title: Prospective and Retrospective Memory Perception Assessment in Central/Non-central Nervous System Cancers

acronym: PROMESSE

summary:
Prospective memory (PM) is the ability to implement intended actions in the future. It allows maintaining and retrieving future plans, goals, and activities (i.e., remember to remember). PM is associated with most everyday memory problems . PM is crucial to correctly respond to all the social, occupational and working demands of everyday life, to perform many deferred health-related actions and is involved in therapeutic adherence .

Indeed, PM errors are an important part of the aging memory complaints. The prevalence of self-reported PM failures is also significant among young adults, compared with self-reported retrospective memory (RM) failures .Yet, PM errors are major sources of frustration and embarrassment .

In oncology, recently investigated the self-reported memory complaints in a 80 case-healthy-control study breast patients . Subjective memory complaints were assessed using the Prospective and Retrospective Memory Questionnaire . Results from the Paquet et al. study show that all participants (i.e., both patients and matched-controls) reported more PM than RM failures in daily-life (p<.001). Breast cancer patients reported more RM and PM failures than controls. However, this group effect was no longer statistically significant when controlling for depression and fatigue.

These findings are consistent with the view that memory complaints are closely associated with depression and cancer-related fatigue, and more generally with psychopathological variables .As underlined by Paquet et al. subjective memory complaints should be investigated because they refer to some aspects of the cancer experience that could potentially be linked to quality of life. Thus, it is important to explore psychopathological basis such as depression, anxiety and fatigue while investigating self-reported memory failures in cancer patients.

Despites the importance of PM, there have been, to our knowledge, only few studies evaluating PM complaints or PM functioning in patients diagnosed with an intracerebral tumor (such as Diffuse Low-Grade Glioma- DLGG- or glioblastome- GB) or extra-cerebral tumor (such as breast cancer - BC). Therefore, the investigators thought it would be useful, as a first step, to conduct a study to explore and to manage the PM and RM subjective complaints in cancer patients compared to another chronic disease, such as HIV. In fine, these data will help to identify a new target for psychological management focused on either psychopathological or neuropsychological rehabilitation

ReferenceCitation: Bedard M, Verma S, Collins B, Song X, Paquet L. Prospective memory impairment in chemotherapy-exposed early breast cancer survivors: Preliminary evidence from a clinical test. J Psychosoc Oncol. 2016 Jul-Aug;34(4):291-304. doi: 10.1080/07347332.2016.1181133. Epub 2016 Apr 28.

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ReferenceCitation: Cheng H, Yang Z, Dong B, Chen C, Zhang M, Huang Z, Chen Z, Wang K. Chemotherapy-induced prospective memory impairment in patients with breast cancer. Psychooncology. 2013 Oct;22(10):2391-5. doi: 10.1002/pon.3291. Epub 2013 May 15.

ReferenceCitation: Crawford JR, Henry JD, Ward AL, Blake J. The Prospective and Retrospective Memory Questionnaire (PRMQ): latent structure, normative data and discrepancy analysis for proxy-ratings. Br J Clin Psychol. 2006 Mar;45(Pt 1):83-104. doi: 10.1348/014466505X28748.

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ReferenceCitation: Dieckmann P, Reddersen S, Wehner T, Rall M. Prospective memory failures as an unexplored threat to patient safety: results from a pilot study using patient simulators to investigate the missed execution of intentions. Ergonomics. 2006 Apr 15-May 15;49(5-6):526-43. doi: 10.1080/00140130600568782.

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ReferenceCitation: Kliegel M, Altgassen M, Hering A, Rose NS. A process-model based approach to prospective memory impairment in Parkinson's disease. Neuropsychologia. 2011 Jul;49(8):2166-77. doi: 10.1016/j.neuropsychologia.2011.01.024. Epub 2011 Jan 19.

ReferenceCitation: Kliegel M, Martin M, McDaniel MA, Einstein GO. Varying the importance of a prospective memory task: differential effects across time- and event-based prospective memory. Memory. 2001 Jan;9(1):1-11. doi: 10.1080/09658210042000003.

ReferenceCitation: Kvavilashvili L, Kornbrot DE, Mash V, Cockburn J, Milne A. Differential effects of age on prospective and retrospective memory tasks in young, young-old, and old-old adults. Memory. 2009 Feb;17(2):180-96. doi: 10.1080/09658210802194366.

ReferenceCitation: Lange M, Joly F. How to Identify and Manage Cognitive Dysfunction After Breast Cancer Treatment. J Oncol Pract. 2017 Dec;13(12):784-790. doi: 10.1200/JOP.2017.026286.

ReferenceCitation: Martin S, Mazzocco C, Maury P, Grosselin A, Van der Elst W, Dixon RA, Brouillet D. Compensating for memory losses throughout aging: validation and normalization of the memory compensation questionnaire (MCQ) for non-clinical French populations. Arch Gerontol Geriatr. 2015 Jan-Feb;60(1):28-38. doi: 10.1016/j.archger.2014.10.013. Epub 2014 Oct 22.

ReferenceCitation: Meyers CA, Wefel JS. The use of the mini-mental state examination to assess cognitive functioning in cancer trials: no ifs, ands, buts, or sensitivity. J Clin Oncol. 2003 Oct 1;21(19):3557-8. Epub 2003 Aug 11.

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ReferenceCitation: Paquet L, Collins B, Song X, Chinneck A, Bedard M, Verma S. A pilot study of prospective memory functioning in early breast cancer survivors. Breast. 2013 Aug;22(4):455-61. doi: 10.1016/j.breast.2013.04.002. Epub 2013 May 4.

ReferenceCitation: Paquet L, Verma S, Collins B, Chinneck A, Bedard M, Song X. Testing a novel account of the dissociation between self-reported memory problems and memory performance in chemotherapy-treated breast cancer survivors. Psychooncology. 2018 Jan;27(1):171-177. doi: 10.1002/pon.4389. Epub 2017 Feb 10.

ReferenceCitation: Woods SP, Moran LM, Dawson MS, Carey CL, Grant I; HIV Neurobehavioral Research Center (HNRC) Group. Psychometric characteristics of the memory for intentions screening test. Clin Neuropsychol. 2008 Sep;22(5):864-78. doi: 10.1080/13854040701595999.

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ReferenceCitation: Scullin MK, McDaniel MA, Shelton JT. The Dynamic Multiprocess Framework: evidence from prospective memory with contextual variability. Cogn Psychol. 2013 Aug-Sep;67(1-2):55-71. doi: 10.1016/j.cogpsych.2013.07.001. Epub 2013 Aug 3.

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ReferenceCitation: Smith T, Gildeh N, Holmes C. The Montreal Cognitive Assessment: validity and utility in a memory clinic setting. Can J Psychiatry. 2007 May;52(5):329-32.

ReferenceCitation: Woods SP, Carey CL, Moran LM, Dawson MS, Letendre SL, Grant I; HIV Neurobehavioral Research Center (HNRC) Group. Frequency and predictors of self-reported prospective memory complaints in individuals infected with HIV. Arch Clin Neuropsychol. 2007 Feb;22(2):187-95. doi: 10.1016/j.acn.2006.12.006. Epub 2007 Feb 6.

ReferenceCitation: Zeintl M, Kliegel M, Rast P, Zimprich D. Prospective memory complaints can be predicted by prospective memory performance in older adults. Dement Geriatr Cogn Disord. 2006;22(3):209-15. doi: 10.1159/000094915. Epub 2006 Aug 7.

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location_facility:
CHU Lyon
Hopital saint Louis
CHU D'amiens
Icm Val D'Aurelle
Hôpital d'Instruction des Armées
UFR de Psychologie Université de Lille


title: Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial

acronym: RESECT COLON

summary:
Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2% However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.

Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.

We therefore propose to compare these two endoscopic resection strategies in terms of recurrence rate at 6 months and to estimate the differential cost-effectiveness and cost-utility ratios over a 36-month time horizon.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: University Hospital, Limoges

location_facility:
Cochin Hospital
Pontchaillou Hospital
Jean Mermoz Hospital
Edouard Herriot Hospital
University Hospital, Limoges
Nancy University Hospital

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Sorafenib-Regorafenib Sequence Treatment Monitoring Study Using Liquid Biopsy

acronym: HELP

summary: The aim of this trial is to investigate whether quantitative analysis of the total concentration of circulating free deoxyribonucleic acid (cfDNA) and of the cfDNA integrity index (DII) (Intplex®) may reflect hepatocellular carcinoma (HCC) tumor dynamics or response for patients treated by Sorafenib or Regorafenib and if it could be used as a tool for patient management under targeted therapy.

status: Terminated

study_completion_date_type: Actual

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Gupta S, Bent S, Kohlwes J. Test characteristics of alpha-fetoprotein for detecting hepatocellular carcinoma in patients with hepatitis C. A systematic review and critical analysis. Ann Intern Med. 2003 Jul 1;139(1):46-50. Review.

ReferenceCitation: Riaz A, Ryu RK, Kulik LM, Mulcahy MF, Lewandowski RJ, Minocha J, Ibrahim SM, Sato KT, Baker T, Miller FH, Newman S, Omary R, Abecassis M, Benson AB 3rd, Salem R. Alpha-fetoprotein response after locoregional therapy for hepatocellular carcinoma: oncologic marker of radiologic response, progression, and survival. J Clin Oncol. 2009 Dec 1;27(34):5734-42. doi: 10.1200/JCO.2009.23.1282. Epub 2009 Oct 5.

ReferenceCitation: Chan SL, Mo FK, Johnson PJ, Hui EP, Ma BB, Ho WM, Lam KC, Chan AT, Mok TS, Yeo W. New utility of an old marker: serial alpha-fetoprotein measurement in predicting radiologic response and survival of patients with hepatocellular carcinoma undergoing systemic chemotherapy. J Clin Oncol. 2009 Jan 20;27(3):446-52. doi: 10.1200/JCO.2008.18.8151. Epub 2008 Dec 8.

ReferenceCitation: Duvoux C, Roudot-Thoraval F, Decaens T, Pessione F, Badran H, Piardi T, Francoz C, Compagnon P, Vanlemmens C, Dumortier J, Dharancy S, Gugenheim J, Bernard PH, Adam R, Radenne S, Muscari F, Conti F, Hardwigsen J, Pageaux GP, Chazouillères O, Salame E, Hilleret MN, Lebray P, Abergel A, Debette-Gratien M, Kluger MD, Mallat A, Azoulay D, Cherqui D; Liver Transplantation French Study Group. Liver transplantation for hepatocellular carcinoma: a model including α-fetoprotein improves the performance of Milan criteria. Gastroenterology. 2012 Oct;143(4):986-94.e3; quiz e14-5. doi: 10.1053/j.gastro.2012.05.052. Epub 2012 Jun 29.

ReferenceCitation: Personeni N, Bozzarelli S, Pressiani T, Rimassa L, Tronconi MC, Sclafani F, Carnaghi C, Pedicini V, Giordano L, Santoro A. Usefulness of alpha-fetoprotein response in patients treated with sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2012 Jul;57(1):101-7. doi: 10.1016/j.jhep.2012.02.016. Epub 2012 Mar 10.

ReferenceCitation: Yamashita T, Forgues M, Wang W, Kim JW, Ye Q, Jia H, Budhu A, Zanetti KA, Chen Y, Qin LX, Tang ZY, Wang XW. EpCAM and alpha-fetoprotein expression defines novel prognostic subtypes of hepatocellular carcinoma. Cancer Res. 2008 Mar 1;68(5):1451-61. doi: 10.1158/0008-5472.CAN-07-6013.

ReferenceCitation: Sozzi G, Conte D, Mariani L, Lo Vullo S, Roz L, Lombardo C, Pierotti MA, Tavecchio L. Analysis of circulating tumor DNA in plasma at diagnosis and during follow-up of lung cancer patients. Cancer Res. 2001 Jun 15;61(12):4675-8.

ReferenceCitation: Thierry AR, Mouliere F, El Messaoudi S, Mollevi C, Lopez-Crapez E, Rolet F, Gillet B, Gongora C, Dechelotte P, Robert B, Del Rio M, Lamy PJ, Bibeau F, Nouaille M, Loriot V, Jarrousse AS, Molina F, Mathonnet M, Pezet D, Ychou M. Clinical validation of the detection of KRAS and BRAF mutations from circulating tumor DNA. Nat Med. 2014 Apr;20(4):430-5. doi: 10.1038/nm.3511. Epub 2014 Mar 23.

ReferenceCitation: Thierry AR, El Messaoudi S, Gahan PB, Anker P, Stroun M. Origins, structures, and functions of circulating DNA in oncology. Cancer Metastasis Rev. 2016 Sep;35(3):347-76. doi: 10.1007/s10555-016-9629-x. Review.

ReferenceCitation: Ono A, Fujimoto A, Yamamoto Y, Akamatsu S, Hiraga N, Imamura M, Kawaoka T, Tsuge M, Abe H, Hayes CN, Miki D, Furuta M, Tsunoda T, Miyano S, Kubo M, Aikata H, Ochi H, Kawakami YI, Arihiro K, Ohdan H, Nakagawa H, Chayama K. Circulating Tumor DNA Analysis for Liver Cancers and Its Usefulness as a Liquid Biopsy. Cell Mol Gastroenterol Hepatol. 2015 Jun 17;1(5):516-534. doi: 10.1016/j.jcmgh.2015.06.009. eCollection 2015 Sep.

ReferenceCitation: Jiang P, Chan CW, Chan KC, Cheng SH, Wong J, Wong VW, Wong GL, Chan SL, Mok TS, Chan HL, Lai PB, Chiu RW, Lo YM. Lengthening and shortening of plasma DNA in hepatocellular carcinoma patients. Proc Natl Acad Sci U S A. 2015 Mar 17;112(11):E1317-25. doi: 10.1073/pnas.1500076112. Epub 2015 Feb 2.

ReferenceCitation: Diaz LA Jr, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol. 2014 Feb 20;32(6):579-86. doi: 10.1200/JCO.2012.45.2011. Epub 2014 Jan 21. Review.

ReferenceCitation: El Messaoudi S, Mouliere F, Du Manoir S, Bascoul-Mollevi C, Gillet B, Nouaille M, Fiess C, Crapez E, Bibeau F, Theillet C, Mazard T, Pezet D, Mathonnet M, Ychou M, Thierry AR. Circulating DNA as a Strong Multimarker Prognostic Tool for Metastatic Colorectal Cancer Patient Management Care. Clin Cancer Res. 2016 Jun 15;22(12):3067-77. doi: 10.1158/1078-0432.CCR-15-0297. Epub 2016 Feb 4.

ReferenceCitation: Mouliere F, El Messaoudi S, Pang D, Dritschilo A, Thierry AR. Multi-marker analysis of circulating cell-free DNA toward personalized medicine for colorectal cancer. Mol Oncol. 2014 Jul;8(5):927-41. doi: 10.1016/j.molonc.2014.02.005. Epub 2014 Mar 24.

ReferenceCitation: Zonta E, Nizard P, Taly V. Assessment of DNA Integrity, Applications for Cancer Research. Adv Clin Chem. 2015;70:197-246. doi: 10.1016/bs.acc.2015.03.002. Epub 2015 Apr 11. Review.

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

location_facility:
CHRU de Lille - Hôpital Claude Duriez
CHU Grenoble - Hôpital Michalon
CHRU Nancy - Hôpital Brabois
Hôpital Beaujon
Hôpital Hôtel Dieu
Hôpital Saint-Eloi

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


title: "Impact of Pelvic Floor Prehabilitation Using Biofeedback on the Severity of the Low Anterior Resection Syndrome in Patients Undergoing a Total Mesorectal Excision for Rectal Cancer"

acronym: CONTICARE

summary:
There is currently no specific treatment and only few measures to prevent the low anterior resection syndrome (LARS). The LARS often results in a severe alteration of quality of life. This study is designed to assess pelvic floor prehabilitation using biofeedback in the prevention of LARS following total mesorectal excision for cancer. The pelvic floor rehabilitation with biofeedback has already been tested postoperatively in patients suffering from LARS with heterogeneous results. However, this rehabilitation has never been evaluated in the prevention of LARS.

The prehabilitation is an innovative concept currently evaluated in the prevention of functional complications following orthopedic surgery and also prostate surgery. In high-risk abdominal surgery, cardiopulmonary prehabilitation offers satisfying results in terms of morbidity and mortality rates. This study will be the first to assess pelvic floor prehabilitation in the prevention of LARS.

status: Unknown status

lead_sponsor: Nantes University Hospital

location_facility:
CHU Angers
Clinic Jules Verne
APHP-Hôpital Beaujon
CHU de Poitiers
CHU de Tours
CHD Vendée


title: Efficacy of Multidimensional Management of Mild Traumatic Brain Injury : A Randomised Clinical Trial

summary: Unfavorable outcomes (UO) are seen in 15 to 20% of patients with mild traumatic brain injury (mTBI). Early identification of patients at risk for UO is crucial for suitable management to be initiated, increasing their chances for a return to a normal life. The investigators previously developed a diagnostic tool enabling early identification (8 to 21 days after the injury) of patients likely to develop UO. In the present study, the investigators examined the value and beneficial effects of early multidimensional management (MM) on prognosis. The investigators used a diagnostic tool to classify 221 mTBI patients as UO (97) or FO (favorable outcome) (124). Patients whose initial risk factors point to UO are at risk of developing post-concussion syndrome (PCS). UO patients were randomized into 2 groups: a group that underwent MM (cognitive-behavioral rehabilitation) (34) and a group with no specific management (46). At 6 months, these 2 groups were compared and the impact of MM on outcome was assessed. Among patients initially classified as FO (101), 95% had FO at 6 months and only 5 had PCS as defined by DSM-IV classification. Of the UO patients who received MM, 94% had no PCS 6 months after injury, whereas 52% of the UO patients who did not receive MM had persistent PCS. The effect of MM on the recovery of patients at 6 months, once adjusted for the main confounding factors, was statistically significant (p<0.001). These results show that the initiation of MM after early identification of at-risk mTBI patients can considerably improves their prognosis.

status: Completed

primary_purpose: Other

ReferenceType: derived

ReferenceCitation: Caplain S, Chenuc G, Blancho S, Marque S, Aghakhani N. Efficacy of Psychoeducation and Cognitive Rehabilitation After Mild Traumatic Brain Injury for Preventing Post-concussional Syndrome in Individuals With High Risk of Poor Prognosis: A Randomized Clinical Trial. Front Neurol. 2019 Sep 4;10:929. doi: 10.3389/fneur.2019.00929. eCollection 2019.

lead_sponsor: Institut de Recherche sur la Moelle épinière et l'Encéphale

location_facility:
Chu Bichat/Beaujon
Chu Bicetre
Chu Tenon
Chu Rouen
Chu Montpellier
CHU St ANTOINE

status_simplified: Completed


title: Apathy in Late Life Depression: New Biomarkers Using Actimetry and Magnetic Resonance Imaging

acronym: ACTIDEP

summary: Old age (> 60 years) is at high risk to develop major depression disorders (MDD). MDD doubles the risk for subsequent cognitive disorders and dementia. Apathy (i.e. the lack of motivation) is a core problem in depression in older age and is frequently associated with cognitive decline in people who have mild cognitive disorders. The investigator propose here to combine actimetry (the measurement of motor activity using a simple device worn at the wrist) and brain imaging to show that it's possible to measure apathy using actimetry in a population of elders with MDD. Having shown that apathy can reliably be measured with actimetry and that it is associated with brain abnormalities, the investigator will be able to test whether actimetry can predict cognitive decline in elders with MDD and can be routinely used in a day-to-day medical practice.

design_allocation: Non-Randomized

lead_sponsor: Rennes University Hospital

location_facility: Centre Mémoire de Ressources et de Recherche (CMRR),

location_facility: Centre Hospitalier Guillaume Régnier, Pôle Hospitalo-Universitaire de Psychiatrie Adulte

location_facility: Service de Radiologie- Neuroradiologie,CHU bretonneau

location_facility: CHU Bretonneau, Consultations Intersectorielles de Gérontopsychiatrie

location_facility: CHU Pontchaillou, Département de Radiologie et d'Imagerie Médicale

intervention_type: Other


title: TransIent Perivascular Inflammation of the Carotid Artery (TIPIC) Syndrome: Clinical and Radiological Follow-up

acronym: TIPIC-UNV

summary: TIPIC syndrome (previously called carotidynia) is a rare entity of unknown cause, where the patient has a temporary cervical pain associated with a suggestive inflammation around the carotid artery. Usually considered as a unique and benign episode, some patients have recurrences and the follow-up is usually short. In this study the investigators aim to evaluate patients who presented a TIPIC episode at least 3 months before, clinically and with a cervical doppler ultrasound

study_type: Observational

time_perspective: Prospective

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild

intervention_type: Biological


type: Other Identifier

title: Early Palliative Care for Patients With Haematological Malignancies: A Randomised Prospective Study

acronym: CALVI

summary:
Patients suffering from haematological disease present symptoms of discomfort and currently benefit from palliative care skills only for the management of their end-of-life. However, in medical oncology, more and more studies tend to demonstrate the benefit on the quality of life of an early collaboration between the two specialties.

Investigator did the hypothesis that early integration of palliative care with conventional haematological care could decrease discomfort symptoms and add a real benefit on the patients' quality of life .

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Centre Hospitalier Métropole Savoie
Institut de Cancérologie de la Loire
Centre Léon Bérard
Chu Clermont-Ferrand
CH Jacques Lacarin
Chu Limoges

intervention_type: Drug


title: Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography

acronym: DOCTA

summary: This is a non-interventional, longitudinal, retrospective and prospective, non-controlled, single arm study in naive or non-naive patients with diabetic macular edema for which aflibercept (EYLEA®) therapy is indicated.

time_perspective: Other

lead_sponsor: Aquitania Opthalmologica

location_facility:
Hôpital de la Croix-Rousse
CHU Nantes
CHU Strasbourg
CHU Bordeaux
CHU Nice
CHU Dijon


title: Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years

acronym: Steinert

summary: The aim of this study is to determine the factors associated with alveolar hypoventilation in terms of cognitive impairment, daytime sleepiness, respiratory function, nocturnal respiratory events This evaluation will clarify the clinical phenotypes of respiratory disease in myotonic steinert dystrophy.

lead_sponsor: University Hospital, Lille

location_facility: Chu de Nantes :Site Hôtel-Dieu- Hme - Nantes 1


title: Evaluation of the Prevalence of Oculomotor Disorders in Patients With Radiologically Isolated Syndrome

acronym: OCRIS

summary: This study aims to investigate the prevalence of subclinical oculomotor disorders in a population of patients with radiologically isolated syndrome.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Pitié Salpêtrière University Hospital (APHP)


title: Multi-Omics and IPSCs to Improve the Diagnosis of Rare Intellectual Disabilities

acronym: MIDRID

summary:
Background Genetic factors play a major role in intellectual disability (ID) but the underlying cause is not determined in many cases.

This proposal is the continuation of the previous interregional project HUGODIMS, the aim of which was to perform whole exome sequencing (WES) in 69 thoroughly selected simplex ID parent-child trios. Thanks to HUGODIMS consortium, the underlying genetic cause of ID was determined or highly suspected in 48 cases (69.5%) and 7 novel ID genes were identified.

Hypothesis Investigators hypothesize that an approach combining genomics, transcriptomics, metabolomics and morphological analyses performed on induced pluripotent stem cell (iPSC)-derived neural cells would improve diagnosis of ID. The current proposal is therefore a proof-of concept project aiming at assessing the relevance and effectiveness of this multi-omics approach.

Aims and Methods Ten individuals with ID recruited through HUGODIMS, in whom WES have failed to identify pathogenic variants will be included.

The workflow is the following:

Whole genome sequencing (WGS) (Nantes) of these 10 negative trios.
Bio-informatics analyses

In 3 WGS negative cases, 3 positive controls bearing distinct mutations in CAMK2a (a novel ID gene identified thanks to HUGODIMS), and 3 healthy negative controls:

Derivation of induced pluripotent stem cell (iPSC)-derived neural progenitors (iPSC core facility at Nantes)
Targeted and non-targeted metabolomics analyses performed on iPSC-derived neuronal cells (Angers)
RNA sequencing performed on the 9 cell lines (Rennes)
Morphological analyses of differentiated neuronal cell lines derived from 3 affected individuals and 3 positive controls bearing CMK2a mutations (Tours)
Integration and validation of data from multi-omics and morphological approaches

Expected results and impact Investigatrors expect that this approach combining multi-omics and iPSC will help to improve diagnosis and understanding of genetic ID of unknown cause

lead_sponsor: University Hospital, Angers

location_facility:
CHU Nantes
CHU de Bourgogne
CHU Poitiers
CHU Angers
HCL Lyon
CHU Rennes


title: Universal Haplotype-Based Non Invasive Prenatal Diagnosis by Linked-Read Sequencing (10XGenomics™ Technology)

acronym: NID

summary:
Description of the presence of cell-free fetal DNA in maternal plasma allowed the possibility of non-invasive prenatal diagnosis. Whereas detection of paternally-inherited alleles is straightforward and being quickly implemented in routine, detection of maternally-inherited alleles remains challenging.

To date, the main approach that is being developped, called Relative Haplotype Dosage Analysis, relies on the identification of an allelic imbalance between the mother's wild-type and mutant alleles, relative to the fetal's contribution. This approach therefore requires the study of a propositus to identify the morbid haplotype, which is not always possible in the context of an ongoing pregnancy.

In this study, we aim to evaluate the contribution of new technologies, such as linked-read Sequencing, to allow direct identification of parental haplotype in the context of non-invasive prenatal diagnosis.

lead_sponsor: University Hospital, Brest

location_facility:
CHU de Rouen
CHU de Nantes
CHRU de Dijon
CHRU de Brest
CH Saint Brieuc
CHU de Rennes


title: The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.

acronym: REVER

summary:
This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.

For each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse).

Treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center.

Patients will be followed during the 3 cycles of treatment.

lead_sponsor: Institut Claudius Regaud

location_facility:
Clinique Pasteur
Clinique Capio La Croix Du Sud
Centre Hospitalier Auch
Clinique Claude Bernard
Centre Hospitalier de Rodez
IUCT-O


title: Teaching the Basics of Electroencephalography to Critical Care Teams

summary:
Knowledge of the basic fundamental skills of electroencephalography would enable medical and nursing staffs to provide efficient and effective bedside EEG monitoring in critically ill patients.

The aim of this study is to evaluate the ability of a 10-points EEG teaching program to allow bedside caregivers (medical and nursing intensive care unit staff) interpreting EEG in the critical care setting.

ReferenceCitation: Legriel S, Jacq G, Lalloz A, Geri G, Mahaux P, Bruel C, Brochon S, Zuber B, André C, Dervin K, Holleville M, Cariou A. Teaching Important Basic EEG Patterns of Bedside Electroencephalography to Critical Care Staffs: A Prospective Multicenter Study. Neurocrit Care. 2021 Feb;34(1):144-153. doi: 10.1007/s12028-020-01010-5.

lead_sponsor: Ictal Group

location_facility: Medico-Surgical Intensive Care Unit - Ambroise Pare Hospital

location_facility: Medico-Surgical Intensive Care Unit - Saint Joseph Hospital

location_facility: Medical Intensive Care Unit - Cochin Teaching Hospital

location_facility: Intensive Care Unit - Versailles Hospital

location_facility: Department of Anesthesia and Critical Care, Beaujon Hospital


title: Regional Multicenter Study to Evaluate Tolerability and Efficacy of TAF/FTC/RPV Combination (ODEFSEY ®) in Prevention of Sexual or Blood Exposure to HIV

acronym: AES ODEFSEY

summary:
Prospective, multicenter study to evaluate tolerability, adherence and efficacy of a 28-day course of TAF/FTC/RPV, an HIV post-exposure prophylaxis after a potential sexual or blood exposure to HIV.

At baseline, participants are prescribed TAF/FTC/RPV and a blood test. At W6, all participants are contacted by phone to evaluate completeness and tolerability of the TAF/FTC/RPV regimen.

location_facility:
Laval Hospital
Saint-Nazaire Hospital
La Roche sur Yon Hospital
Le Mans Hospital
Angers University Hospital
Nantes University Hospital


title: Cohort Study: Modelling Toxicity Processing in Patients Treated by Immunotherapy (MOTIVATE).

acronym: MOTIVATE

summary:
This trial is a multicentric, prospective cohort study of 150 patients aiming to model evolution of toxicity over time in patients with solid tumor and starting first cycle of Immune Checkpoint Inhibitor (ICI) treatment.

The study will be conducted on a population of patients treated with ICI in the context of routine care. The follow-up during the treatment period and the clinical, biological and radiological assessments will be performed according to the standard of each centre.

The study data (immune-related adverse events) will be collected during each administration of the treatment.

A questionnaire will be completed by the patient before the treatment administrations.

Patients will be followed until disease progression or up to 12 months of treatment.

ReferenceCitation: Cabarrou B, Gomez-Roca C, Viala M, Rabeau A, Paulon R, Loirat D, Munsch N, Delord JP, Filleron T. Modernizing adverse events analysis in oncology clinical trials using alternative approaches: rationale and design of the MOTIVATE trial. Invest New Drugs. 2020 Dec;38(6):1879-1887. doi: 10.1007/s10637-020-00938-x. Epub 2020 May 7. Review.

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole

location_facility: Institut Regional Du Cancer de Montpellier (Icm)


title: Third Generation Cognitive Behavioural Therapy Versus Treatment-as-usual for Attention Deficit and Hyperactivity Disorder: a Randomized, 2-parallel-group, Evaluator Blinded, Superiority Trial

acronym: Hyper-mCBT

summary: The investigators hypothesize that the mindfulness Cognitive Behavioral Therapy program will lead to a reduction in attention deficit and hyperactivity disorder symptoms, anxiety and depression, and improve self-confidence, emotional control, social integration and school results.

ReferenceCitation: Crouzet L, Gramond A, Suehs C, Fabbro-Peray P, Abbar M, Lopez-Castroman J. Third-generation cognitive behavioral therapy versus treatment-as-usual for attention deficit and hyperactivity disorder: a multicenter randomized controlled trial. Trials. 2022 Jan 28;23(1):83. doi: 10.1186/s13063-021-05983-2.

location_facility:
Hôpital Pierre Wertheimer
CHU Montpellier
APHP - Hôpital Robert Debré
CH Charles Perrens
APHM - Hôpital Salvator
CHU Nimes

intervention_type: Behavioral


title: Beneficial Effects on Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery on Postoperative Infections

acronym: VECAR

summary: The main objective of this study is to measure the incidence of postoperative infections in 2 groups of patients: one group of patients ventilated and one group of patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery, and demonstrate that the incidence of postoperative infections is significantly lower in patients ventilated during cardiopulmonary bypass.

primary_purpose: Prevention

location_facility:
Hôpital Pitié Salpêtrière
CHU Lille
CHU Angers
CHU Bordeaux
CHU Rennes
CHU Toulouse


title: Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.

summary: Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed. The IgSC prescription will be the decision of the treating physician. Patient care and follow up will be performed according to the current clinical practice and the recommendations of HAS.

ipd_sharing: Undecided

lead_sponsor: Octapharma

location_facility: CHU Bordeaux Centre François Magendie Hopital Haut -Lévêque


title: Induction of Immune-mediated aBscOpal Effect thrOugh STEreotactic Radiation Therapy in Metastatic Melanoma Patients Treated by PD-1 + CTLA-4 Inhibitors (BOOSTER MELANOMA)

summary:
This study is a phase I/II, multicenter, open-label study starting with a phase I part followed by a Phase II part.

The phase I part of the study aims at evaluating the safety and efficacy (in terms of abscopal effect at week 6) of the treatment combination schema of Stereotactic Body Radiation Therapy (SBRT) and PD-1 plus CTLA-4 inhibitors in patients with metastatic melanoma. Patients will be assigned in one of 3 cohorts depending the metastatic site. 18 patients will be enrolled in each cohort.

Once the recommended optimal radiotherapy dose has been declared for the 3 cohorts, patients will be enrolled in the phase II part of the study in order to evaluate the activity (progression-free survival at 6 months) of SBRT given in combination with immune checkpoints inhibitors in patients with metastatic melanoma.

66 patients will be included in the phase II.

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

intervention_type: Combination Product


type: Registry Identifier

title: Prospective Multicenter Evaluation of the MycoGenie Kit for the Diagnosis of Invasive Aspergillosis in Hematological Patients

acronym: MYCOGENIE

summary: The purpose of this study is to evaluate the performances of the real-time PCR ADEMTECH kit of DNA extraction and detection of Aspergillus fumigatus in serum samples in patients at high-risk for invasive aspergillosis (IA). DNA detection will be associated with detection of TR34/L98H mutations in cyp51A gene, which confer azole resistance.

ReferenceCitation: Suarez F, Lortholary O, Buland S, Rubio MT, Ghez D, Mahé V, Quesne G, Poirée S, Buzyn A, Varet B, Berche P, Bougnoux ME. Detection of circulating Aspergillus fumigatus DNA by real-time PCR assay of large serum volumes improves early diagnosis of invasive aspergillosis in high-risk adult patients under hematologic surveillance. J Clin Microbiol. 2008 Nov;46(11):3772-7. doi: 10.1128/JCM.01086-08. Epub 2008 Sep 24.

ReferenceCitation: Dannaoui E, Gabriel F, Gaboyard M, Lagardere G, Audebert L, Quesne G, Godichaud S, Verweij PE, Accoceberry I, Bougnoux ME. Molecular Diagnosis of Invasive Aspergillosis and Detection of Azole Resistance by a Newly Commercialized PCR Kit. J Clin Microbiol. 2017 Nov;55(11):3210-3218. doi: 10.1128/JCM.01032-17. Epub 2017 Aug 16.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital Necker - Enfants maladies (AP-HP)

intervention_type: Diagnostic Test


title: Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine

summary:
Tracheal intubation, particularly before surgery, is traditionally done in supine position. It was shown in the general population and in obese patients in particular, that the pre-oxygenation in a 25° head-up position provided a better efficiency of the pre-oxygenation and an apnea time longer. This position would also allow for better intubation conditions in direct laryngoscopy.

The investigators intend to assess two different patient's intubation position : supine position and 25° head-up position

ReferenceCitation: Falempin AS, Pereira B, Binakdane F, Bazin JE, Smirdec M. Investigator-initiated, multicentre, open-label, two-arm, randomised controlled trial comparing intubating conditions in 25° head-up position and supine: the InSize25 study protocol. BMJ Open. 2019 Nov 3;9(11):e029761. doi: 10.1136/bmjopen-2019-029761.

location_facility:
Hôpital Nord-Ouest
CHU Clermont-Ferrand
Centre Hospitalier Alpes-Léman
Pôle Santé République
Polyclinique Saint Odilon
Hôpital Saint-Louis / AP-HP


title: Impact of the Nurse Visit on Observance of the Intake of Oral Carcinological Treatment

acronym: IPIO-PA

summary: The increasingly used oral anticancer treatments allow the patient to reduce treatment and social constraints to reduce hospitalization costs. The counterpart is a decrease in the monitoring of the correct intake of drugs and the detection of side effects. These two risks are major in the elderly, due to comorbidities, poly-medication and decreased attention. The project objective to evaluate the impact of a bi-weekly nursing visit to the patients' homes for 3 months, compared to a conventional management without a nursing visit. It is a prospective, randomized, controlled, multicenter study to include 224 patients over 18 months. The impact will be assessed by counting the tablets not taken and by filling an observation booklet with the nurse at home.

primary_purpose: Supportive Care

location_facility:
CH Saint Nazaire
CHU de Nantes
ICO Nantes
Hôpital privé du Confluent
CHD Vendée
ICO Angers


title: MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?

summary:
This study concerns elderly patients with cancer with onco-geriatric assessment.

This study propose to associate the collection of the results with the Mini-Cog and the CODEX with the passing of the MoCA and the MMS tests, as well as a neuropsychological assessment, in order to determine if the patients have cognitive impairments, to evaluate the sensitivity of these 4 screening tests in elderly patients seeking treatment for their cancer. The results of this study will make it possible, where appropriate, to adapt the practice in the context of oncogeriatric assessment.

lead_sponsor: Centre Francois Baclesse

location_facility:
Ch Compiegne
Centre Hospitalier
CHU
Centre Henri Becquerel
CH
Centre François Baclesse


title: Effect of a New Formula With a Reduced Concentration of Partially Hydrolyzed Protein on Growth of Healthy Term Infants: an Open-label Study

summary: Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of an existing partially hydrolyzed starter formula, then subsequently fed a partially hydrolyzed follow-up formula over the first year of life.

ReferenceCitation: Billeaud C, Adamon L, Piloquet H, Hays NP, Dupuis L, Metreau I, Léké A. A new partially hydrolyzed whey-based follow-on formula with age-adapted protein content supports healthy growth during the first year of life. Front Pediatr. 2022 Sep 28;10:937882. doi: 10.3389/fped.2022.937882. eCollection 2022.

lead_sponsor: Nestlé

location_facility: CHU Bordeaux - Hôpital Pellegrin Enfants


title: Influence of PARAmedical Interventions on Patient ACTivation in the Cancer Care Pathway

acronym: PARACT

summary: The aim is to implement the Patient Activation Measure in paramedical practices as a tool to measure activation of patients in cancer care

status: Active, not recruiting

ReferenceCitation: Verot E, Bouleftour W, Macron C, Rivoirard R, Chauvin F. Effect of PARACT (PARAmedical Interventions on Patient ACTivation) on the Cancer Care Pathway: Protocol for Implementation of the Patient Activation Measure-13 Item (PAM-13) Version. JMIR Res Protoc. 2020 Dec 8;9(12):e17485. doi: 10.2196/17485.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Clinique de l'infirmerie protestante de Lyon

location_facility: Centre Hospitalier Universitaire de Saint-Etienne


title: Assessment of a Clinical Decision Support System (CADIMS) for Improving Multiple Sclerosis Diagnostic Accuracy

acronym: POCADIMS

summary:
Background The results obtained in clinical research led to a new paradigm for the treatment of patients affected with multiple sclerosis (MS): "no evidence of disease activity". This means having each patient monitored with high quality imaging. To this purpose, researchers have developed segmentation algorithms for automated reading of MRIs, facilitating longitudinal comparisons, and allowing an accurate assessment of the number and the volume of focal lesions. We have thus a powerful strategic biomarker for the treatment of MS.

Due to the relevance of comparing over time the evolution of lesions (lesion load) and brain atrophy, the French Society of Neuroradiology edited standardized national recommendations. The MS French Observatory (OFSEP) has adopted these recommendations, in order to harmonize exams for all patients all over the country. At an international level as well, MRI have been put at the heart of the therapeutic strategy.

Therefore, we need now to create the conditions able to implement, collect and analyze imaging data according to these recommendations.

This is the meaning of the MUSIC project, which aims to develop and assess a standardized monitoring MRI control tool for therapeutic decision.

CADIMS is this tool. It is based on an integration of several segmentation algorithms developed by INRIA and an image viewer developed by b<>com and included in a regional images-sharing server ETIAM Nexus. This tool is a help showing segmented brain T2 lesions, gadolinium-enhanced T1 lesions and news T2 lesions appeared from the previous MRI exam, in a multicenter clinical context.

Objective To evaluate the accuracy of MS lesions detection on cerebral MRI by comparing the CADIMS tool to the expert consensus.

location_facility: Centre Hospitalier Régional et Universitaire de Brest

location_facility: Centre d'imagerie médicale de la découverte

location_facility: Centre Hospitalier Universitaire de Rennes


title: REmote Ischemic COnditioning in Septic Shock: The RECO-Sepsis Study

acronym: RECO-Sepsis

summary:
Septic shock remains a major public health problem in industrialized countries, with a mortality rate as high as 50%, largely related to multiple organ dysfunction. In addition to dysregulated inflammatory response, the pathophysiology of organ failures in septic shock involves ischemia-reperfusion processes. Remote ischemic conditioning is a therapeutic strategy for protecting organs against the detrimental effects of ischemia-reperfusion injury.

The objective of the present study is to determine whether remote ischemic conditioning can limit the severity of organ failure in patients with septic shock.

ReferenceCitation: Cour M, Klouche K, Souweine B, Quenot JP, Schwebel C, Perinel S, Amaz C, Buisson M, Ovize M, Mewton N, Argaud L; RECO-Sepsis Trial Investigators. Remote ischemic conditioning in septic shock: the RECO-Sepsis randomized clinical trial. Intensive Care Med. 2022 Nov;48(11):1563-1572. doi: 10.1007/s00134-022-06872-1. Epub 2022 Sep 14.

ReferenceCitation: Cour M, Buisson M, Klouche K, Bouzgarrou R, Schwebel C, Quenot JP, Zeni F, Beuret P, Ovize M, Argaud L. Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial. Trials. 2019 May 22;20(1):281. doi: 10.1186/s13063-019-3406-4.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Hôpital Edouard Herriot
CHU de Grenoble
CHU de Clermont-Ferrand
CHU de Saint-Etienne
CHU de Montpellier
CH de Roanne


title: Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse

acronym: SAPPRO

summary: The investigators anticipate a reduced risk of post-operational de novo stress urinary incontinence following surgery for vaginal sacrospinofixation, associated with reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and rate of dyspareunia with the new treatment

location_facility:
CHU de clermont-Ferrand
HFME - Hospices Civils de Lyon
Clinique Beau-Soleil
CHU de Lille
CHU Nimes
CHU de Montpellier


title: STEP: Proglide® Versus Femoseal®: A Randomized Controlled Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures

acronym: STEP

summary:
Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. These devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures.

However, main arterial closure devices use different technology to close the arterial puncture point. For some, hemostasis is achieved by sealing the arteriotomy between two discs (an inner and an outer). For others, they are designed to close puncture sites delivering a single monofilament polypropylene suture mediated by needles.

The investigators hypothesis is based on a different efficacy between both arterial closure devices for peripheral arterial disease (PAD) patients.

ReferenceCitation: Gouëffic Y, Picquet J, Schneider F, Kaladji A, Marret O, Muller L, Guyomarc'h B, Riche VP, Chaillou P, Guillou M, Nasr B. A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization. Cardiovasc Intervent Radiol. 2021 Dec;44(12):1883-1892. doi: 10.1007/s00270-021-02940-z. Epub 2021 Aug 13.

lead_sponsor: Nantes University Hospital

location_facility:
CH de Cholet
CHD La Roche-sur-Yon
CHU Angers
CHU Brest
CHU de Poitiers
CHU de Rennes


title: Evaluation of a New Organization for Collecting Pre-chemotherapy Session Information: a Multicenter, Open, Randomized Trial

acronym: ChimioPal

summary: The primary objective of this study is to compare an experimental organization for chemotherapy session planning based on early, standardized, and prioritized means of data transmission via secure e-mail (laboratory results) and the use of a smart phone (for clinical toxicity data) compared to the regular organization, in terms of the rate of prescriptions of chemotherapy prepared at the latest the day before a session and then administered in full (over a 6-month observation period) among colorectal cancer patients in need of cancer treatment in an outpatient setting.

study_start_date_type: Anticipated

status: Withdrawn

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Strasbourg - Hôpital de Hautepierre


title: A Multicenter Clinical Trial To Assess The Efficacy Of Antenatal Maternal Supplementation With GOS/Inulin Prebiotics On Atopic Dermatitis Prevalence In High-Risk One-Year-Old Children.

acronym: PREGRALL

summary: Allergies are increasing worldwide affecting 30-40% of the population. Among this, Atopic Dermatitis (AD) is the earliest and the most common manifestation of allergic diseases (prevalence 20%). Recent studies have shown that allergies were associated with a disruption of the gut microbial 'balance' suggesting that the use of nutritional intervention very early in life may restore an optimal pattern of microflora aiming at improving the host's health. So far, most human intervention studies have mainly focused on improving postnatal infant colonization. Our study will test the hypothesis that a maternal antenatal prebiotics (GOS/inulin) supplementation may be superior to placebo for AD prevention in high-risk children.

ReferenceCitation: Cabridain C, Aubert H, Kaeffer B, Badon V, Boivin M, Dochez V, Winer N, Faurel-Paul E, Planche L, Riochet D, Maruani A, Perrotin F, Droitcourt C, Lassel L, Tching-Sin M, Rogers NK, Bodinier M, Barbarot S. Effectiveness of an antenatal maternal supplementation with prebiotics for preventing atopic dermatitis in high-risk children (the PREGRALL study): protocol for a randomised controlled trial. BMJ Open. 2019 Apr 20;9(4):e024974. doi: 10.1136/bmjopen-2018-024974.

location_facility:
CHU Nantes
University Hospital
Centre Hospitalo Universitaire
CHU Angers
CHD Vendée

intervention_type: Dietary Supplement


title: Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

acronym: ERHEA

summary:
Life expectancy of haemophilia patients (specially severe) has dramatically increase in the last decades, which lead to the apparition of aging diseases such as cardiovascular disease, with the potential bleeding risk of antiplatelet therapies and anticoagulants.

The primary endpoint of the study is to evaluate this bleeding risk in haemophilia patients (all severity) with such treatment in comparison to non treated patients, according to the number of bleeding events in the last year reported by the haemophilia patients under study treatment (antiplatelet and anticoagulant) in comparison to haemophilia patients free of such treatment. The main hypothesis is that antiplatelet and anticoagulant therapy can be safely used in minor haemophilia patients but might lead to increase bleeding risk in other haemophilia patients.

Secondary endpoint consist in:

Evaluate the impact of know cardio-vascular risk in haemophilia patients (Odd ratios=OR)
Evaluate the number of sever bleeding event in patient under study treatments compared to the control group
Evaluate the overall consumption of factor VIII or IX supply in patients under study treatments compared to control group
Estimate the stenosis relapse risk in haemophilia patients with arterial STENT
Estimate the embolic risk of haemophilia patients with atrial fibrillation

Population description:

Haemophilia patients (man, all severity)

Age above 50 years, followed during the last 5 years in one of the study centre

ReferenceCitation: Desjonqueres A, Guillet B, Beurrier P, Pan-Petesch B, Ardillon L, Pineau-Vincent F, Sigaud M, Fouassier M, Ternisien C, Gillet B, Béné MC, Horvais V, Lienhart A, Trossaërt M. Bleeding risk for patients with haemophilia under antithrombotic therapy. Results of the French multicentric study ERHEA. Br J Haematol. 2019 May;185(4):764-767. doi: 10.1111/bjh.15606. Epub 2018 Oct 18.

location_facility:
Tours University Hospital
Brest University Hospital
Rennes University Hospital
Le Mans Hospital
Lyon University Hospital
Angers University Hospital


title: A Phase II Trial of Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias (GTN)

acronym: TROPHIMMUN

summary:
Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a complete hydatidiform mole. GTN patients are commonly treated with single agent treatment (methotrexate or actinomycine-D) or polychemotherapy (first line treatment EMA-CO) according to the predicted risk of resistance to single agent treatment by FIGO score. GTN patients with resistance to these treatments are treated with another single agent drug or polychemotherapy regimens.

Chemotherapy standard regimens are old and toxic for these young lady patients, with potential long term effects detrimental for further maternity and quality of life. There is a need for modern targeted agents with better benefit/toxicity profiles.

There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune tolerance is "hijacked" by GTN cell for proliferating :

Spontaneous regressions of metastasic GTN are regularly observed, thereby the role of immune system for rejecting GTN cells.
Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes and settings of GTN tumors from French reference gestational trophoblastic center.
The case of complete and durable response to pembrolizumab was reported in a patient with multi chemo-resistant GTN.

ReferenceCitation: You B, Bolze PA, Lotz JP, Massardier J, Gladieff L, Joly F, Hajri T, Maucort-Boulch D, Bin S, Rousset P, Devouassoux-Shisheboran M, Roux A, Alves-Ferreira M, Grazziotin-Soares D, Langlois-Jacques C, Mercier C, Villeneuve L, Freyer G, Golfier F. Avelumab in Patients With Gestational Trophoblastic Tumors With Resistance to Single-Agent Chemotherapy: Cohort A of the TROPHIMMUN Phase II Trial. J Clin Oncol. 2020 Sep 20;38(27):3129-3137. doi: 10.1200/JCO.20.00803. Epub 2020 Jul 27.

location_facility: Institut Universitaire Du Cancer de Toulouse - Oncopole


title: Validation of an Allergic Rhinitis Control Test in Children

acronym: ARCTEnfants

summary: Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in teenagers or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5 to 11 years old.

lead_sponsor: University Hospital, Montpellier

location_facility:
Maison de santé de Lasalle
Centre (Ctre) Medical Ravas - Malbosc
CH de MILLAU
Hôpital Trousseau,
CH Louis Pasteur
University hospital of Montpellier


title: Place of Comprehensive Geriatric Assessment (CGA) in Patients ≥ 75 Years Care, With Breast Cancer, After Screening With FOG (Oncology Geriatric Filter): Comparison Between CGA Before Surgery (Strategy A) vs. After Surgery (Strategy B)

summary:
The risk of diagnosis of cancer increases with age, especially breast cancer in elderly women. Elderly population is heterogeneous, regarding physiological reserves, comorbidities, disability and geriatric conditions. Comprehensive geriatric assessment (CGA) is a multidimensional approach to determine geriatric profile, in helping the therapeutic strategy. In-patients with diagnosis of cancer are screened with the FOG (oncology geriatric filter), to identify vulnerable subjects who may benefit from CGA. This scale of ten questions includes geriatric domains such as functional status, nutrition, mood, cognitive abilities and comorbidities. In elderly patients with breast cancer considered as fit (FOG=0), CGA is not necessary before adjuvant treatment. In vulnerable patients (FOG ≤ 1 and < 3), CGA is held in routine to discuss the adjuvant therapy feasibility. Patients with FOG ≥ 4 underwent CGA if palliative care is considered.

Patients in the intermediate group (FOG 1-3) are randomized to determine time of CGA, before or after surgery.

The aims of this study are to assess the outcomes regarding the time of CGA, in elderly female patients with breast cancer management, and to define the optimal place of CGA in care pathway.

lead_sponsor: Poitiers University Hospital

location_facility:
Hospital center
Hospital Center
University Hospital Center


title: Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer

acronym: Rexochir

summary: This randomized controlled trial will evaluate the effect of a preoperative rehabilitation program at home in patients resected for lung cancer, comparing a control group (C group) receiving only chest physiotherapy and a rehabilitation group (R group) receiving both a training program at home and chest physiotherapy

ReferenceCitation: Laurent H, Galvaing G, Thivat E, Coudeyre E, Aubreton S, Richard R, Kwiatkowski F, Costes F, Filaire M. Effect of an intensive 3-week preoperative home rehabilitation programme in patients with chronic obstructive pulmonary disease eligible for lung cancer surgery: a multicentre randomised controlled trial. BMJ Open. 2017 Nov 12;7(11):e017307. doi: 10.1136/bmjopen-2017-017307.

lead_sponsor: Centre Jean Perrin

location_facility: Hospices Civiles de Lyon, groupement hospitalier Est, Hopital Louis Pradel

location_facility: Centre de Recherche en Nutrition Humaine

location_facility: CHU Clermont Ferrand, Gabriel Montpied, service de médecine du sport et explorations fonctionnelles,


summary: The purpose of this study is to determine whether Teleconsultation would a)be effective and cost-effective by increasing the proportion of patients with Autism Spectrum Disorders having a correct follow-up, and less transportation, and b) get a high satisfaction from the parents and from the professionals

time_perspective: Retrospective

location_facility:
IME Le Reverdi
IME Eclair
Hôpital Sainte Anne
Association UNI-TEDS
IME notre Ecole
Association Agir et Vivre l'Autisme


ipd_sharing: Yes

acronym: PANIRINOX

title: Phase II Randomized Study Comparing FOLFIRINOX + Panitumumab Versus mFOLFOX6 + Panitumumab in Metastatic Colorectal Cancer Patients Selected by RAS and B-RAF Status From Circulating DNA Analysis

lead_sponsor: UNICANCER

type: EudraCT Number

source: euctr

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

location_facility: CHU Carémeau - Institut de Cancérologie du Gard

summary:
National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis.

Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.


title: Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants

acronym: CACAOD

summary:
This is a prospective, multicentric, randomized, open labeled superiority trial

This study aims to evaluate the efficacy of oral activated charcoal for improving elimination of direct oral anticoagulants ( Rivaroxaban, Apixaban) in case of an unscheduled invasive procedure delayed to this anticoagulant treatment.

The primary outcome is the anticoagulant's half life. Plasma concentration will be measured by liquid chromatography-mass spectrometry for the main analysis (pharmacokinetic).

A total of 140 patients will randomly be assigned to the charcoal or control group, stratified according to their anticoagulant drug.

location_facility:
CHU Clermont-ferrand
CHU de St Etienne
CHU de Poitiers
CH Le MANS
Chu Angers


title: Tinnitus Treatment With Cochlear Implant in Single Sided Deafness

summary: Recent studies have reported successful reduction of tinnitus after cochlear implantation (CI) in most CI users, but the mechanisms of reduction and the amount of improvement is not fully understood. Especially, the relative role of peripheral and central auditory pathways is not clearly known. This study assessed the effect of CI electrical stimulation on tinnitus in subjects with unilateral tinnitus related to a single-sided deafness (SSD), and relative contributions of peripheral and central auditory pathways in tinnitus reduction.

lead_sponsor: Oticon Medical

location_facility:
CHRU Lille Hôpital Roger Salengro
Hôpital Rothschild
CHU Tours Bretonneau
CHU Rennes Pontchaillou
Hôpital la Pitié Salpêtrièr
CHU Lyon Hôpital Edouard Herriot


title: Evaluation in Real Life Conditions of Sacubitril-valsartan Combination in Patients With Chronic Heart Failure and Sleep Apnea Syndrome

summary:
Chronic Heart Failure (CHF) is a frequent pathology burdened with mortality and significant morbidity. Sleep apnea syndrome (SAS) is frequently associated with CHF in 20% to 75% of cases. Treatment of SAS is however inconsistently associated with a decline in the morbidity and mortality. To date, the CHF medical treatments have been reported to be inconsistently efficient in the treatment of SAS.

SACUBITRIL-VALSARTAN (ENTRESTO®) is a new treatment of CHF recently indicated class I, level B in the recent European Society of Cardiology (ESC) guidelines 2016 on CHF. PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with SACUBITRIL-VALSARTAN. In comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalisation for CHF by 20% with a 16% reduction in all-cause mortality.

The purpose of the research is the evaluation of SACUBITRIL-VALSARTAN combination in CHF patients presenting sleep apnea syndrome. A three months real life observational trial is performed. A measure of the Apnea Hypopnea Index is realised before and after 3 months of SACUBITRIL-VALSARTAN treatment. A concomitant evaluation of cardiological and quality of life parameters is realized.

ReferenceCitation: Jaffuel D, Molinari N, Berdague P, Pathak A, Galinier M, Dupuis M, Ricci JE, Mallet JP, Bourdin A, Roubille F. Impact of sacubitril-valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO-SAS study design. ESC Heart Fail. 2018 Jun;5(3):222-230. doi: 10.1002/ehf2.12270. Epub 2018 Feb 22.

ReferenceType: result

ReferenceCitation: Jaffuel D, Nogue E, Berdague P, Galinier M, Fournier P, Dupuis M, Georger F, Cadars MP, Ricci JE, Plouvier N, Picard F, Puel V, Mallet JP, Suehs CM, Molinari N, Bourdin A, Roubille F. Sacubitril-valsartan initiation in chronic heart failure patients impacts sleep apnea: the ENTRESTO-SAS study. ESC Heart Fail. 2021 Aug;8(4):2513-2526. doi: 10.1002/ehf2.13455. Epub 2021 Jun 8.

location_facility: Centre Hospitalier Universitaire de Montpellier


type: Other Grant/Funding Number

title: Assessment of the Prevalence and Severity of Urinary and Ano-rectal Functional Disorders and Their Impact on Quality of Life and Sexuality on CF Adults of the North-West CF Network

acronym: PerineoMuco

summary: This observational study evaluates prevalence of functional perinea disorders (stress urinary incontinence, overactive bladder syndrome, dysuria, anal incontinence) on CF adults patients of the North-West CF Network. Its aims are to measure the severity of urinary and anorectal symptoms ; assess their impact on patients' quality of life, sexuality, care and social life and relationships ; identify the medical and demographic factors associated with the severity of urinary and anorectal disorders and their impact and determine the relationship between the severity of these disorders, various repercussions, and risk factors.

lead_sponsor: Fondation Ildys

location_facility: CF Center - Groupe Hospitalier Sud Réunion

location_facility: CF Center - Fondation Ildys Site de Perharidy


title: Benefits Evaluation of Selfia® Adapted Underwear for Multiple Sclerosis Patients With Severe to Moderate Handicap Performing Self-catheterization : a Multicenter, Prospective, Uncontrolled and Before/After Study.

acronym: KML

summary:
KML is a multicenter, prospective, uncontrolled and before/after study. The study aims to estimate if the use of Selfia ® adapted underwear reduces the necessary duration for the realization of self-catheterisation (SC) for patients affected by multiple sclerosis with severe to moderate disability.

Secondly, the study aims to :

Estimate the effect of underwear on quality of life, tiredness linked to the act, comfort in the realization of SC, complications with SC, third party intervention ;
Collect patients' opinion on the use of the underwear SELFIA ® at the end of the 2nd week of evaluation ;
Measure if the patient reused underwear and if he bought it at 6 months and at 1 year

lead_sponsor: Lille Catholic University

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille


title: Efficacy of Antibiotic (Tobramycin) Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients: A Multicenter Double-blind Randomized Controlled Trial

acronym: AVASMUC

summary: Patients with cystic fibrosis frequently develop chronic rhinosinusitis. Bacterial colonization is facilitated by a reduced mucociliary function and some previous studies suggest that the microbiology of the upper airways might influence the microbiology of the lower airway. The aim of this randomized control study is to demonstrate efficacy of antibiotic delivered by nebulized sonic aerosol therapy to decrease the bacterial load in sinuses and medium ostia and to improve the sino-nasal symptoms and endoscopic scores, quality of life and lung function

ReferenceCitation: Aanaes K, von Buchwald C, Hjuler T, Skov M, Alanin M, Johansen HK. The effect of sinus surgery with intensive follow-up on pathogenic sinus bacteria in patients with cystic fibrosis. Am J Rhinol Allergy. 2013 Jan;27(1):e1-4. doi: 10.2500/ajra.2013.27.3829.

ReferenceCitation: Berkhout MC, Rijntjes E, El Bouazzaoui LH, Fokkens WJ, Brimicombe RW, Heijerman HG. Importance of bacteriology in upper airways of patients with Cystic Fibrosis. J Cyst Fibros. 2013 Sep;12(5):525-9. doi: 10.1016/j.jcf.2013.01.002. Epub 2013 Jan 26.

ReferenceCitation: Boucher RC. Human airway ion transport. Part one. Am J Respir Crit Care Med. 1994 Jul;150(1):271-81. Review.

ReferenceCitation: Boucher RC. Human airway ion transport. Part two. Am J Respir Crit Care Med. 1994 Aug;150(2):581-93. Review.

ReferenceCitation: Coste A, Gilain L, Roger G, Sebbagh G, Lenoir G, Manach Y, Peynegre R. Endoscopic and CT-scan evaluation of rhinosinusitis in cystic fibrosis. Rhinology. 1995 Sep;33(3):152-6.

ReferenceCitation: Digoy GP, Dunn JD, Stoner JA, Christie A, Jones DT. Bacteriology of the paranasal sinuses in pediatric cystic fibrosis patients. Int J Pediatr Otorhinolaryngol. 2012 Jul;76(7):934-8. doi: 10.1016/j.ijporl.2012.02.043. Epub 2012 Apr 17.

ReferenceCitation: Durand M, Pourchez J, Aubert G, Le Guellec S, Navarro L, Forest V, Rusch P, Cottier M. Impact of acoustic airflow nebulization on intrasinus drug deposition of a human plastinated nasal cast: new insights into the mechanisms involved. Int J Pharm. 2011 Dec 12;421(1):63-71. doi: 10.1016/j.ijpharm.2011.09.023. Epub 2011 Sep 21.

ReferenceCitation: Durand M, Le Guellec S, Pourchez J, Dubois F, Aubert G, Chantrel G, Vecellio L, Hupin C, De Gersem R, Reychler G, Pitance L, Diot P, Jamar F. Sonic aerosol therapy to target maxillary sinuses. Eur Ann Otorhinolaryngol Head Neck Dis. 2012 Oct;129(5):244-50. doi: 10.1016/j.anorl.2011.09.002. Epub 2012 Aug 24.

ReferenceCitation: Gysin C, Alothman GA, Papsin BC. Sinonasal disease in cystic fibrosis: clinical characteristics, diagnosis, and management. Pediatr Pulmonol. 2000 Dec;30(6):481-9. Review.

ReferenceCitation: Hansen SK, Rau MH, Johansen HK, Ciofu O, Jelsbak L, Yang L, Folkesson A, Jarmer HØ, Aanæs K, von Buchwald C, Høiby N, Molin S. Evolution and diversification of Pseudomonas aeruginosa in the paranasal sinuses of cystic fibrosis children have implications for chronic lung infection. ISME J. 2012 Jan;6(1):31-45. doi: 10.1038/ismej.2011.83. Epub 2011 Jun 30.

ReferenceCitation: Kahl BC, Duebbers A, Lubritz G, Haeberle J, Koch HG, Ritzerfeld B, Reilly M, Harms E, Proctor RA, Herrmann M, Peters G. Population dynamics of persistent Staphylococcus aureus isolated from the airways of cystic fibrosis patients during a 6-year prospective study. J Clin Microbiol. 2003 Sep;41(9):4424-7.

ReferenceCitation: Knowles MR, Robinson JM, Wood RE, Pue CA, Mentz WM, Wager GC, Gatzy JT, Boucher RC. Ion composition of airway surface liquid of patients with cystic fibrosis as compared with normal and disease-control subjects. J Clin Invest. 1997 Nov 15;100(10):2588-95. Erratum in: J Clin Invest 1998 Jan 1;101(1):285.

ReferenceCitation: Konstan MW, Morgan WJ, Butler SM, Pasta DJ, Craib ML, Silva SJ, Stokes DC, Wohl ME, Wagener JS, Regelmann WE, Johnson CA; Scientific Advisory Group and the Investigators and Coordinators of the Epidemiologic Study of Cystic Fibrosis. Risk factors for rate of decline in forced expiratory volume in one second in children and adolescents with cystic fibrosis. J Pediatr. 2007 Aug;151(2):134-9, 139.e1. Epub 2007 Jun 22.

ReferenceCitation: Mainz JG, Naehrlich L, Schien M, Käding M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tümmler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.

ReferenceCitation: Ramsey BW, Dorkin HL, Eisenberg JD, Gibson RL, Harwood IR, Kravitz RM, Schidlow DV, Wilmott RW, Astley SJ, McBurnie MA, et al. Efficacy of aerosolized tobramycin in patients with cystic fibrosis. N Engl J Med. 1993 Jun 17;328(24):1740-6.

ReferenceCitation: Regnis JA, Robinson M, Bailey DL, Cook P, Hooper P, Chan HK, Gonda I, Bautovich G, Bye PT. Mucociliary clearance in patients with cystic fibrosis and in normal subjects. Am J Respir Crit Care Med. 1994 Jul;150(1):66-71.

ReferenceCitation: Robertson JM, Friedman EM, Rubin BK. Nasal and sinus disease in cystic fibrosis. Paediatr Respir Rev. 2008 Sep;9(3):213-9. doi: 10.1016/j.prrv.2008.04.003. Epub 2008 Jul 31. Review.

ReferenceCitation: Vaughan WC, Carvalho G. Use of nebulized antibiotics for acute infections in chronic sinusitis. Otolaryngol Head Neck Surg. 2002 Dec;127(6):558-68.

ReferenceCitation: Walter S, Gudowius P, Bosshammer J, Römling U, Weissbrodt H, Schürmann W, von der Hardt H, Tümmler B. Epidemiology of chronic Pseudomonas aeruginosa infections in the airways of lung transplant recipients with cystic fibrosis. Thorax. 1997 Apr;52(4):318-21.

ReferenceCitation: Karanth TK, Karanth VKLK, Ward BK, Woodworth BA, Karanth L. Medical interventions for chronic rhinosinusitis in cystic fibrosis. Cochrane Database Syst Rev. 2022 Apr 7;4:CD012979. doi: 10.1002/14651858.CD012979.pub3. Review.

lead_sponsor: Virginie ESCABASSE

location_facility: Centre Hospitalier Universitaire de la Timone

location_facility: Centre Hospitalier Universitaire De Nantes

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Universitaire de Clermont ferrand


title: Regional Central Database Recording of Chronic Myeloid Leukemia

acronym: LMC

summary: It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (CML) prospectively and retrospectively.

lead_sponsor: Institut Bergonié

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: IPOXA, Phase I/II Dose Escalation Trial Aiming to Evaluate the Safety of Intraperitoneal (IP) OXAliplatin (OXA) in Association With Systemic FOLFIRI Bevacizumab Chemotherapy in Patients With Peritoneal Carcinosis of Colorectal Origin and Uncertain Resectability.

acronym: IPOXA

summary:
Peritoneal carcinosis (PC) corresponds to a locoregional extension into the peritoneum of rare primary peritoneal cancers, or more frequently distant extension of digestive cancers (colorectal or gastric) or gynecological (ovarian, fallopian tube, or endometrial). PC can be considered as a distinct oncological entity as its genesis, natural history, and response to systematic treatments differ to those of other metastases. The development of PC, observed in 25-35% of colorectal cancers, is generally considered as a unfavorable event in the course of the disease. The prognosis is defined by the possibility of complete resection, possibly after neoadjuvant treatment. The benefit provided by the combination of cytoreductive surgery and heated intraperitoneal chemotherapy (HIPEC) with respect to systemic chemotherapy in patients with PC of colorectal origin has been demonstrated based on overall survival in several randomized trials, among which one evaluated oxaliplatin. The evaluation of the clinical benefit-risk related to the repeated administration of non-hyperthermic intraperitoneal chemotherapy, as has been validated in ovarian cancer, in patients with PC of colorectal origin is already being investigated by several international teams.

The FOLFOXIRI + bevacizumab every 2 weeks is a modern therapeutic option in patients with this disease. The intraperitoneal rather than intravenous (IV) administration of oxaliplatin, in this combination, could increase the response of peritoneal lesions known to be relatively insensitive to IV chemotherapy.

location_facility: Service de Chirurgie Digestive et Cancérologique, CHU NORD

location_facility: Département de Chirurgie Cancérologique, Centre Léon Bérard

location_facility: Service Oncologie Médicale, INSTITUT DE CANCEROLOGIE DE LA LOIRE (ICL)

location_facility: Service d'Oncologie Médicale, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud

location_facility: Service de Chirurgie Digestive et de l'Urgence, CHU Albert Michallon


title: Interest of Self-compression Technique on Tolerance of Mammography

acronym: ITACTs

summary:
Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local cancer breast.

It is sometimes poorly tolerated by some patients who complain of an uncomfortable examination or pain.

Breast compression by the manipulator aims to reduce the thickness of the breast during mammography; This act is an important factor of pain or discomfort felt by the patient. But, it is also an image quality factor.

This study aimed to compare self-breast compression by the patient to the compression standard technique carried out by the manipulator.

ReferenceCitation: Henrot P, Boisserie-Lacroix M, Boute V, Troufléau P, Boyer B, Lesanne G, Gillon V, Desandes E, Netter E, Saadate M, Tardivon A, Grentzinger C, Salleron J, Oldrini G. Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial. JAMA Intern Med. 2019 Mar 1;179(3):407-414. doi: 10.1001/jamainternmed.2018.7169.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
Institut Bergonié
Cabinet de radiologie
Polyclinique Majorelle
Institut de Cancérologie de Lorraine
Institut Curie
Centre François Baclesse


title: Open Lung Protective Ventilation During Cardiac Surgery With Cardiopulmonary Bypass : a Randomized Controlled Trial

acronym: PROVECS

summary:
Cardiac surgery with cardiopulmonary bypass (CPB) frequently induces post-operative respiratory dysfunction. The post-operative pulmonary complications (PPCs) significantly increase the peri-operative morbidity and require invasive treatments during longer and more expensive ICU stays. A specific pathophysiology involving general anesthesia and CPB-related factors (inflammation, pulmonary ischemia) has been clearly demonstrated and pulmonary atelectasis seems to play a central role in the occurence of these PPCs. The open lung approach is a ventilation strategy that aims to "open the lung and keep it open" using different ventilatory settings. The efficacy of that strategy is not demonstrated in the global surgical population. However, its application in the perioperative care of cardiac surgery patients could be of great interest by counteracting the development of atelectasis.

The purpose of this multicentre, double blinded, randomized controlled study is to evaluate the influence of a perioperative multimodal protective ventilation strategy based on the "open lung approach" on postoperative outcomes during the first 7 days following cardiac surgery. Participating centres will include 500 adult patients undergoing scheduled on-pump cardiac surgery. The open lung approach will combine recruitment maneuvers (RM), positive end expiratory pressure (PEEP) at 8 cmH2O from intubation to detubation and continuation of ultraprotective ventilation during CPB. It will be compared to a conventional approach without RM, with PEEP at 2 cmH2O and discontinuation of ventilation during CPB. The primary endpoint is any post-operative pulmonary complication. The secondary endpoints are any post-operative extra-pulmonary complications and the number of ICU-free days to day 7.

ReferenceCitation: Lagier D, Fischer F, Fornier W, Huynh TM, Cholley B, Guinard B, Heger B, Quintana G, Villacorta J, Gaillat F, Gomert R, Degirmenci S, Colson P, Lalande M, Benkouiten S, Minh TH, Pozzi M, Collart F, Latremouille C, Vidal Melo MF, Velly LJ, Jaber S, Fellahi JL, Baumstarck K, Guidon C; PROVECS Study Group. Effect of open-lung vs conventional perioperative ventilation strategies on postoperative pulmonary complications after on-pump cardiac surgery: the PROVECS randomized clinical trial. Intensive Care Med. 2019 Oct;45(10):1401-1412. doi: 10.1007/s00134-019-05741-8. Epub 2019 Oct 1.

ReferenceCitation: Lagier D, Fischer F, Fornier W, Fellahi JL, Colson P, Cholley B, Jaber S, Baumstarck K, Guidon C; PROVECS investigators and the ARCOTHOVA group. A perioperative surgeon-controlled open-lung approach versus conventional protective ventilation with low positive end-expiratory pressure in cardiac surgery with cardiopulmonary bypass (PROVECS): study protocol for a randomized controlled trial. Trials. 2018 Nov 13;19(1):624. doi: 10.1186/s13063-018-2967-y.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

location_facility: CHU MontpellierHôpital Arnaud de VILLENEUVE


title: Preliminary Study to the Conception of a Non-invasive Neonatal Monitoring System With Development of a Database

acronym: Digi-NewB

summary: Each year, 300 000 new borns are hospitalised in neonatology units in Europe. This period is very sensitive as newborns are exposed to a high risk of morbidity and mortality, with severe impact on neuro-developmental prognostic. The Rennes University Hospital was granted a specific funding from the European Union in the framework of the Horizon 2020 programme (Call PERSONALISING HEALTH AND CARE 2015-single-stage - Grant Agreement Number 689260) to develop the Digi-NewB project. This project aims to develop innovative non-invasive monitoring tools to support decision making in health. Such tools include a new generation of real time monitoring in neonatology using composite indices made of cardio-respiratory variables, movements, sounds, and clinical data. The Digi-NewB cohort aims to gather all physiological data relevant for the creation of the composite indices.

lead_sponsor: Rennes University Hospital

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


title: Evaluation of Changes in Consumption of Drugs and Substances After Incarceration

acronym: COSMOS

summary: To improve the management and risk reduction, it is essential to understand the evolution of the consumption of psychoactive substances, medicated or not in detention; it does not have at present no data on this subject. This work has as main objective to evaluate the development of substance use terms (goods and consumption practices) by the inmates between the period preceding their incarceration and their fifth month in detention.

location_facility:
Fontenay Le Comte Hospital
Laval Hospital
La Roche sur Yon Hospital
Le Mans Hospital
Angers University Hospital
Nantes University Hospital


title: Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone, for Triple Negative Locally Advanced Breast Cancers and Luminal B Proliferating, Inaccessible to a Conservative Surgery the Outset

summary: In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI

lead_sponsor: University Hospital, Grenoble

location_facility: H. Hartmann Institute of Radiotherapy and Radiosurgery

intervention_type: Radiation


title: Evaluation of the Performance of an e-Health System Comprising Tele-monitoring / Tele-notification and Tele-coaching in Ambulatory Multi-morbid Adult Patients

summary: Prospective, non-randomized, open-label, pilot study conducted in a single group of 30 evaluable patients, i.e. patients completing an approximate 3 month follow-up.

ReferenceCitation: Wilkinson TM, Donaldson GC, Hurst JR, Seemungal TA, Wedzicha JA. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1298-303. Epub 2004 Feb 27.

ReferenceCitation: Conway G. Case management for heart failure in the emergency department. Crit Pathw Cardiol. 2006 Mar;5(1):25-8. doi: 10.1097/01.hpc.0000202240.99184.81.

ReferenceCitation: Elbert NJ, van Os-Medendorp H, van Renselaar W, Ekeland AG, Hakkaart-van Roijen L, Raat H, Nijsten TE, Pasmans SG. Effectiveness and cost-effectiveness of ehealth interventions in somatic diseases: a systematic review of systematic reviews and meta-analyses. J Med Internet Res. 2014 Apr 16;16(4):e110. doi: 10.2196/jmir.2790. Review.

ReferenceCitation: Marcolino MS, Maia JX, Alkmim MB, Boersma E, Ribeiro AL. Telemedicine application in the care of diabetes patients: systematic review and meta-analysis. PLoS One. 2013 Nov 8;8(11):e79246. doi: 10.1371/journal.pone.0079246. eCollection 2013.

ReferenceCitation: Lundell S, Holmner Å, Rehn B, Nyberg A, Wadell K. Telehealthcare in COPD: a systematic review and meta-analysis on physical outcomes and dyspnea. Respir Med. 2015 Jan;109(1):11-26. doi: 10.1016/j.rmed.2014.10.008. Epub 2014 Oct 27. Review.

ReferenceCitation: Cruz J, Brooks D, Marques A. Home telemonitoring effectiveness in COPD: a systematic review. Int J Clin Pract. 2014 Mar;68(3):369-78. doi: 10.1111/ijcp.12345. Epub 2014 Jan 28. Review.

ReferenceCitation: Goldstein RS, O'Hoski S. Telemedicine in COPD: time to pause. Chest. 2014 May;145(5):945-949. doi: 10.1378/chest.13-1656. Review.

ReferenceCitation: Conway A, Inglis SC, Chang AM, Horton-Breshears M, Cleland JG, Clark RA. Not all systematic reviews are systematic: a meta-review of the quality of systematic reviews for non-invasive remote monitoring in heart failure. J Telemed Telecare. 2013 Sep;19(6):326-37. doi: 10.1177/1357633X13503427. Epub 2013 Sep 25. Review.

ReferenceCitation: Nakamura N, Koga T, Iseki H. A meta-analysis of remote patient monitoring for chronic heart failure patients. J Telemed Telecare. 2014 Jan;20(1):11-7. doi: 10.1177/1357633X13517352. Epub 2013 Dec 18. Review.

ReferenceCitation: Purcell R, McInnes S, Halcomb EJ. Telemonitoring can assist in managing cardiovascular disease in primary care: a systematic review of systematic reviews. BMC Fam Pract. 2014 Mar 7;15:43. doi: 10.1186/1471-2296-15-43. Review.

ReferenceCitation: Kitsiou S, Paré G, Jaana M. Effects of home telemonitoring interventions on patients with chronic heart failure: an overview of systematic reviews. J Med Internet Res. 2015 Mar 12;17(3):e63. doi: 10.2196/jmir.4174. Review.

ReferenceCitation: Kotb A, Cameron C, Hsieh S, Wells G. Comparative effectiveness of different forms of telemedicine for individuals with heart failure (HF): a systematic review and network meta-analysis. PLoS One. 2015 Feb 25;10(2):e0118681. doi: 10.1371/journal.pone.0118681. eCollection 2015. Review.

ReferenceCitation: Pandor A, Gomersall T, Stevens JW, Wang J, Al-Mohammad A, Bakhai A, Cleland JG, Cowie MR, Wong R. Remote monitoring after recent hospital discharge in patients with heart failure: a systematic review and network meta-analysis. Heart. 2013 Dec;99(23):1717-26. doi: 10.1136/heartjnl-2013-303811. Epub 2013 May 16. Review.

ReferenceCitation: Feltner C, Jones CD, Cené CW, Zheng ZJ, Sueta CA, Coker-Schwimmer EJ, Arvanitis M, Lohr KN, Middleton JC, Jonas DE. Transitional care interventions to prevent readmissions for persons with heart failure: a systematic review and meta-analysis. Ann Intern Med. 2014 Jun 3;160(11):774-84. doi: 10.7326/M14-0083. Review.

ReferenceCitation: Kitsiou S, Paré G, Jaana M. Systematic reviews and meta-analyses of home telemonitoring interventions for patients with chronic diseases: a critical assessment of their methodological quality. J Med Internet Res. 2013 Jul 23;15(7):e150. doi: 10.2196/jmir.2770. Review. Erratum in: J Med Internet Res. 2013;15(11):e253.

ReferenceCitation: Ekeland AG, Bowes A, Flottorp S. Effectiveness of telemedicine: a systematic review of reviews. Int J Med Inform. 2010 Nov;79(11):736-71. doi: 10.1016/j.ijmedinf.2010.08.006. Review.

ReferenceCitation: Ekeland AG, Bowes A, Flottorp S. Methodologies for assessing telemedicine: a systematic review of reviews. Int J Med Inform. 2012 Jan;81(1):1-11. doi: 10.1016/j.ijmedinf.2011.10.009. Epub 2011 Nov 21. Review.

ReferenceCitation: Conway A, Inglis SC, Clark RA. Effective technologies for noninvasive remote monitoring in heart failure. Telemed J E Health. 2014 Jun;20(6):531-8. doi: 10.1089/tmj.2013.0267. Epub 2014 Apr 14. Review.

ReferenceCitation: Barnett K, Mercer SW, Norbury M, Watt G, Wyke S, Guthrie B. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet. 2012 Jul 7;380(9836):37-43. doi: 10.1016/S0140-6736(12)60240-2. Epub 2012 May 10.

ReferenceCitation: Lefèvre T, d'Ivernois JF, De Andrade V, Crozet C, Lombrail P, Gagnayre R. What do we mean by multimorbidity? An analysis of the literature on multimorbidity measures, associated factors, and impact on health services organization. Rev Epidemiol Sante Publique. 2014 Oct;62(5):305-14. doi: 10.1016/j.respe.2014.09.002. Epub 2014 Oct 25. Review.

ReferenceCitation: Smith SM, Soubhi H, Fortin M, Hudon C, O'Dowd T. Managing patients with multimorbidity: systematic review of interventions in primary care and community settings. BMJ. 2012 Sep 3;345:e5205. doi: 10.1136/bmj.e5205. Review.

ReferenceCitation: Fabbri LM, Boyd C, Boschetto P, Rabe KF, Buist AS, Yawn B, Leff B, Kent DM, Schünemann HJ; ATS/ERS Ad Hoc Committee on Integrating and Coordinating Efforts in COPD Guideline Development. How to integrate multiple comorbidities in guideline development: article 10 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report. Proc Am Thorac Soc. 2012 Dec;9(5):274-81. doi: 10.1513/pats.201208-063ST. Review.

ReferenceCitation: Onder G, Palmer K, Navickas R, Jurevičienė E, Mammarella F, Strandzheva M, Mannucci P, Pecorelli S, Marengoni A; Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS). Time to face the challenge of multimorbidity. A European perspective from the joint action on chronic diseases and promoting healthy ageing across the life cycle (JA-CHRODIS). Eur J Intern Med. 2015 Apr;26(3):157-9. doi: 10.1016/j.ejim.2015.02.020. Epub 2015 Mar 18. Review.

ReferenceCitation: Martín-Lesende I, Orruño E, Bilbao A, Vergara I, Cairo MC, Bayón JC, Reviriego E, Romo MI, Larrañaga J, Asua J, Abad R, Recalde E. Impact of telemonitoring home care patients with heart failure or chronic lung disease from primary care on healthcare resource use (the TELBIL study randomised controlled trial). BMC Health Serv Res. 2013 Mar 28;13:118. doi: 10.1186/1472-6963-13-118.

ReferenceCitation: Sutherland D, Hayter M. Structured review: evaluating the effectiveness of nurse case managers in improving health outcomes in three major chronic diseases. J Clin Nurs. 2009 Nov;18(21):2978-92. doi: 10.1111/j.1365-2702.2009.02900.x. Epub 2009 Sep 11. Review.

ReferenceCitation: Chow SK, Wong FK. A randomized controlled trial of a nurse-led case management programme for hospital-discharged older adults with co-morbidities. J Adv Nurs. 2014 Oct;70(10):2257-71. doi: 10.1111/jan.12375. Epub 2014 Mar 12.

ReferenceCitation: Prochaska JO, DiClemente CC. Transtheorical therapy toward a more integrative model of change. Psychotherapy: Theory, Research and Practice, 1982;19(3):276-287

lead_sponsor: Air Liquide Santé International

location_facility: Cabinet Privé de Cardiologie - 2, rue jean jaurès

location_facility: Centre Hospitalier d'Annecy Genevois - service cardiologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy

location_facility: Cabinet privé de pneumologie - 28 avenue de Genève

location_facility: Centre Hospitalier d'Annecy Genevois - service pneumologie - 1 avenue de l'Hôpital BP 90074 Metz-Tessy

location_facility: cabinet privé de médecine générale - 18, rue Louis Haase

location_facility: Cabinet Privé de Pneumologie - 7 rue gabriel de mortillet


title: Diet and Physical Activity Lifestyle Intervention to Prevent Body Weight Gain in Patients With Type 2 Diabetes Starting Insulin Pump Treatment: a Randomized Controlled Trial

acronym: WeightPump

summary: The purpose of the study is to determine whether a personalized lifestyle intervention focused on diet and physical activity reinforcement is effective in avoiding weight gain in the first months following initiation of subcutaneous insulin pump therapy in type-2 diabetic patients.

lead_sponsor: Icadom

location_facility:
Marseille European Hospital
Annecy-Genevois Hospital
Alpes Léman Hospital
Métropole Savoie Hospital
Grenoble University Hospital
Pierre Oudot Hospital


title: Regional Prospective Multicenter Pilot Study: How to Collect the Expression of Psychological Suffering of Children Under Two Years ?

acronym: RESOPSYBB

summary:
Emotional Neglect (NE) is a form of abuse to the child whose prevalence is high (WHO Europe). Experiencing NE, psycho-emotional development and brain child may be impacted generating psychic suffering signs may progress to severe developmental disorders. The recognition of suffering can prevent and treat these disorders.

This research promotes a multi-professional device, centered on observation, collection of expression of the baby's psychic pain (≤ 2 years) living in vulnerable families. The investigators assume that this collection requires the crossing of looks of a child psychiatrist and a repeated observation at home by a trained nurse.

The two devices described in these two groups are devices set up as part of the routine management of these patients. Usually, depending on the means of structures (human and financial), one of these devices may be preferred over another.

location_facility:
Medical-social Saint-Servan
Medical-social Center Dalby Millet
Medical-Social center Port Boyer
Medical-social center Pilotière
Medical-social St-Etienne de Montluc
Medical-Social center Bellevue


title: A Phase I/II Trial to Assess the Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Recurrent Advanced/Metastatic Endometrial Cancer Patients

acronym: ENDOLA

summary:
Endometrial cancer ranks 11th in terms of incidence (7275 / year) and mortality (2025 deaths/ year). The 5-year overall survivals of patients at diagnosis with locally advanced and metastatic carcinomas are about 50% and 15% respectively. Beyond first line treatment with platinum-based chemotherapy, there is lack of effective drug in this disease, which explains the poor prognosis of patients.

The prognosis of metastatic endometrial cancer patients is poor, and few drugs have been shown to be effective beyond first chemotherapy line.

Endometrial carcinomas are characterized by frequent alterations of PI3K-AKT-mTor; IGF1R and of DNA repair pathways. Phosphatase and tensin homologue (PTEN)-phosphoinositide 3-kinase (PI3K)-mammalian target of rapamycin (mTor) and DNA repair pathways interact, and inhibition of PI3K-AKT-mTor signaling pathway may alter DNA damage repair.

Metronomic cyclophosphamide regimen may increase the anti-proliferative effects of olaparib because it is an alkylating agent, and it exerts anti-angiogenic effects, with a favorable toxicity profile.

Metformin may increase the anti-proliferative effects of olaparib because it downregulates IGF1R and PI3K-AKT-mTor pathways, with no additive toxicity.

lead_sponsor: Hospices Civils de Lyon

location_facility: Comité Gynécologique, Institut Gustave Roussy

location_facility: Service d'Oncologie Médicale, Centre François Baclesse

location_facility: Service d'Oncologie Médicale, Institut Curie

location_facility: Département de Cancérologie Cervico-Faciale et Thoracique, Centre Oscar Lambret

location_facility: Département d'Oncologie Médicale, Centre Antoine Lacassagne


title: Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions - an Open, Multicenter Randomized Controlled Trial With Two Parallel Arms (1:1)

acronym: AVATAR

summary: The main objective of this study is to demonstrate that a single anticoagulant therapy is superior to a combination of anticoagulant and antiplatelet therapy on the net clinical benefit estimated at 12 months after a Transcatheter Aortic Valve Intervention (TAVI) according to BARC2 criteria (bleeding complications; Mehran et al 2011) and VARC2 (other complications; Kappetein et al 2012)..

ReferenceCitation: Girerd X, Radauceanu A, Achard JM, Fourcade J, Tournier B, Brillet G, Silhol F, Hanon O. [Evaluation of patient compliance among hypertensive patients treated by specialists]. Arch Mal Coeur Vaiss. 2001 Aug;94(8):839-42. French.

ReferenceCitation: Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012 Oct;33(19):2403-18. doi: 10.1093/eurheartj/ehs255.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve