais MP, Cvitkovic F, Ducreux M, Farace F. Clinical value of circulating endothelial cell levels in metastatic colorectal cancer patients treated with first-line chemotherapy and bevacizumab. Ann Oncol. 2012 Apr;23(4):919-27. doi: 10.1093/annonc/mdr365. Epub 2011 Aug 8.

ReferenceCitation: Antoun S, Bayar MA, Dyevre V, Lanoy E, Smolenschi C, Ducreux M. No evidence for changes in skeletal muscle mass or weight during first-line chemotherapy for metastatic colorectal cancer. BMC Cancer. 2019 Aug 28;19(1):847. doi: 10.1186/s12885-019-6086-2.

lead_sponsor: UNICANCER

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes


title: Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes

summary: We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.

status: Unknown status

design_allocation: Non-Randomized

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Centre Hospitalier Universitaire de STRASBOURG


summary: The aim of this trial was to compare the safety and efficacy of courses of tobramycin and ceftazidime, administered intravenously as either thrice daily short infusions or 24 h continuous infusion, in cystic fibrosis patients with acute exacerbation of chronic pulmonary PA infection. In conventional treatment regimens, ceftazidime is administered in the form of thrice daily short infusions, but pharmacodynamic considerations suggest that continuous infusion could be more effective.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility: Assistance Publique des Hopitaux de Paris, Hopital Necker

location_facility: Assistance Publique des hopitaux de paris, Hopital Trousseau

location_facility: Assistance Publique des Hopitaux de Paris, Hopital Cochin

location_facility: Assistance Publique des Hopitaux de Paris, Hopital Robert Debré


title: Phase II Randomized Study Evaluting the Effect of Celecoxib as Maintenance Treatment of Stage IIIb Non-Small Cell Lung Cancer That Reponded or is Stable After Radiochemotherapy

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving celecoxib after radiation therapy and chemotherapy may kill any tumor cells that remain after radiation therapy and chemotherapy. Sometimes, after radiation therapy and chemotherapy, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.

PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to observation in treating patients who have undergone radiation therapy and chemotherapy for stage II or stage III non-small cell lung cancer.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Medical de Forcilles Hopital Prive

location_facility: Centre de Radiotherapie et Oncologie Saint-Faron

intervention_type: Radiation


title: Prospective, Multicentre, Open Study Evaluating the Performance and Stability of the AMIStem-P Femoral Stem

summary: This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis

lead_sponsor: Medacta International SA

location_facility:
Clinique de Saint Omer
Hôpital Castres
Hôpital Jacques-Puel
Nouvelle Clinique Bordeaux Tondu
Clinique d'Orange


title: Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids: a Prospective, Double-Blind, Placebo-Controlled Trial.

summary: Tracheal intubation is a frequent procedure in intensive care units (ICU). Post-extubation laryngeal edema is a frequent complication with potential morbidity and mortality, and may lead to urgent tracheal re-intubation. Corticosteroids have been proposed to reduce the incidence of post-extubation laryngeal edema. A few clinical studies have been conducted in adult ICU patients and have led to discrepant results. These discrepancies may be related to the time lag separating the administration of the corticosteroids and the planned extubation. Accordingly, we tested the hypothesis that pretreatment with corticosteroids initiated 12 hours before a planned extubation may efficiently prevent the occurrence of postextubation laryngeal edema in critically-ill adults who have been mechanically ventilated for more than 36 hours in the ICU.

ReferenceCitation: Kastanos N, Estopá Miró R, Marín Perez A, Xaubet Mir A, Agustí-Vidal A. Laryngotracheal injury due to endotracheal intubation: incidence, evolution, and predisposing factors. A prospective long-term study. Crit Care Med. 1983 May;11(5):362-7.

ReferenceCitation: Darmon JY, Rauss A, Dreyfuss D, Bleichner G, Elkharrat D, Schlemmer B, Tenaillon A, Brun-Buisson C, Huet Y. Evaluation of risk factors for laryngeal edema after tracheal extubation in adults and its prevention by dexamethasone. A placebo-controlled, double-blind, multicenter study. Anesthesiology. 1992 Aug;77(2):245-51.

ReferenceCitation: Ho LI, Harn HJ, Lien TC, Hu PY, Wang JH. Postextubation laryngeal edema in adults. Risk factor evaluation and prevention by hydrocortisone. Intensive Care Med. 1996 Sep;22(9):933-6.

ReferenceCitation: François B, Bellissant E, Gissot V, Desachy A, Normand S, Boulain T, Brenet O, Preux PM, Vignon P; Association des Réanimateurs du Centre-Ouest (ARCO). 12-h pretreatment with methylprednisolone versus placebo for prevention of postextubation laryngeal oedema: a randomised double-blind trial. Lancet. 2007 Mar 31;369(9567):1083-9.

lead_sponsor: University Hospital, Limoges

location_facility: Service de Réanimation - CH de Chateauroux

location_facility: Réanimation médicale et chirurgicale - Hôpital d'Angoulême

location_facility: Réanimation polyvalente - Hôpital d'Orléans

location_facility: Service de Réanimation - CH de Saint Nazaire

location_facility: Réanimation polyvalente - Hôpital de Cholet

location_facility: Réanimation Médicale - Hôpital Bretonneau

location_facility: Service de Réanimation Polyvalente - Hôpital Dupuytren


title: Explore the Associations of Behavioral Factors With Treatment Adherence in Axial Spondyloarthritis Patients Treated With Biotherapy

acronym: MAINTAIN II

summary: The management of chronic inflammatory rheumatism, including spondyloarthritis (SpA), has been revolutionized in recent decades with the arrival of biological therapy. The success of the current therapeutic strategy is also based on therapeutic compliance. If therapeutic adherence in rheumatoid arthritis patient (RA) is only 66%, it seems even worse in SpA. Few studies report quantitatively the adherence of SpA patients, as well as the predictive or associated factors. The objective of this study is to assess the patient adherence to biologics in patients with axial SpA (SpAax), and to investigate factors influencing this adherence, in particular the association with vaccination coverage, dietary behavior, and digital health tools.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU Clermont-Ferrand
CHU Montpellier
CHU Bordeaux
CHU Limoges
Chu Toulouse

intervention_type: Behavioral


title: Integrative Analysis of the Tumor Microenvironment and Optimization of the Immunotherapy Duration in Non-small Cell Lung Cancer Patients. OPTIMUNE-LUNG Study

acronym: OPTIMUNE-LUNG

summary: Non-comparative multicentric randomized study to assess long-term benefit of PD-1 inhibition in NSCLC patients who experienced a response between 6 and 12 months after initiation of ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy)

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonie
Clinique Tivoli Ducos
Clinique Marzet
Polyclinique Bordeaux Nord Aquitaine
Centre Hospitalier de la Côte Basque


title: Evaluation of Gingival Displacement With RACESTYPTINE Solution and RACEGEL: a Prospective, Comparative Randomized Clinical Trial.

acronym: RETRACT

summary:
The study design is a prospective, multi-center randomized, controlled, open label, 3-arm parallel group, post market clinical follow-up (PMCF) Clinical Trial.

The aim of the study is to collect clinical performance and safety data from RACEGEL and RACESTYPTINE Solution. Three gingival retraction techniques are being studied: RACESTYPTINE Solution with cord, RACEGEL with cord and RACEGEL without cord.

The study will demonstrate the expected performance of these 3 techniques in terms of sulcus opening, i.e. a lateral gingival displacement of at least 200 µm (state of the art) allowing the realization of pre-prosthetic impression with subgingivally margins. 90 subjects (teeth) requiring a dental restoration with subgingival margins for placement of a fixed prosthesis will be enrolled in 3 groups (30 in each group). For each participant, two dental impressions are performed: one impression before the gingival retraction and one impression immediately after the gingival retraction. Both impressions are scanned with 3D dental scanner and images are superimposed before analysis of tissue displacement.

lead_sponsor: Septodont

location_facility:
Cabinet dentaire - Médipole 35
Cabinet dentaire Magister
Cabinet dentaire
Cabinet dentaire Dr Rubin


title: Descriptive Factors of Intimate Partner Violence on Women Related to "Incapacité Totale de Travail" : Multicenter Prospective Study

acronym: SWIFT

summary:
Intimate partner violence is a real public health problem, and affects all socio-cultural backgrounds It is defined by behavior within an intimate relationship that causes physical, psychological or sexual harm or suffering to the people in that relationship.

Several risk factors exist such as young age, low level of education, exposing to violence during childhood, pregnancy or addictions.

ReferenceCitation: Leppäkoski T, Paavilainen E, Astedt-Kurki P. Experiences of emergency care by the women exposed to acute physical intimate partner violence from the Finnish perspective. Int Emerg Nurs. 2011 Jan;19(1):27-36. doi: 10.1016/j.ienj.2010.02.006. Epub 2010 May 20.

ReferenceCitation: Saberi E, Eather N, Pascoe S, McFadzean ML, Doran F, Hutchinson M. Ready, willing and able? A survey of clinicians' perceptions about domestic violence screening in a regional hospital emergency department. Australas Emerg Nurs J. 2017 May;20(2):82-86. doi: 10.1016/j.aenj.2017.02.001. Epub 2017 Mar 6.

ReferenceCitation: López-Ossorio JJ, González Álvarez JL, Buquerín Pascual S, García LF, Buela-Casal G. Risk factors related to intimate partner violence police recidivism in Spain. Int J Clin Health Psychol. 2017 May-Aug;17(2):107-119. doi: 10.1016/j.ijchp.2016.12.001. Epub 2017 Jan 31.

ReferenceCitation: Lyons VH, Kernic MA, Rowhani-Rahbar A, Holt VL, Carone M. Use of multiple failure models in injury epidemiology: a case study of arrest and intimate partner violence recidivism in Seattle, WA. Inj Epidemiol. 2019 Aug 12;6:36. doi: 10.1186/s40621-019-0215-x. eCollection 2019.

ReferenceCitation: Choi AW, Lo BC, Wong JY, Lo RT, Chau PC, Wong JK, Lau CL, Kam CW. Clinical Features of Heterosexual Intimate Partner Violence Victims With Escalating Injury Severity. J Interpers Violence. 2021 Sep;36(17-18):8585-8605. doi: 10.1177/0886260519850539. Epub 2019 May 29.

lead_sponsor: Centre Hospitalier Régional d'Orléans

location_facility: Centre Hospitalier Régional d'Orléans (UMJ)


title: Awakening of the Control of the Ankle Dorsiflexors in the Post Stroke Hemiplegic Subject to Improve Walking Activity and Social Participation: Experimental Interventional Study

acronym: WAKE

summary: This study is a multi-center, interventional, experimental, prospective, controlled and randomized study. We propose a reeducation protocol based on an early over-solicitation of the ankle dorsiflexor muscles to promote their "awakening", limit the loss of strength associated with the functional loss and thus allow to reach a more effective walking activity. This should encourage social participation following discharge from the hospital. The main objective is to evaluate the impact of this 6 weeks program on walking speed.

ReferenceCitation: Ferry B, Compagnat M, Yonneau J, Bensoussan L, Moucheboeuf G, Muller F, Laborde B, Jossart A, David R, Magne J, Marais L, Daviet JC. Awakening the control of the ankle dorsiflexors in the post-stroke hemiplegic subject to improve walking activity and social participation: the WAKE (Walking Ankle isoKinetic Exercise) randomised, controlled trial. Trials. 2022 Aug 16;23(1):661. doi: 10.1186/s13063-022-06545-w.

location_facility: University Institute of Rehabilitation Valmante Sud


title: Determination of Carboplatin's Optimal Plasmatic Exposure

summary: To determine Carboplatin's optimal exposures(optimal AUCs)and parameters they depend on.

lead_sponsor: Institut Claudius Regaud

location_facility:
Institut Bergonié
Centre Oscar Lambert
Centre René Gauducheau
CHRU Bretonneau
CHU A. Michallon
CHU de Toulouse Rangueil
Hopital Européen Georges Pompidou
Centre Antoine Lacassagne
Clinique Mathilde
CHU de la Timone
Centre Paul Papin
CHU de Nîmes
Institut Claudius Regaud
Clinique Pasteur
Centre Val d'Aurelle


title: Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination With Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy: a Randomized Phase II Study

acronym: RoboCUP

summary: We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy

primary_purpose: Diagnostic

lead_sponsor: Centre Francois Baclesse

location_facility:
CHU Rouen
Centre Oscar Lambret
CHU CAEN
Chru Lille
Centre François Baclesse


title: Impact of an Artificial Intelligence Platform on Inappropriate Medication Use in Older Adults

acronym: PING

summary: Polypharmacy in the older adults is common and promotes the risk of drug interactions. The hypothesis evoked is that a virtual platform with artificial intelligence applied to the health, and in particular to the good use of the drug, could bring aids to the doctors them of the prescription of drugs. The main objective of this study is to evaluate the impact of geriatric use of the Synapse platform on the frequency of inappropriate medication prescriptions (STOPP criteria) in discharge orders for patients 65 years of age or older hospitalized in geriatric department.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre Hospitalier de Libourne - Pôle Gériatrie


title: Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.

location_facility: Centre Hospital Universitaire Hop Huriez


title: Efficiency of Prevention Program Dedicated to Addictive Behaviors (PREVENTURE) of Vulnerable Teenagers

acronym: PREVADO

summary:
At the age of 17, in Brittany, 94.9% of adolescents have experimented alcohol consumption 78.1% within a month and 25.5% report repeated episodes of Intensive Punctual Alcohol. Among the potential explanatory factors of this worrying epidemiology, social and cultural factors induce a social valuation of alcohol consumption and drunkenness. There are also individual vulnerability factors, particularly important in adolescence between experimentation and the transition to regular use or even to alcohol use disorders. Despite the extent of the damage, there is currently little reliable data on effective primary prevention strategies for dealing with addictive behavior. Many prevention programs target age range in school settings, to delay or reduce use of psychoactive substances.

A meta-analysis on the impact of this prevention programs in school settings, concluded that most interventions are associated with no or little impact with respect to the goal of reducing psychoactive substances with teenagers.

Among existing programs, "PREVENTURE" has been evaluated in 5 trials with high-risk teenagers identified in schools settings, in different countries (Canada, Europe). The results show a clear and robust effect on reducing alcohol consumption. This program has not been tested outside the school setting and a recent review mention the need to make this program more accessible by targeting vulnerable groups and studying the impact of this program on this population.

The PREVADO study is a prospective, controlled, randomised, open-label study. After inclusion, the adolescent completes the questionnaire SURPS (Substance Use Risk Profile Scale).

The SURPS is self-report questionnaire that assesses four well-validated personality risk factors for substance misuse (Impulsivity, Sensation Seeking, Anxiety Sensitivity, and Hopelessness). There is a 23-item to which adolescents are asked to respond using a 4-point Likert scale ranging from "strongly agree" to "strongly disagree" : Hopelessness (7 items), Anxiety Sensitivity (5 items), Impulsivity (5 items), and Sensation Seeking (6 items).

Adolescents will be randomized into 2 groups (stratification on the 4 predominant risk personality types from the SURPS (Substance Use Risk Profile Scale) and on the recruitment modality) :

Intervention group : teenagers follow the "PREVENTURE" program and routine cares
Control group : teenagers follow routine cares

ReferenceCitation: Guillou-Landreat M, Tahmazov E, Benoit S, Grall-Bronnec M, Conrod P, Livet A, Nowak E, Le Reste J-. The efficacy of a targeted PREVENTION programme for addictive behaviour (PREVENTURE) among vulnerable ADOlescents in France - study procotol. BMC Public Health. 2021 Apr 23;21(1):783. doi: 10.1186/s12889-021-10795-9.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Catherine SIMON
Morgane GUILLOU - LANDREAT
Pascale ROZEC
Loik JOUSNI
Benoit SCHRECK


title: National Cohort of Colorectal Cancers With Microsatellite Instability

summary:
The three main pathways of colorectal carcinogenesis are chromosomal instability, microsatellite instability (MSI) (15% of colorectal cancers =CRCs) and CpG island methylator phenotype (CIMP). MSI CRCs are associated with a better prognosis after curative surgery than CRCs without microsatellite instability (MSS). In contrast, MSI CRCs do not appear to benefit from adjuvant 5-FU chemotherapy, unlike patients with MSS CRCs. Nevertheless, the benefit of adjuvant chemotherapy with FOLFOX seems to be retained. The identification of prognostic markers in this subgroup of patients is therefore essential to decide on adjuvant chemotherapy, the efficacy of which is currently debated in MSI CRC.

To date, there are very few data concerning metastatic MSI CRC. Metastatic forms are rare (about 5% of metastatic CRCs), but are thought to be associated with chemoresistance and poor prognosis. Nevertheless, data are very sparse and there are no data regarding the use of modern chemotherapies and targeted therapies in metastatic MSI CRC. Thus, it is important to characterize the chemosensitivity of metastatic forms.

Clinical predictors of recurrence after curative CRC surgery are known but have only been studied in MSI CRC retrospectively. Similarly, many molecular and immunohistochemical factors, prognostic or predictive of response to adjuvant chemotherapy, have been recently identified in CRC (KRAS, BRAF, TP53, PI3KCA mutations, CIMP phenotype, SMAD4, immune response...). Most of these markers have been studied in all CRCs, but not specifically in the MSI CRC subgroup. All these prognostic and/or predictive biomarkers need to be better characterized in a large cohort of MSI CRCs.

status: Active, not recruiting

ipd_sharing: Undecided

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Privé - Institut Du Cancer Avignon Provence


title: A Phase II Trial Evaluating Conformational Intensity Modulated Radiotherapy With Concomitant Nivolumab Followed by Nivolumab for Patients With Locally Advanced Non-small Cell Lung Cancer

acronym: AIRING

summary:
Radiotherapy (RT), at a total dose of 60-66 Gy over 6 weeks, combined with platinum-based chemotherapy, is the standard of care for stage III Non-Small Cell Lung Cancers (NSCLC) patients with unresectable or inoperable disease. However, the long-term outcomes are poor, with a 5-year overall survival (OS) rate of 15-35% for stage IIIA, and 5-10% for stage IIIB patients. The recent association of immunotherapy has been proven to improve Progression Free Survival (PFS) and OS for these patients and durvalumab consolidation following chemoradiotherapy (CT-RT) is now the new standard of care.

Compared to older technics (2Dimensions(D) and 3D-RT), intensity-modulated radiotherapy (IMRT) allows for improved organs-at-risk sparing, owing to the high dose conformation to the target volume, thus reducing toxicity rates.

In regard to the recent results of adjuvant immunotherapy, the benefits of concomitant chemotherapy with radiotherapy could be re-evaluated. With the changing landscape in the standard treatment of Local Advanced NSCLC (LA-NSCLC), the reduction in treatment-induced toxicity, while maintaining optimal tumor control, has become a priority, thereby warranting access to adjuvant immunotherapy for these patients. Due to the toxicity of the chemoradiotherapy, a large subset of patients may be unfit for the adjuvant immunotherapy. The use of immunotherapy concomitant to radiotherapy without chemotherapy may be the next step. Nevertheless, as immune cells are highly sensitive to conventional RT doses, the paradigm of the standard irradiation volumes should be reconsidered. In this context, the introduction of IMRT to spare lymphatic tissues and bone marrow deserves evaluation in prospective trials.

A strong body of evidence supports the combination of RT with immunotherapy such as a Programmed cells Death-1 (PD1) inhibitor. Radiation alone can modify the immune response in several ways to allow for synergistic effects when combined with immunotherapy.

The reduction in treatment-induced toxicity while maintaining optimal tumor control has become a priority, thereby warranting access to adjuvant immunotherapy for these patients. In this context, the introduction of IMRT to spare lymphatic tissues and bone marrow deserves evaluation in prospective trials.

The timing of administration of immunotherapy seems to be a major point. Previous data in mice showed that an improved survival benefit with concurrent anti-PD-Ligand1 (PD-L1) and RT versus sequential administration. Moreover, for sequential schedule, an improved survival outcome was found for patients receiving first dose of durvalumab within 14 days of last radiotherapy fraction compared to 14 days or greater.

Furthermore, immunotherapy combined with radiotherapy appears to be safe, without increase of the toxicity.

In summary, there is a strong rationale for testing this new paradigm of accelerated IMRT combined with concurrent and maintenance nivolumab for locally advanced non-small lung cancer, due to:

The unmet medical need for new Standard Of Care (SOC) better tolerated and " as " or " more " effective treatment than CT-RT
The need to decrease radiation-induced toxicity
The limit of CT-RT followed by durvalumab consolidation, leading to a high rate of recurrence within the 18 months (18-month PFS rate of 44.2%)
The strong rationale to combine RT and PD-1 inhibition

It is hypothesized this innovative concept to be safe in the context of this study for the following reasons:

The use of moderate accelerated intensity-modulated radiotherapy (H-IMRT) allows decreasing both the Overall Treatment Time (OTT) and the dose to the organs at risk
The decrease of the OTT (24 fractions instead of 33 fractions) combined with a decrease of the toxicity should represent a potential clinical benefit.

lead_sponsor: Center Eugene Marquis

location_facility: Centre de Lutte Contre le Cancer François Baclesse

location_facility: Centre de Lutte contre le Cancer Oscar Lambret

intervention_type: Combination Product


title: Phase II Study to Assess the Interest of a Sequential Treatment With Gemcitabine/Nab-paclitaxel (GEMBRAX) and Then FOLFIRINOX Followed by Stereotactic Magnetic Resonance-guided Adaptive Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

acronym: GABRINOX-ART

summary:
The aim of this study is to demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma.

The study will also demonstrate the feasibility of combining this intensified chemotherapy with MRI-guided stereotactic radiotherapy in non-progressive patients after the chemotherapy by Gabrinox regimen.

ReferenceCitation: Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.

ReferenceCitation: Ferlay J, Partensky C, Bray F. More deaths from pancreatic cancer than breast cancer in the EU by 2017. Acta Oncol. 2016 Sep - Oct;55(9-10):1158-1160. doi: 10.1080/0284186X.2016.1197419. Epub 2016 Aug 23.

ReferenceCitation: Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Choné L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.

ReferenceCitation: Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

ReferenceCitation: Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

ReferenceCitation: Suker M, Beumer BR, Sadot E, Marthey L, Faris JE, Mellon EA, El-Rayes BF, Wang-Gillam A, Lacy J, Hosein PJ, Moorcraft SY, Conroy T, Hohla F, Allen P, Taieb J, Hong TS, Shridhar R, Chau I, van Eijck CH, Koerkamp BG. FOLFIRINOX for locally advanced pancreatic cancer: a systematic review and patient-level meta-analysis. Lancet Oncol. 2016 Jun;17(6):801-810. doi: 10.1016/S1470-2045(16)00172-8. Epub 2016 May 6. Review.

ReferenceCitation: Philip PA, Lacy J, Portales F, Sobrero A, Pazo-Cid R, Manzano Mozo JL, Kim EJ, Dowden S, Zakari A, Borg C, Terrebonne E, Rivera F, Sastre J, Bathini V, López-Trabada D, Asselah J, Saif MW, Shiansong Li J, Ong TJ, Nydam T, Hammel P. Nab-paclitaxel plus gemcitabine in patients with locally advanced pancreatic cancer (LAPACT): a multicentre, open-label phase 2 study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):285-294. doi: 10.1016/S2468-1253(19)30327-9. Epub 2020 Jan 14.

ReferenceCitation: Kim YJ, Lee WJ, Woo SM, Kim TH, Han SS, Kim BH, Moon SH, Kim SS, Koh YH, Park SJ, Kim JY, Kim DY, Park JW. Comparison of capecitabine and 5-fluorouracil in chemoradiotherapy for locally advanced pancreatic cancer. Radiat Oncol. 2013 Jul 3;8:160. doi: 10.1186/1748-717X-8-160.

ReferenceCitation: Huang J, Robertson JM, Margolis J, Balaraman S, Gustafson G, Khilanani P, Nadeau L, Jury R, McIntosh B. Long-term results of full-dose gemcitabine with radiation therapy compared to 5-fluorouracil with radiation therapy for locally advanced pancreas cancer. Radiother Oncol. 2011 May;99(2):114-9. doi: 10.1016/j.radonc.2011.05.038. Epub 2011 May 27.

ReferenceCitation: Mukherjee S, Hurt CN, Bridgewater J, Falk S, Cummins S, Wasan H, Crosby T, Jephcott C, Roy R, Radhakrishna G, McDonald A, Ray R, Joseph G, Staffurth J, Abrams RA, Griffiths G, Maughan T. Gemcitabine-based or capecitabine-based chemoradiotherapy for locally advanced pancreatic cancer (SCALOP): a multicentre, randomised, phase 2 trial. Lancet Oncol. 2013 Apr;14(4):317-26. doi: 10.1016/S1470-2045(13)70021-4. Epub 2013 Mar 6.

ReferenceCitation: Yang YF, Cao XH, Bao CE, Wan X. Concurrent radiotherapy with oral fluoropyrimidine versus gemcitabine in locally advanced pancreatic cancer: a systematic review and meta-analysis. Onco Targets Ther. 2015 Nov 9;8:3315-22. doi: 10.2147/OTT.S91292. eCollection 2015.

ReferenceCitation: Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouché O, Shannon J, André T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.

ReferenceCitation: Petrelli F, Comito T, Ghidini A, Torri V, Scorsetti M, Barni S. Stereotactic Body Radiation Therapy for Locally Advanced Pancreatic Cancer: A Systematic Review and Pooled Analysis of 19 Trials. Int J Radiat Oncol Biol Phys. 2017 Feb 1;97(2):313-322. doi: 10.1016/j.ijrobp.2016.10.030. Epub 2016 Oct 24. Review.

ReferenceCitation: Reyngold M, Parikh P, Crane CH. Ablative radiation therapy for locally advanced pancreatic cancer: techniques and results. Radiat Oncol. 2019 Jun 6;14(1):95. doi: 10.1186/s13014-019-1309-x. Review.

ReferenceCitation: Crane CH, O'Reilly EM. Ablative Radiotherapy Doses for Locally Advanced: Pancreatic Cancer (LAPC). Cancer J. 2017 Nov/Dec;23(6):350-354. doi: 10.1097/PPO.0000000000000292. Review.

ReferenceCitation: Acharya S, Fischer-Valuck BW, Kashani R, Parikh P, Yang D, Zhao T, Green O, Wooten O, Li HH, Hu Y, Rodriguez V, Olsen L, Robinson C, Michalski J, Mutic S, Olsen J. Online Magnetic Resonance Image Guided Adaptive Radiation Therapy: First Clinical Applications. Int J Radiat Oncol Biol Phys. 2016 Feb 1;94(2):394-403. doi: 10.1016/j.ijrobp.2015.10.015. Epub 2015 Oct 17. Erratum in: Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):243.

ReferenceCitation: Fischer-Valuck BW, Henke L, Green O, Kashani R, Acharya S, Bradley JD, Robinson CG, Thomas M, Zoberi I, Thorstad W, Gay H, Huang J, Roach M, Rodriguez V, Santanam L, Li H, Li H, Contreras J, Mazur T, Hallahan D, Olsen JR, Parikh P, Mutic S, Michalski J. Two-and-a-half-year clinical experience with the world's first magnetic resonance image guided radiation therapy system. Adv Radiat Oncol. 2017 Jun 1;2(3):485-493. doi: 10.1016/j.adro.2017.05.006. eCollection 2017 Jul-Sep.

ReferenceCitation: Henke LE, Contreras JA, Green OL, Cai B, Kim H, Roach MC, Olsen JR, Fischer-Valuck B, Mullen DF, Kashani R, Thomas MA, Huang J, Zoberi I, Yang D, Rodriguez V, Bradley JD, Robinson CG, Parikh P, Mutic S, Michalski J. Magnetic Resonance Image-Guided Radiotherapy (MRIgRT): A 4.5-Year Clinical Experience. Clin Oncol (R Coll Radiol). 2018 Nov;30(11):720-727. doi: 10.1016/j.clon.2018.08.010. Epub 2018 Sep 7.

ReferenceCitation: Henke L, Kashani R, Robinson C, Curcuru A, DeWees T, Bradley J, Green O, Michalski J, Mutic S, Parikh P, Olsen J. Phase I trial of stereotactic MR-guided online adaptive radiation therapy (SMART) for the treatment of oligometastatic or unresectable primary malignancies of the abdomen. Radiother Oncol. 2018 Mar;126(3):519-526. doi: 10.1016/j.radonc.2017.11.032. Epub 2017 Dec 23.

ReferenceCitation: Boldrini L, Cusumano D, Cellini F, Azario L, Mattiucci GC, Valentini V. Online adaptive magnetic resonance guided radiotherapy for pancreatic cancer: state of the art, pearls and pitfalls. Radiat Oncol. 2019 Apr 29;14(1):71. doi: 10.1186/s13014-019-1275-3. Review.

ReferenceCitation: Bohoudi O, Bruynzeel AME, Meijerink MR, Senan S, Slotman BJ, Palacios MA, Lagerwaard FJ. Identification of patients with locally advanced pancreatic cancer benefitting from plan adaptation in MR-guided radiation therapy. Radiother Oncol. 2019 Mar;132:16-22. doi: 10.1016/j.radonc.2018.11.019. Epub 2018 Dec 20.

ReferenceCitation: El-Bared N, Portelance L, Spieler BO, Kwon D, Padgett KR, Brown KM, Mellon EA. Dosimetric Benefits and Practical Pitfalls of Daily Online Adaptive MRI-Guided Stereotactic Radiation Therapy for Pancreatic Cancer. Pract Radiat Oncol. 2019 Jan;9(1):e46-e54. doi: 10.1016/j.prro.2018.08.010. Epub 2018 Aug 25.

ReferenceCitation: Luterstein E, Cao M, Lamb J, Raldow AC, Low DA, Steinberg ML, Lee P. Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) for Locally Advanced Pancreatic Cancer: A Promising Approach. Cureus. 2018 Mar 14;10(3):e2324. doi: 10.7759/cureus.2324.

ReferenceCitation: Olberg S, Green O, Cai B, Yang D, Rodriguez V, Zhang H, Kim JS, Parikh PJ, Mutic S, Park JC. Optimization of treatment planning workflow and tumor coverage during daily adaptive magnetic resonance image guided radiation therapy (MR-IGRT) of pancreatic cancer. Radiat Oncol. 2018 Mar 24;13(1):51. doi: 10.1186/s13014-018-1000-7.

ReferenceCitation: Tyran M, Jiang N, Cao M, Raldow A, Lamb JM, Low D, Luterstein E, Steinberg ML, Lee P. Retrospective evaluation of decision-making for pancreatic stereotactic MR-guided adaptive radiotherapy. Radiother Oncol. 2018 Nov;129(2):319-325. doi: 10.1016/j.radonc.2018.08.009. Epub 2018 Aug 30.

ReferenceCitation: Rudra S, Jiang N, Rosenberg SA, Olsen JR, Roach MC, Wan L, Portelance L, Mellon EA, Bruynzeel A, Lagerwaard F, Bassetti MF, Parikh PJ, Lee PP. Using adaptive magnetic resonance image-guided radiation therapy for treatment of inoperable pancreatic cancer. Cancer Med. 2019 May;8(5):2123-2132. doi: 10.1002/cam4.2100. Epub 2019 Apr 1.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Institut régional du Cancer de Montpellier


title: Ezabenlimab (BI 754091) and mDCF (Docetaxel, Cisplatin and 5-fluorouracil) Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma. A Phase II Study

acronym: INTERACT-ION

summary:
Squamous cell carcinoma of the anus (SCCA) is a rare cancer, however its incidence is increasing worldwide. SCCA is mostly induced by human papillomavirus (HPV) infections (high-risk types such as HPV-16 and -18) and HPV-related oncoproteins (E6 and E7) are expressed in more than 90% of cases. T stage and N stage are recognized prognostic factors for local and/or distant recurrence in SCCA patients treated by CRT. In fact, ≥T3 or ≥N1 anal cancers are associated with as high as 50% disease recurrence rate at 2 years.

Since 1996 when concomitant radiotherapy and MMC (mytomicin C) and 5-FU-based chemotherapy demonstrated superiority to radiotherapy alone, no significant progress has been achieved in patients with locally advanced SCCA. Still, phase III study by James et al. reported in 2013 showed that prognosis of SCCA patients treated with this regimen can be improved probably due to a better tumor classification, more precise radiological methods, known as "Will Rogers phenomenon".

Based on the above, investigators have designed this phase II trial assessing the feasibility and efficacy of Ezabenlimab (BI 754091) and mDCF chemotherapy combination followed by:

standard chemoradiotherapy in case of low response to induction treatment (<30% by RECIST criteria) or
additional 2 cycles of mDCF and 1 cycle of Ezabenlimab (BI 754091) followed by hypofractionated radiotherapy in case of high response (≥ 30% by RECIST criteria)

in SCCA patients with high-risk locally advanced (stage III) disease.

In summary, the first innovative aspect of this research program is to provide a valuable proof of concept study evaluating the feasibility to combine radiotherapy, chemotherapies (docetaxel, cisplatin and 5-fluorouracil) and Ezabenlimab (BI 754091) in patients with stage III squamous cell anal carcinoma. INTERACT-ION study will provide evidence that Ezabenlimab (BI 754091) acts in synergy with mDCF to improve complete response rate, and both with hypofractionated radiotherapy to improve the disease-free survival enhancing TH1 and CD8 T cell immunity.

ReferenceCitation: Kim S, François E, André T, Samalin E, Jary M, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, De La Fouchardiere C, Smith D, Deberne M, Spehner L, Badet N, Adotevi O, Anota A, Meurisse A, Vernerey D, Taieb J, Vendrely V, Buecher B, Borg C. Docetaxel, cisplatin, and fluorouracil chemotherapy for metastatic or unresectable locally recurrent anal squamous cell carcinoma (Epitopes-HPV02): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2018 Aug;19(8):1094-1106. doi: 10.1016/S1470-2045(18)30321-8. Epub 2018 Jul 2.

ReferenceCitation: Kim S, Meurisse A, Spehner L, Stouvenot M, François E, Buecher B, André T, Samalin E, Jary M, Nguyen T, El Hajbi F, Baba-Hamed N, Pernot S, Kaminsky MC, Bouché O, Desrame J, Zoubir M, Ghiringhelli F, Parzy A, de la Fouchardiere C, Boulbair F, Lakkis Z, Klajer E, Jacquin M, Taieb J, Vendrely V, Vernerey D, Borg C. Pooled analysis of 115 patients from updated data of Epitopes-HPV01 and Epitopes-HPV02 studies in first-line advanced anal squamous cell carcinoma. Ther Adv Med Oncol. 2020 Dec 4;12:1758835920975356. doi: 10.1177/1758835920975356. eCollection 2020.

ReferenceCitation: Kim S, Boustani J, Vernerey D, Vendrely V, Evesque L, Francois E, Quero L, Ghiringhelli F, de la Fouchardière C, Dahan L, Bouché O, Chibaudel B, Hajbi FE, Vernet C, Rebucci-Peixoto M, Feuersinger A, Maritaz C, Borg C. Phase II INTERACT-ION study: ezabenlimab (BI 754091) and mDCF (docetaxel, cisplatin, and 5-fluorouracil) followed by chemoradiotherapy in patients with Stage III squamous cell anal carcinoma. Front Oncol. 2022 Aug 24;12:918499. doi: 10.3389/fonc.2022.918499. eCollection 2022.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: A Randomized, Placebo-controlled, Double-blinded, Phase II Study of Efficacy of Regorafenib as Maintenance Treatment in Patients With High Grade Bone Sarcomas at Diagnosis or Relapse and Without Complete Remission After Standard Treatment

acronym: REGOMAIN

summary:
This is a randomized, double-blinded, 2 arms study concerning patients with high-grade bone sarcoma (HGBS) without complete remission after standard treatment at diagnosis or first relapse.

In the first arm, patients will be treated with regorafenib + best supportive care (BSC) for a maximum of 12 months as maintenance therapy after standard line therapy completion, whereas in the second arm, patients will be treated with placebo + BSC (standard of care).

The comparison between this two arms will allow to determine whether or not regorafenib and BSC is efficient for disease control, in terms of Progression-Free Survival improvement.

lead_sponsor: Centre Leon Berard

location_facility:
Chu Besancon
Institut Bergonie
Institut Claudius Regaud
Ico Rene Gauducheau
Hôpital COCHIN
Icm Val D'Aurelle
ICANS
Centre Oscar Lambret
CHRU Hôpital Hautepierre
Institut Gustave Roussy
Chu Saint-Etienne
Hopital de La Timone
Centre Leon Berard
Centre Georges Francois Leclerc


title: Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial

acronym: DIPLOMA

summary:
Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail.

Study design: A pan-European, randomized controlled, multicenter, patient-blinded non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1. Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs ODP). A blinded adjudication committee will assess all endpoints.

Study population: Two groups of 129 patients (258 in total) with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.

Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)

Control: Open distal pancreatectomy

lead_sponsor: University Hospital, Montpellier

location_facility:
Centre Hospitalier Orléans
Hôpital Beaujon - APHP
CHU Saint Eloi - Montpellier
Institut Mutualiste Montsouris
Hôpital Paul Brousse


title: Intelligent Evaluation of Diabetic Retinopathy

acronym: EviRed

summary: Brief Summary: The main objective of EviRed project is to develop and validate a system assisting the ophthalmologist by improving prediction of evolution, and decision making during diabetic retinopathy (DR) follow-up. It will replace the current classification of diabetic retinopathy (DR) which provides an insufficient prediction precision. It will use modern available fundus imaging devices and artificial intelligence (AI) to properly integrate the amount of data they provide with other medical data of the patient. A cohort of 5000 diabetic patients will be recruited and followed for an average of 2 years in order to collect data to train and validate the new prediction system.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Clinique ophtalmologique du CHU de Nantes


title: Multicentric Prospective Cohort Study in Patients With Irreversible Biventricular Heart Failure to Assess the Efficacy and Safety of Carmat TAH, Its Clinical Utility and Cost, as a Bridge to Transplantation

acronym: EFICAS

summary: The objective of this clinical investigation is to evaluate the efficacy and the safety of the Carmat Total Artificial Heart for the treatment of refractory advanced heart failure in transplant eligible patients.

lead_sponsor: Carmat SA

location_facility: Centre Hospitalier Régional Universitaire


title: Functional and Respiratory Rehabilitation and Nutritional Care of COVID-19 Patients

summary: Following the acute phase of COVID, some patients may have sequelae, such as breathing difficulties or malnutrition. We hypothesize that a functional and respiratory rehabilitation program associated with personalized nutritional care will improve quality of life, physical performance and respiratory capacities and will decrease the prevalence of malnutrition among those patients.

lead_sponsor: Rennes University Hospital

location_facility:
Centre Hospitalier de Saint-Brieuc
CHU Rennes
Hôtel Dieu Paris
Centre Hospitalier de Cornouaille
Centre Hospitalier Bretagne Atlantique


title: Allodynia and Sensorial Hypersensitivity in Patients With Migraine: Validation of a Specific Questionnaire

acronym: Q-MIGAL

summary: Migraine is very frequent (15% of the general population). During attacks, many subjects with migraine have allodynia (pain induced by normally non-painful stimuli), photophobia (hypersensitivity to light), phonophobia (hypersensitivity to sound) or osmophobia (hypersensitivity to odours). The goal of the present study is to validate a new questionnaire made of 4 parts evaluating the presence of these 4 types of hypersensitivity, both during or between migraine attacks. It will allow to look for associations of these 4 symptoms and association of hypersensitivity with patients' or migraine's characteristics.

ReferenceCitation: Choi JY, Oh K, Kim BJ, Chung CS, Koh SB, Park KW. Usefulness of a photophobia questionnaire in patients with migraine. Cephalalgia. 2009 Sep;29(9):953-9. doi: 10.1111/j.1468-2982.2008.01822.x. Epub 2009 Feb 27.

ReferenceCitation: Lipton RB, Bigal ME, Ashina S, Burstein R, Silberstein S, Reed ML, Serrano D, Stewart WF; American Migraine Prevalence Prevention Advisory Group. Cutaneous allodynia in the migraine population. Ann Neurol. 2008 Feb;63(2):148-58.

ReferenceCitation: Khalfa S, Dubal S, Veuillet E, Perez-Diaz F, Jouvent R, Collet L. Psychometric normalization of a hyperacusis questionnaire. ORL J Otorhinolaryngol Relat Spec. 2002 Nov-Dec;64(6):436-42.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility: CHU de Clermont-Ferrand, Service de Neurologie

location_facility: CHU de Montpellier, Service de Neurologie

location_facility: Assistance Publique - Hôpitaux de Paris, CHU Lariboisière, Service de Neurologie

location_facility: CHU de Lyon, Hôpital Pierre Wertheimer, Service de neurologie fonctionelle et épileptologie

location_facility: CH Emile Roux Le Puy en Velay, Service de Neurologie

location_facility: CH d'Annecy, Centre d'Etude et de Traitement de la Douleur

location_facility: CHU de Nice, Département Evaluation et Traitement de la Douleur

location_facility: CHU de Clermont-Ferrand, Centre d'Etude et de Traitement de la Douleur

location_facility: Assistance Publique - Hôpitaux de Marseille, CHU La Timone, Centre d'Evaluation et Traitement de la Douleur


title: Étude Post-marché, Prospective, Multicentrique, Ouverte, d'évaluation de la prothèse Totale d'épaule inversée Medacta Shoulder System.

acronym: MSS

summary:
The goal of this study is to evaluate the performance of the Medacta Shoulder System total reverse shoulder prosthesis, at 2 years of follow up, in patients who required this prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy.

The main goal is to evaluate at 2 years post-operatively the shoulder function of patients. The secondary goals are to assess the rate of complications, the survival rate of Reverse Medacta Shoulder System, the positioning of the prosthesis,pthe behaviour of the bone in contact with the humeral stem, Patient satisfaction and evolution of shoulder function in patients at 3 months and 1 year post-surgery.

lead_sponsor: University Hospital, Tours

location_facility:
Chu Tours
Chu Angers
Clinique Mutualiste la Sagesse
Chu Rennes
Polyclinique santé atlantique


title: French Prospective Multicentre Non-Interventional Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice

acronym: DELTA

summary: The aim of the study is to explore how the individualized dosing regimen of REKOVELLE is used in routine clinical practice and to describe the effectiveness and safety of REKOVELLE under real-world conditions.

lead_sponsor: Ferring Pharmaceuticals

location_facility: Centre hospitalier de Lille-Hopital de Flandre

location_facility: Institut de Médecine de la Reproduction (there may be other sites in this country)

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Detection of Intracorporeal Bioresistant Nanocomposites Tracing Short- and Long-term Neurological Disorders in a Collective Fulguration

acronym: Fulgurnano

summary:
Objective: To demonstrate the presence of bioresistant intracorporeal carbon-based nanocomposites in subjects exposed to a fulguration, in the immediate aftermath of this fulguration and 24 months (+/- 6 months) after the accident, on blood and urine samples, then in comparison with blood and urine samples from 14 healthy subjects.

Hypothesis: Lightning discharge in the human body reveals the presence of multi-functional nanoparticles which are reassembled under the impact of the electric discharge into nanostructured films, filaments and aggregates; they consist of dispersed graphene-like nanoparticles embedded in an aliphatic cross-reticulated matrix. The high electrical conductivity of the nanoinclusions, their refractory properties and the cross-reticulation of the nanoassemblages explain their biorésistance.

The graphene-like multi-functional nanoparticles are assumed to trace a population of aerosols formed in the atmosphere by plasma discharge which is present in air, water and all natural resources. Their ability to undergo changes from folded nanosheets to confined ultra-fine nanoparticles allow them to be inhaled or absorbed by the human body, or to be ingested with food.

time_perspective: Retrospective

location_facility:
CH de Luneville
CH de SAINT-DIE-DES-VOSGES
CHRU de Nancy
CHRU Bradois
CH Henri Mondor

intervention_type: Diagnostic Test


title: Become of Patients Infected or Suspected of Being Infected by Covid-19 and Supported by the GHPSJ and the Establishments of the Paris Plaisance Hospital City

acronym: COVIDGHPSJCite

summary:
The ongoing Coronavirus (Covid-19) pandemic is causing a major global health crisis and is shaking up hospital organizations. To date, the recognized risk factors for severe forms of Covid-19 infection are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory pathologies, cardiovascular history (stroke or coronary artery disease), chronic respiratory conditions, high blood pressure, diabetes, and cancer. Covid-19 is manifested by a risk of acute respiratory distress syndrome requiring management by invasive ventilation. The lethality of this infection is around 4% in the current data.

Drastic precautionary measures for the transmission of the virus, as well as the provision of critical care beds by canceling any scheduled non-urgent intervention or consultation, have shaken up the hospital organization.

In this context, it is essential to have forward-looking data in real time to adjust the care offer and better understand the impact of Covid-19 on the patient populations treated.

time_perspective: Other

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility:
Groupe Hospitalier Paris Saint-Joseph
AURA Paris Plaisance
Fondation Sainte-Marie
Hôpital Marie Lannelongue
Hôpital Bellan


title: Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group

acronym: MIRAS

summary:
This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype.

400 patients will be included in this prospective cohort study; they will be identified in the investigating centers in the context of either routine care or a clinical study protocol.

Retrospective cases of patients (100 cases in total) will be identified in all centers through the GSF/GETO clinical databases already setted up (including the clinical base Conticabase).

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancerologie de L'Ouest - Site Rene Gauducheau

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Institut de Cancérologie Strasbourg Europe


title: Multidimensional Assessment of Dyspnea in Asthma

acronym: MIDAS

summary:
Breathlessness is a symptom of asthma that occurs in relation with lower airway obstruction. However, this sensation is not specific of asthma and may be the expression of other disorders. In particular, it can testify to anxiety or hyperventilation, two disorders frequently associated with asthma. The systematic interpretation of dyspnea as a manifestation of asthma in asthmatic patients may lead to an inappropriate increase in asthma controllers.

Identifying the cause of dyspnea in asthmatic patients (airway obstruction, anxiety or hyperventilation) is therefore crucial for the clinician.

This could be facilitated by a multidimensional assessment of dyspnea, evaluating the kind of sensation felt by the patient (for example chest tightness, air hunger etc.) and emotions associated to respiratory sensations (for example anxiety, fear etc.).

The objectives of this project are to assess: (1) the sensory and affective dimensions of dyspnea in asthma and, (2) their connection to asthma control, anxiety and depression.

lead_sponsor: University Hospital, Lille

location_facility: Hopital Saint Vincent - Saint Antoine - Lille

location_facility: Hu Paris Nord Site Bichat Aphp - Paris 18

location_facility: Hu Paris Sud Site Kremlin Bicetre Aphp - Le Kremlin Bicetre


title: Phase III Trial to Assess Impact of Ultra-long Versus Long Down-regulation Protocol on IVF/ICSI Outcomes in Infertile Women Presenting With Adenomyosis.

acronym: ADENOFIV

summary:
Adenomyosis is a benign condition defined as the invasion of ectopic endometrium into the myometrium, resulting in smooth muscle hyperplasia and endometrial inflammation, commonly associated with endometriosis and uterine fibroids.

Heterogeneity among studies regarding diagnostic criteria and therapeutic management has fed the debate surrounding the impact of adenomyosis on assisted reproductive therapy outcomes. Nevertheless, recent data support that adenomyosis impairs reproductive outcomes associated with in vitro fertilization (IVF). According to several experimental data, prolonged exposure to gonadotropin releasing hormone (GnRH) agonists may overcome part of the detrimental impact of adenomyosis on fertility outcome. Overall, GnRH agonist treatment resulted in decreased local production of cytochrome P450 aromatase, decreased intrauterine concentration of free radicals and reduced inflammatory response and angiogenesis in endometrium, myometrium and adenomyosis lesions. At the same time, GnRH agonists affect neither endometrial capacity to support invasion nor invasive potential of the blastocyst in the early stages of implantation.

For IVF, 2 main protocols based on GnRH agonist pituitary down-regulation are available:

the long protocol involving a 15 days pituitary down-regulation;
the ultra-long protocol involving a 3 months pituitary down-regulation. Most studies using ultra-long protocol reported similar IVF outcomes in adenomyosis patients and control groups. Conversely, studies involving long or GnRH antagonist protocols demonstrated a significant reduction in clinical and ongoing pregnancy rates in adenomyosis patients compared to control subjects. Thus supporting that ultra-long protocol may be beneficial to improve IVF outcomes in the setting of adenomyosis.This is what investigators would like to demonstrate in this study

status: Withdrawn

lead_sponsor: University Hospital, Toulouse

location_facility: Centre hospitalier intercommunal de Créteil


title: Efficacy of Non-instrumental Pleural Chest Physiotherapy (KRP-NI) in Initial Management of Infectious Pleural Effusion

acronym: KINEPANCH

summary: The main purpose of this study is to assess efficacy of non instrumental pleural chest physiotherapy on the recovery of respiratory function, at hospital discharge or 15 days after beginning the pleural chest physiotherapy, compared to physiotherapy with standard mobilization, in patients with infectious pleural effusion, who have received usual medical treatment.

lead_sponsor: Centre Hospitalier René Dubos

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Intercommunal - Créteil

location_facility: Centre Hospitalier Henri Duffaut - Avignon


title: Evaluation of the Patient Skin Dose in Interventional Radiology

acronym: DPPRI

summary:
Studies on radiation induced patients' skin lesions in interventional radiology highlighted the need for optimized and personalized patient dosimetry and adapted patient follow-up. Measurements using Gafchromic® films or thermoluminescent dosimeters have long been the only way to accurately evaluate the maximum absorbed dose to the patient skin. However as these dose measurements are tedious and expensive, they could not be systematically applicable in clinical practice. Therefore, more practical calculation methods have been developed. These software programs calculate the skin dose using dosimetric information from images DICOM header or radiation dose structured reports (RDSRs). Validation studies of these software programs are rare and when existent have many limitations.

Radiation Dose Monitor (RDM from Medsquare) is a software program for archiving and monitoring of radiation dose (DACS, Dosimetry Archiving Communication System) used in routine in the investigator's hospitals. A new functionality developed in RDM allows quick estimation without in-vivo measurements of the absorbed dose to the skin of the patient. Comparing RDM calculations with in-vivo measurements will enable this software validation so that it can be used in clinical routine.

Main objective: to validate RDM software for calculating patient skin dose in interventional radiology.

ReferenceCitation: Food and Drug Administration (FDA). Avoidance of serious x-ray-induced skin injuries to patients during fluoroscopically-guided procedures, 1994.

ReferenceCitation: Valentin J. Avoidance of radiation injuries from medical interventional procedures. Ann ICRP. 2000;30(2):7-67. Review.

ReferenceCitation: Miller DL. Efforts to optimize radiation protection in interventional fluoroscopy. Health Phys. 2013 Nov;105(5):435-44. doi: 10.1097/HP.0b013e31829c355a. Review.

ReferenceCitation: Bor D, Olğar T, Toklu T, Cağlan A, Onal E, Padovani R. Patient doses and dosimetric evaluations in interventional cardiology. Phys Med. 2009 Mar;25(1):31-42. doi: 10.1016/j.ejmp.2008.03.002. Epub 2008 Apr 25.

ReferenceCitation: Ying CK, Kandaiya S. Patient skin dose measurements during coronary interventional procedures using Gafchromic film. J Radiol Prot. 2010 Sep;30(3):585-96. doi: 10.1088/0952-4746/30/3/012. Epub 2010 Sep 8.

ReferenceCitation: Giordano C, D'Ercole L, Gobbi R, Bocchiola M, Passerini F. Coronary angiography and percutaneous transluminal coronary angioplasty procedures: Evaluation of patients' maximum skin dose using Gafchromic films and a comparison of local levels with reference levels proposed in the literature. Phys Med. 2010 Oct;26(4):224-32. doi: 10.1016/j.ejmp.2010.01.001. Epub 2010 Feb 8.

ReferenceCitation: den Boer A, de Feijter PJ, Serruys PW, Roelandt JR. Real-time quantification and display of skin radiation during coronary angiography and intervention. Circulation. 2001 Oct 9;104(15):1779-84.

ReferenceCitation: Balter S. Methods for measuring fluoroscopic skin dose. Pediatr Radiol. 2006 Sep;36 Suppl 2:136-40. Review.

ReferenceCitation: Chida K, Kagaya Y, Saito H, Takai Y, Takahashi S, Yamada S, Kohzuki M, Zuguchi M. Total entrance skin dose: an effective indicator of maximum radiation dose to the skin during percutaneous coronary intervention. AJR Am J Roentgenol. 2007 Oct;189(4):W224-7.

ReferenceCitation: Khodadadegan Y, Zhang M, Pavlicek W, Paden RG, Chong B, Schueler BA, Fetterly KA, Langer SG, Wu T. Automatic monitoring of localized skin dose with fluoroscopic and interventional procedures. J Digit Imaging. 2011 Aug;24(4):626-39. doi: 10.1007/s10278-010-9320-7.

ReferenceCitation: Sanchez RM, Vano E, Fernandez JM, Escaned J. Evaluation of a real-time display for skin dose map in cardiac catheterisation procedures. Radiat Prot Dosimetry. 2015 Jul;165(1-4):240-3. doi: 10.1093/rpd/ncv033. Epub 2015 Mar 18.

ReferenceCitation: Digital Imaging and Communications in Medicine (DICOM). Supplement 94: Diagnostic X-Ray radiation Dose Reporting (Dose SR), 2005.

ReferenceCitation: 1IEC/PAS 61910-1. Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured report for radiography and radioscopy, 2007.

ReferenceCitation: IEC/PAS 61910-1. Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured report for radiography and radioscopy, 2014.

ReferenceCitation: Johnson PB, Borrego D, Balter S, Johnson K, Siragusa D, Bolch WE. Skin dose mapping for fluoroscopically guided interventions. Med Phys. 2011 Oct;38(10):5490-9. doi: 10.1118/1.3633935.

ReferenceCitation: Khodadadegan Y, Zhang M, Pavlicek W, Paden RG, Chong B, Huettl EA, Schueler BA, Fetterly KA, Langer SG, Wu T. Validation and initial clinical use of automatic peak skin dose localization with fluoroscopic and interventional procedures. Radiology. 2013 Jan;266(1):246-55. doi: 10.1148/radiol.12112295. Epub 2012 Nov 9.

ReferenceCitation: Bordier C, Klausz R, Desponds L. Patient dose map indications on interventional X-ray systems and validation with Gafchromic XR-RV3 film. Radiat Prot Dosimetry. 2015 Feb;163(3):306-18. doi: 10.1093/rpd/ncu181. Epub 2014 Jun 17.

ReferenceCitation: Bednarek DR, Barbarits J, Rana VK, Nagaraja SP, Josan MS, Rudin S. Verification of the performance accuracy of a real-time skin-dose tracking system for interventional fluoroscopic procedures. Proc SPIE Int Soc Opt Eng. 2011 Feb 13;7961(796127). pii: 796127_1.

ReferenceCitation: Rana VK, Rudin S, Bednarek DR. A tracking system to calculate patient skin dose in real-time during neurointerventional procedures using a biplane x-ray imaging system. Med Phys. 2016 Sep;43(9):5131. doi: 10.1118/1.4960368.

ReferenceCitation: Greffier J, Van Ngoc Ty C, Bonniaud G, Moliner G, Ledermann B, Schmutz L, Cornillet L, Cayla G, Beregi JP, Pereira F. Assessment of peak skin dose in interventional cardiology: A comparison between Gafchromic film and dosimetric software em.dose. Phys Med. 2017 Jun;38:16-22. doi: 10.1016/j.ejmp.2017.05.044. Epub 2017 May 8.

ReferenceCitation: Magnier F, Poulin M, Van Ngoc Ty C, Osmond E, Bonniaud G, Coulot J, Pereira B, Boyer L, Guersen J, Cassagnes L. Comparison of Patient Skin Dose Evaluated Using Radiochromic Film and Dose Calculation Software. Cardiovasc Intervent Radiol. 2018 May;41(5):762-771. doi: 10.1007/s00270-018-1888-1. Epub 2018 Feb 7.

ReferenceCitation: Jones AK, Pasciak AS. Calculating the peak skin dose resulting from fluoroscopically guided interventions. Part I: Methods. J Appl Clin Med Phys. 2011 Nov 15;12(4):3670. doi: 10.1120/jacmp.v12i4.3670. Review. Erratum in: J Appl Clin Med Phys. 2014 Jul;15(4):402.

ReferenceCitation: Benmakhlouf H, Bouchard H, Fransson A, Andreo P. Backscatter factors and mass energy-absorption coefficient ratios for diagnostic radiology dosimetry. Phys Med Biol. 2011 Nov 21;56(22):7179-204. doi: 10.1088/0031-9155/56/22/012. Epub 2011 Oct 25.

ReferenceCitation: Menzel HG, Clement C, DeLuca P. ICRP Publication 110. Realistic reference phantoms: an ICRP/ICRU joint effort. A report of adult reference computational phantoms. Ann ICRP. 2009;39(2):1-164. doi: 10.1016/j.icrp.2009.09.001. Erratum in: Ann ICRP. 2009;39(2):165.

ReferenceCitation: IEC 61267. Medical Diagnostic X-ray Equipment - Radiation Conditions for Use in the Determination of Characteristics, 2005.

ReferenceCitation: Greffier J, Van Ngoc Ty C, Agelou M, Coulot J, Ledermann B, Ovtchinnikoff S, Pereira F, Beregi JP, Bonniaud G. Impact of the calibration conditions of XR-RV3 films on peak skin dose measurements in interventional radiology. Radiat Prot Dosimetry. 2017 Apr 25;174(2):207-215. doi: 10.1093/rpd/ncw116.

ReferenceCitation: McCabe BP, Speidel MA, Pike TL, Van Lysel MS. Calibration of GafChromic XR-RV3 radiochromic film for skin dose measurement using standardized x-ray spectra and a commercial flatbed scanner. Med Phys. 2011 Apr;38(4):1919-30.

ReferenceCitation: Farah J, Trianni A, Ciraj-Bjelac O, Clairand I, De Angelis C, Delle Canne S, Hadid L, Huet C, Jarvinen H, Negri A, Novák L, Pinto M, Siiskonen T, Waryn MJ, Knežević Ž. Characterization of XR-RV3 GafChromic(®) films in standard laboratory and in clinical conditions and means to evaluate uncertainties and reduce errors. Med Phys. 2015 Jul;42(7):4211-26. doi: 10.1118/1.4922132.

ReferenceCitation: Miyake Et Al H. [Medical electrical equipment - part 2-43: particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures]. Nihon Hoshasen Gijutsu Gakkai Zasshi. 2011;67(3):298-301. Japanese.

location_facility: AP-HP, Cochin Hospital, Radiology A department

location_facility: AP-HP, Necker-Enfants Malades Hospital, Pediatric radiology department

location_facility: AP-HP, Lariboisière Hospital, Cardiology department

location_facility: AP-HP, Lariboisière Hospital, Neuroradiology department

location_facility: AP-HP, Bicêtre Hospital, Nuclear medicine department


title: Prevalence and Vulnerability Factors of Active Cybersexuality Among Teenagers (15 - 17 Olds) in West Normandy.

summary: This study evaluates prevalence of active cybersexuality among teenagers (15-17 old) in West Normandy and find different factors of vulnerability that could induce this behaviour. Selection of teenagers in different schools (general, professional, agricultural, reintegration structure).

ReferenceCitation: Braun-Courville DK, Rojas M. Exposure to sexually explicit Web sites and adolescent sexual attitudes and behaviors. J Adolesc Health. 2009 Aug;45(2):156-62. doi: 10.1016/j.jadohealth.2008.12.004. Epub 2009 Feb 20.

ReferenceCitation: Strassberg DS, McKinnon RK, Sustaíta MA, Rullo J. Sexting by high school students: an exploratory and descriptive study. Arch Sex Behav. 2013 Jan;42(1):15-21. doi: 10.1007/s10508-012-9969-8. Epub 2012 Jun 7.

ReferenceCitation: Temple JR, Paul JA, van den Berg P, Le VD, McElhany A, Temple BW. Teen sexting and its association with sexual behaviors. Arch Pediatr Adolesc Med. 2012 Sep;166(9):828-33. doi: 10.1001/archpediatrics.2012.835.

ReferenceCitation: Strassberg DS, Cann D, Velarde V. Sexting by High School Students. Arch Sex Behav. 2017 Aug;46(6):1667-1672. doi: 10.1007/s10508-016-0926-9. Epub 2017 Jan 3.

ReferenceCitation: Rice E, Gibbs J, Winetrobe H, Rhoades H, Plant A, Montoya J, Kordic T. Sexting and sexual behavior among middle school students. Pediatrics. 2014 Jul;134(1):e21-8. doi: 10.1542/peds.2013-2991.

lead_sponsor: University Hospital, Caen

location_facility:
Lycée jules verne
Lycée marie curie
IME
CIFAC
Lycée Allende
Cfai Uimm
ICEP CFA
MFR
EPEI
MFR TRUN
Lycée Laplace
Lycée Millet
La roquelle
Lycée de navarre


title: SPONDIMMO : Multicentered Descriptive Prospective Study of Immobilization and Neurological Complication in Patients With Vertebral Osteomyelitis.

acronym: SPONDIMMO

summary:
Vertebral osteomyelitis is an infection of the intervertebral disk and adjacent vertebral plates with a non-negligible risk of neurological complications and handicap. If there are clear recommendations dealing with antibiotic therapy and surgery indications for this pathogen, the question of the immobilization will be remaining debate. The aim of the study was to describe protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers. The secondary objectives were to evaluate the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications.

The investigators also aim to search for association between type and duration of spine immobilization and neurological status at the end of follow-up.

lead_sponsor: Nantes University Hospital

location_facility:
Clermont ferrand University Hospital
Saint-Nazaire Hospital
Tours University Hospital
La Roche Sur Yon Hospital
Paris University Hospital
Rennes University Hospital
Quimper Hospital
Angers University Hospital
Nantes University Hospital


title: A Randomised, Open-label, Multicentre, Phase 3 Trial of First-line Treatment With Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects With Steroid-refractory Acute Graft-versus-host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)

acronym: IDUNN

summary: The primary purpose of this trial is to demonstrate the superiority of MC0518 compared to the first used best available therapy (BAT) with respect to overall response rate (ORR) in adult and adolescent participants with steroid-refractory acute graft-versus-host disease (SR-aGvHD) at Day 28.

lead_sponsor: medac GmbH

location_country: Poland Spain Sweden France Germany

location_facility: Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik II - Zentrum fuer Allogene Blutstammzelltransplantation

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Department of Pediatric Hematology, Oncology and BMT, Wroclaw Medical University

location_facility: Klinikum der Johann Wolfgang Goethe University

location_facility: CHU Jean Minjoz Boulevard Fleming Besancon

location_facility: CHU de Nantes - Hotel Dieu 1 Place Alexis Ricordeau Nantes

location_facility: Centre Hospitalier Lyon Sud Pavillon Marcel Berard 1G

location_facility: University Hospital Tuebingen Medical Center

location_facility: Universitaetsklinikum Freiburg - Zentrum fuer Kinder- und Jugendmedizin (ZKJ) - Klinik fuer Paediatrische Haematologie und Onkologie

location_facility: Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud Avenue Rene Laennec Amiens

location_facility: Selbststaendige Abteilung fur Haematologie und Internistische Onkologie

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet - Frankfurt am Main

location_facility: Center for Allogeneic Stem Cell Transplantation and Cell Therapy (CAST), Karolinska Universitetssjukhuset Huddinge

location_facility: CHU de Grenoble Hopital Albert Michallon

location_facility: University Hospital Bonn, Medizinische Klinik III

location_facility: Universitaetsklinikum Essen - Klinik fuer Knochenmarktransplantation (KMT)

location_facility: Centre Hospitalier Universitaire CHU de Toulouse


title: A Post-Market Study of Performance and Safety of Low-flow Extracorporeal Carbon Dioxide Removal Using PrismaLung+ in Patients With Mild to Moderate Acute Respiratory Distress Syndrome

summary: PrismaLung+ is indicated to provide extracorporeal carbon dioxide removal (ECCO2R) as a stand-alone therapy or in combination with continuous renal replacement therapy (CRRT). This study is intended for patients with increased levels of Carbon Dioxide (CO2) in their blood and ≥ 18 years old, and will treat patients with mild or moderate acute respiratory distress syndrome (ARDS) using PrismaLung+. The study will assess tidal volume reduction and confirm the safety of PrismaLung+.

lead_sponsor: Baxter Healthcare Corporation


title: A Multicenter, Prospective, Multi-organ Study to Evaluate the Clinical Benefit of an Exome "Complex" Analysis Versus an Exome "Simple" Analysis to Help the Therapeutic Decision for the Precision Medicine

summary:
The "simple" analysis of the exome can determine somatic and constitutional mutations. The major challenge lies in the translation of sequencing data into clinically relevant information allowing the clinician to guide his decision-making A "complex" analysis of the exome would provide access to structural DNA data, concerning mutational signatures, tumor mutational load, analysis of large deletions, loss of heterozygosity as well as amplification of certain genes which may have an impact on the management of patients.

No data available to date makes it possible to assess the clinical interest of the availability of its additional information resulting from a "complex" analysis compared to a "simple" analysis. The objective of the EXOMA2 study is to assess the proportion of patients for whom the proposed therapy is derived from its additional information (complex analysis) and would not have been possible with a classic exome analysis (simple analysis) .

We hereby formulate the hypothesis that a "complex" analysis on a population presenting a metastatic or locally advanced disease treated early (from the 1st line of treatment) will make it possible to determine therapeutic indications which could not be discovered with a "simple" analysis.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
CHU Nantes
CHRU Jean Minjoz
Institut Bergonie
CHU Amiens Picardie
Chu Poitiers
CGFL
Centre Oscar Lambret
CHU François Mitterrand
Institut Hospitalier Franco-Britannique

intervention_type: Genetic


title: Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP)

acronym: DOXYVAC

summary: The study ANRS 174 Doxyvac is a clinical trial that will use Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men and using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP) and vaccination with Bexsero.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Hôpital pitié Salpetrière
Hôpital Necker-Enfants Malades
Hôpital Européen Georges Pompidou
Hôpital Tenon
Hôpital Pitié-Salpétrière
Hôpital Hôtel Dieu
Hôpital Saint-Louis
Hôpital Bichat
Hôpital Saint-Antoine


title: Anti-αIIbβ3 Immunization in Glanzmann Thrombasthenia: Prevalence and Associated Risk Factors: Thrombasthenia Anti-αIIbβ3 Antibodies Study (TAAS)

acronym: TAAS

summary: This project aim to correlate risk factors (genetic, therapeutic and socio-demographic factors) to anti-αIIbβ3 antibodies formation following blood products transfusion (platelets or packed red cells) or pregnancy in a national cohort of GT patients.

lead_sponsor: University Hospital, Bordeaux

location_facility:
CHU Bordeaux - Hôpital Pellegrin
CHU Strasbourg
CHU Bordeaux - Hôpital Haut-Lévêque
CHU Poitiers
Hôpital Bicêtre, APHP
CHU Toulouse
Hôpital la Timone, APHM
CHU Limoges
CHU Nîmes


title: Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy

summary:
CESTO 2 is a 318 participants, 3-arm, multicentric, randomized, double-blind, placebo-controlled Phase II clinical trial.

The main objectives are to select the most efficient dose and to assess long-term efficacy of NFL-101 compared to placebo, for abrupt cessation and for reduction before cessation.

lead_sponsor: NFL Biosciences SAS

location_facility: Centre d'Investigation Clinique de Marseille Nord

location_facility: Centre d'Investigation Clinique de Rennes

location_facility: Centre d'Investigation Clinique de Clermont-Ferrand

location_facility: Centre d'Investigation Clinique de Bordeaux

location_facility: Centre d'Investigation Clinique de Montpellier

location_facility: Centre d'Investigation Clinique de Poitiers (CIC 1402)


title: Intérêt du Traitement de la fièvre Par Refroidissement Externe Pour la Survie Des Patients ventilés en Choc Septique

summary:
The best strategy for managing fever in patients with septic shock remains unknown. In a pilot study, the investigators showed that fever control at normothermia allowed a better control of shock and evolution of organ failures. In this second trial the investigators will conduct a multicentre, open-label, randomized controlled, superiority trial in which two strategies will be compared:

Respect of fever
Fever control at normothermia using external cooling The primary end point will be d-60 mortality.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre hospitalier intercommunal de Créteil

location_facility: Hôpital Lariboisière -Réanimation chirurgicale

location_facility: Hopital Lariboisière - Réanimation Médicale


title: COVID 19 : Seroprevalence Study of Anti SRAS-CoV-2 Antibodies in GHT Employees in Haute Bretagne

acronym: AntiCoV-HB

summary: Since the start of this epidemic, numerous clinical and fundamental studies have been conducted to best adapt the individual management of COVID-19 cases [1-6]. In parallel with this work, it is necessary to better understand the characteristics of the epidemic in the general population but also in the population working in healthcare settings more exposed to SARS-CoV-2. Seroprevalence studies are therefore particularly useful in order to understand the collective immunization rate and the factors that can explain this immunization.

lead_sponsor: Rennes University Hospital

location_facility: CENTRE HOSPITALIER de VITRE_ Saint Jean (La Guerche)


title: COvid-19 and Vitamin D Supplementation: a Multicenter Randomized Controlled Trial of High Dose Versus Standard Dose Vitamin D3 in High-risk COVID-19 Patients (CoVitTrial)

summary:
Vitamin D is a secosteroid hormone produced by the skin during Summer exposure to UVB rays. Hypovitaminosis D is common in Winter (October to March) at Northern latitudes above 20 degrees North, and from April to September at Southern latitudes beyond 20 degrees below the equator.

In the past, coronaviruses and influenza viruses have exhibited very high seasonality, with outbreaks occurring preferentially during the Winter. The Covid-19 pandemic is indeed more severe above Winter latitudes of 20 degrees, while it remains until now less severe in the Southern hemisphere, with a much lower number of deaths.

Preclinical research suggests that the SARS-Cov-2 virus enters cells via the angiotensin converting enzyme 2 (ACE2). Coronavirus viral replication downregulates ACE2, thereby dysregulating the renin-angiotensin system (RAS) and leading to a cytokine storm in the host, causing acute respiratory distress syndrome (ARDS).

Research also shows that vitamin D plays a role in balancing RAS and in reducing lung damage. On the contrary, chronic hypovitaminosis D induces pulmonary fibrosis through activation of RAS. Similarly, hypovitaminosis D has been strongly associated in the literature with ARDS, as well as with a pejorative vital prognosis in resuscitation but also in geriatric units, and with various comorbidities associated to deaths during SARS-Cov-2 infections. Conversely, vitamin D supplementation has been reported to increase immunity and to reduce inflammatory responses and the risk of acute respiratory tract infections.

High-dose oral vitamin D3 supplementation has been shown to decrease short-term mortality in resuscitation patients with severe hypovitaminosis D (17% absolute risk reduction). It is considered safe to take oral vitamin D supplementation at doses up to 10,000 IU/day for short periods, particularly in older adults, i.e. a population that is mostly affected by hypovitaminosis D and who should receive at least 1,500 IU of vitamin D daily to ensure satisfactory vitamin D status.

Vitamin D supplementation is mentioned as a potentially interesting treatment for SARS-Cov-2 infection but on a scientific basis with a low level of evidence until now.

We hypothesize that high-dose vitamin D supplementation improves the prognosis of older patients diagnosed with COVID-19 compared to a standard dose of vitamin D.

ReferenceCitation: Annweiler C, Beaudenon M, Gautier J, Gonsard J, Boucher S, Chapelet G, Darsonval A, Fougere B, Guerin O, Houvet M, Menager P, Roubaud-Baudron C, Tchalla A, Souberbielle JC, Riou J, Parot-Schinkel E, Celarier T; COVIT-TRIAL study group. High-dose versus standard-dose vitamin D supplementation in older adults with COVID-19 (COVIT-TRIAL): A multicenter, open-label, randomized controlled superiority trial. PLoS Med. 2022 May 31;19(5):e1003999. doi: 10.1371/journal.pmed.1003999. eCollection 2022 May.

ReferenceCitation: Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16.

ReferenceCitation: Annweiler C, Beaudenon M, Gautier J, Simon R, Dubée V, Gonsard J, Parot-Schinkel E; COVIT-TRIAL study group. COvid-19 and high-dose VITamin D supplementation TRIAL in high-risk older patients (COVIT-TRIAL): study protocol for a randomized controlled trial. Trials. 2020 Dec 28;21(1):1031. doi: 10.1186/s13063-020-04928-5.

lead_sponsor: University Hospital, Angers

location_facility:
CHU Nantes
CHU Saint Etienne
CHU Tours
CH Saumur
CHU Angers
CHU Bordeaux
CH Le Mans
CHU Limoges
CHU Nice