title: Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases: Prospective, Randomized, Controlled Study

acronym: METALAP

summary: The objective of this study is to demonstrate the superiority of the laparoscopic approach over the open approach in the resection of colorectal liver metastases, by examining the reduction of postoperative complications (including mortality), measured using the Comprehensive Complication Index (CCI) within 90 days of the procedure or regardless of the date during the hospital stay.

ReferenceCitation: Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.

ReferenceCitation: Manfredi S, Lepage C, Hatem C, Coatmeur O, Faivre J, Bouvier AM. Epidemiology and management of liver metastases from colorectal cancer. Ann Surg. 2006 Aug;244(2):254-9.

ReferenceCitation: Power DG, Kemeny NE. Role of adjuvant therapy after resection of colorectal cancer liver metastases. J Clin Oncol. 2010 May 1;28(13):2300-9. doi: 10.1200/JCO.2009.26.9340. Epub 2010 Apr 5. Review.

ReferenceCitation: Komatsu S, Scatton O, Goumard C, Sepulveda A, Brustia R, Perdigao F, Soubrane O. Development Process and Technical Aspects of Laparoscopic Hepatectomy: Learning Curve Based on 15 Years of Experience. J Am Coll Surg. 2017 May;224(5):841-850. doi: 10.1016/j.jamcollsurg.2016.12.037. Epub 2017 Jan 20.

ReferenceCitation: Fuks D, Cauchy F, Ftériche S, Nomi T, Schwarz L, Dokmak S, Scatton O, Fusco G, Belghiti J, Gayet B, Soubrane O. Laparoscopy Decreases Pulmonary Complications in Patients Undergoing Major Liver Resection: A Propensity Score Analysis. Ann Surg. 2016 Feb;263(2):353-61. doi: 10.1097/SLA.0000000000001140.

ReferenceCitation: Nomi T, Fuks D, Ogiso S, Nakajima Y, Louvet C, Gayet B. Second and Third Laparoscopic Liver Resection for Patients With Recurrent Colorectal Liver Metastases. Ann Surg. 2016 May;263(5):e68-72. doi: 10.1097/SLA.0000000000001528.

ReferenceCitation: Ciria R, Cherqui D, Geller DA, Briceno J, Wakabayashi G. Comparative Short-term Benefits of Laparoscopic Liver Resection: 9000 Cases and Climbing. Ann Surg. 2016 Apr;263(4):761-77. doi: 10.1097/SLA.0000000000001413. Review.

ReferenceCitation: Hallet J, Sa Cunha A, Cherqui D, Gayet B, Goéré D, Bachellier P, Laurent A, Fuks D, Navarro F, Pessaux P; French Colorectal Liver Metastases Working Group, Association Française de Chirurgie. Laparoscopic Compared to Open Repeat Hepatectomy for Colorectal Liver Metastases: a Multi-institutional Propensity-Matched Analysis of Short- and Long-Term Outcomes. World J Surg. 2017 Dec;41(12):3189-3198. doi: 10.1007/s00268-017-4119-z.

ReferenceCitation: Fretland ÅA, Dagenborg VJ, Bjørnelv GMW, Kazaryan AM, Kristiansen R, Fagerland MW, Hausken J, Tønnessen TI, Abildgaard A, Barkhatov L, Yaqub S, Røsok BI, Bjørnbeth BA, Andersen MH, Flatmark K, Aas E, Edwin B. Laparoscopic Versus Open Resection for Colorectal Liver Metastases: The OSLO-COMET Randomized Controlled Trial. Ann Surg. 2018 Feb;267(2):199-207. doi: 10.1097/SLA.0000000000002353.

ReferenceCitation: Gilg S, Sparrelid E, Isaksson B, Lundell L, Nowak G, Strömberg C. Mortality-related risk factors and long-term survival after 4460 liver resections in Sweden-a population-based study. Langenbecks Arch Surg. 2017 Feb;402(1):105-113. doi: 10.1007/s00423-016-1512-2. Epub 2016 Oct 1.

ReferenceCitation: Cannon RM, Scoggins CR, Callender GG, McMasters KM, Martin RC 2nd. Laparoscopic versus open resection of hepatic colorectal metastases. Surgery. 2012 Oct;152(4):567-73; discussion 573-4. doi: 10.1016/j.surg.2012.07.013. Epub 2012 Sep 1.

ReferenceCitation: Beppu T, Wakabayashi G, Hasegawa K, Gotohda N, Mizuguchi T, Takahashi Y, Hirokawa F, Taniai N, Watanabe M, Katou M, Nagano H, Honda G, Baba H, Kokudo N, Konishi M, Hirata K, Yamamoto M, Uchiyama K, Uchida E, Kusachi S, Kubota K, Mori M, Takahashi K, Kikuchi K, Miyata H, Takahara T, Nakamura M, Kaneko H, Yamaue H, Miyazaki M, Takada T. Long-term and perioperative outcomes of laparoscopic versus open liver resection for colorectal liver metastases with propensity score matching: a multi-institutional Japanese study. J Hepatobiliary Pancreat Sci. 2015 Oct;22(10):711-20. doi: 10.1002/jhbp.261. Epub 2015 May 21.

ReferenceCitation: Adam R, Pascal G, Azoulay D, Tanaka K, Castaing D, Bismuth H. Liver resection for colorectal metastases: the third hepatectomy. Ann Surg. 2003 Dec;238(6):871-83; discussion 883-4.

ReferenceCitation: Bonjer HJ, Deijen CL, Haglind E; COLOR II Study Group. A Randomized Trial of Laparoscopic versus Open Surgery for Rectal Cancer. N Engl J Med. 2015 Jul 9;373(2):194. doi: 10.1056/NEJMc1505367.

ReferenceCitation: Farges O, Goutte N, Bendersky N, Falissard B; ACHBT-French Hepatectomy Study Group. Incidence and risks of liver resection: an all-inclusive French nationwide study. Ann Surg. 2012 Nov;256(5):697-704; discussion 704-5. doi: 10.1097/SLA.0b013e31827241d5.

ReferenceCitation: Tranchart H, Dagher I. Laparoscopic liver resection: a review. J Visc Surg. 2014 Apr;151(2):107-15. doi: 10.1016/j.jviscsurg.2013.10.003. Epub 2013 Dec 22. Review.

ReferenceCitation: Vigano L, Laurent A, Tayar C, Tomatis M, Ponti A, Cherqui D. The learning curve in laparoscopic liver resection: improved feasibility and reproducibility. Ann Surg. 2009 Nov;250(5):772-82. doi: 10.1097/SLA.0b013e3181bd93b2.

ReferenceCitation: Castaing D, Vibert E, Ricca L, Azoulay D, Adam R, Gayet B. Oncologic results of laparoscopic versus open hepatectomy for colorectal liver metastases in two specialized centers. Ann Surg. 2009 Nov;250(5):849-55. doi: 10.1097/SLA.0b013e3181bcaf63.

ReferenceCitation: Hasegawa Y, Nitta H, Sasaki A, Takahara T, Itabashi H, Katagiri H, Otsuka K, Nishizuka S, Wakabayashi G. Long-term outcomes of laparoscopic versus open liver resection for liver metastases from colorectal cancer: A comparative analysis of 168 consecutive cases at a single center. Surgery. 2015 Jun;157(6):1065-72. doi: 10.1016/j.surg.2015.01.017. Epub 2015 Mar 16.

ReferenceCitation: Karagkounis G, Akyuz M, Guerron AD, Yazici P, Aucejo FN, Quintini C, Miller CM, Vogt DP, Fung JJ, Berber E. Perioperative and oncologic outcomes of minimally invasive liver resection for colorectal metastases: A case-control study of 130 patients. Surgery. 2016 Oct;160(4):1097-1103. doi: 10.1016/j.surg.2016.04.043. Epub 2016 Jul 30.

ReferenceCitation: Schiffman SC, Kim KH, Tsung A, Marsh JW, Geller DA. Laparoscopic versus open liver resection for metastatic colorectal cancer: a metaanalysis of 610 patients. Surgery. 2015 Feb;157(2):211-22. doi: 10.1016/j.surg.2014.08.036. Epub 2014 Oct 1.

ReferenceCitation: Tohme S, Goswami J, Han K, Chidi AP, Geller DA, Reddy S, Gleisner A, Tsung A. Minimally Invasive Resection of Colorectal Cancer Liver Metastases Leads to an Earlier Initiation of Chemotherapy Compared to Open Surgery. J Gastrointest Surg. 2015 Dec;19(12):2199-206. doi: 10.1007/s11605-015-2962-5. Epub 2015 Oct 5.

ReferenceCitation: Topal H, Tiek J, Aerts R, Topal B. Outcome of laparoscopic major liver resection for colorectal metastases. Surg Endosc. 2012 Sep;26(9):2451-5. doi: 10.1007/s00464-012-2209-4. Epub 2012 Feb 23.

ReferenceCitation: Polignano FM, Quyn AJ, Sanjay P, Henderson NA, Tait IS. Totally laparoscopic strategies for the management of colorectal cancer with synchronous liver metastasis. Surg Endosc. 2012 Sep;26(9):2571-8. doi: 10.1007/s00464-012-2235-2. Epub 2012 Mar 22.

ReferenceCitation: Vanounou T, Steel JL, Nguyen KT, Tsung A, Marsh JW, Geller DA, Gamblin TC. Comparing the clinical and economic impact of laparoscopic versus open liver resection. Ann Surg Oncol. 2010 Apr;17(4):998-1009. doi: 10.1245/s10434-009-0839-0. Epub 2009 Dec 22.

ReferenceCitation: Wakabayashi G, Cherqui D, Geller DA, Han HS, Kaneko H, Buell JF. Laparoscopic hepatectomy is theoretically better than open hepatectomy: preparing for the 2nd International Consensus Conference on Laparoscopic Liver Resection. J Hepatobiliary Pancreat Sci. 2014 Oct;21(10):723-31. doi: 10.1002/jhbp.139. Epub 2014 Aug 5.

ReferenceCitation: Kazaryan AM, Marangos IP, Røsok BI, Rosseland AR, Villanger O, Fosse E, Mathisen O, Edwin B. Laparoscopic resection of colorectal liver metastases: surgical and long-term oncologic outcome. Ann Surg. 2010 Dec;252(6):1005-12. doi: 10.1097/SLA.0b013e3181f66954.

ReferenceCitation: Makabe K, Nitta H, Takahara T, Hasegawa Y, Kanno S, Nishizuka S, Sasaki A, Wakabayashi G. Efficacy of occlusion of hepatic artery and risk of carbon dioxide gas embolism during laparoscopic hepatectomy in a pig model. J Hepatobiliary Pancreat Sci. 2014 Aug;21(8):592-8. doi: 10.1002/jhbp.103. Epub 2014 Apr 21.

ReferenceCitation: Wu WC, Smith TS, Henderson WG, Eaton CB, Poses RM, Uttley G, Mor V, Sharma SC, Vezeridis M, Khuri SF, Friedmann PD. Operative blood loss, blood transfusion, and 30-day mortality in older patients after major noncardiac surgery. Ann Surg. 2010 Jul;252(1):11-7. doi: 10.1097/SLA.0b013e3181e3e43f.

ReferenceCitation: Karakousis GC, Singer S, Zheng J, Gonen M, Coit D, DeMatteo RP, Strong VE. Laparoscopic versus open gastric resections for primary gastrointestinal stromal tumors (GISTs): a size-matched comparison. Ann Surg Oncol. 2011 Jun;18(6):1599-605. doi: 10.1245/s10434-010-1517-y. Epub 2011 Jan 5.

ReferenceCitation: Pham TH, Perry KA, Dolan JP, Schipper P, Sukumar M, Sheppard BC, Hunter JG. Comparison of perioperative outcomes after combined thoracoscopic-laparoscopic esophagectomy and open Ivor-Lewis esophagectomy. Am J Surg. 2010 May;199(5):594-8. doi: 10.1016/j.amjsurg.2010.01.005.

ReferenceCitation: Nobili C, Marzano E, Oussoultzoglou E, Rosso E, Addeo P, Bachellier P, Jaeck D, Pessaux P. Multivariate analysis of risk factors for pulmonary complications after hepatic resection. Ann Surg. 2012 Mar;255(3):540-50. doi: 10.1097/SLA.0b013e3182485857.

ReferenceCitation: Lawrence VA, Cornell JE, Smetana GW; American College of Physicians. Strategies to reduce postoperative pulmonary complications after noncardiothoracic surgery: systematic review for the American College of Physicians. Ann Intern Med. 2006 Apr 18;144(8):596-608. Review.

ReferenceCitation: Soubrane O, Schwarz L, Cauchy F, Perotto LO, Brustia R, Bernard D, Scatton O. A Conceptual Technique for Laparoscopic Right Hepatectomy Based on Facts and Oncologic Principles: The Caudal Approach. Ann Surg. 2015 Jun;261(6):1226-31. doi: 10.1097/SLA.0000000000000737.

ReferenceCitation: Fretland AA, Sokolov A, Postriganova N, Kazaryan AM, Pischke SE, Nilsson PH, Rognes IN, Bjornbeth BA, Fagerland MW, Mollnes TE, Edwin B. Inflammatory Response After Laparoscopic Versus Open Resection of Colorectal Liver Metastases: Data From the Oslo-CoMet Trial. Medicine (Baltimore). 2015 Oct;94(42):e1786. doi: 10.1097/MD.0000000000001786. Erratum in: Medicine (Baltimore). 2016 Mar;95(10):e367e.

ReferenceCitation: Veenhof AA, Vlug MS, van der Pas MH, Sietses C, van der Peet DL, de Lange-de Klerk ES, Bonjer HJ, Bemelman WA, Cuesta MA. Surgical stress response and postoperative immune function after laparoscopy or open surgery with fast track or standard perioperative care: a randomized trial. Ann Surg. 2012 Feb;255(2):216-21. doi: 10.1097/SLA.0b013e31824336e2.

ReferenceCitation: Qiu J, Chen S, Pankaj P, Wu H. Laparoscopic hepatectomy is associated with considerably less morbidity and a long-term survival similar to that of the open procedure in patients with hepatic colorectal metastases. Surg Laparosc Endosc Percutan Tech. 2014 Dec;24(6):517-22. doi: 10.1097/SLE.0b013e31829cec2b.

ReferenceCitation: Gigot JF, Glineur D, Santiago Azagra J, Goergen M, Ceuterick M, Morino M, Etienne J, Marescaux J, Mutter D, van Krunckelsven L, Descottes B, Valleix D, Lachachi F, Bertrand C, Mansvelt B, Hubens G, Saey JP, Schockmel R; Hepatobiliary and Pancreatic Section of the Royal Belgian Society of Surgery and the Belgian Group for Endoscopic Surgery. Laparoscopic liver resection for malignant liver tumors: preliminary results of a multicenter European study. Ann Surg. 2002 Jul;236(1):90-7.

ReferenceCitation: Okunrintemi V, Gani F, Pawlik TM. National Trends in Postoperative Outcomes and Cost Comparing Minimally Invasive Versus Open Liver and Pancreatic Surgery. J Gastrointest Surg. 2016 Nov;20(11):1836-1843. Epub 2016 Sep 9.

ReferenceCitation: Montalti R, Berardi G, Laurent S, Sebastiani S, Ferdinande L, Libbrecht LJ, Smeets P, Brescia A, Rogiers X, de Hemptinne B, Geboes K, Troisi RI. Laparoscopic liver resection compared to open approach in patients with colorectal liver metastases improves further resectability: Oncological outcomes of a case-control matched-pairs analysis. Eur J Surg Oncol. 2014 May;40(5):536-544. doi: 10.1016/j.ejso.2014.01.005. Epub 2014 Feb 2.

ReferenceCitation: Nachmany I, Pencovich N, Zohar N, Ben-Yehuda A, Binyamin C, Goykhman Y, Lubezky N, Nakache R, Klausner JM. Laparoscopic versus open liver resection for metastatic colorectal cancer. Eur J Surg Oncol. 2015 Dec;41(12):1615-20. doi: 10.1016/j.ejso.2015.09.014. Epub 2015 Sep 30.

ReferenceCitation: Ratti F, Catena M, Di Palo S, Staudacher C, Aldrighetti L. Impact of totally laparoscopic combined management of colorectal cancer with synchronous hepatic metastases on severity of complications: a propensity-score-based analysis. Surg Endosc. 2016 Nov;30(11):4934-4945. Epub 2016 Mar 4.

ReferenceCitation: Allard MA, Cunha AS, Gayet B, Adam R, Goere D, Bachellier P, Azoulay D, Ayav A, Navarro F, Pessaux P; Colorectal Liver Metastases-French Study Group. Early and Long-term Oncological Outcomes After Laparoscopic Resection for Colorectal Liver Metastases: A Propensity Score-based Analysis. Ann Surg. 2015 Nov;262(5):794-802. doi: 10.1097/SLA.0000000000001475.

ReferenceCitation: Cipriani F, Rawashdeh M, Stanton L, Armstrong T, Takhar A, Pearce NW, Primrose J, Abu Hilal M. Propensity score-based analysis of outcomes of laparoscopic versus open liver resection for colorectal metastases. Br J Surg. 2016 Oct;103(11):1504-12. doi: 10.1002/bjs.10211. Epub 2016 Aug 3.

ReferenceCitation: Van Ness P. The concept of risk in biomedical research involving human subjects. Bioethics. 2001 Aug;15(4):364-70.

ReferenceCitation: Tranchart H, Fuks D, Vigano L, Ferretti S, Paye F, Wakabayashi G, Ferrero A, Gayet B, Dagher I. Laparoscopic simultaneous resection of colorectal primary tumor and liver metastases: a propensity score matching analysis. Surg Endosc. 2016 May;30(5):1853-62. doi: 10.1007/s00464-015-4467-4. Epub 2015 Aug 15.

ReferenceCitation: Untereiner X, Cagniet A, Memeo R, Tzedakis S, Piardi T, Severac F, Mutter D, Kianmanesh R, Marescaux J, Sommacale D, Pessaux P. Laparoscopic hepatectomy versus open hepatectomy for colorectal cancer liver metastases: comparative study with propensity score matching. Hepatobiliary Surg Nutr. 2016 Aug;5(4):290-9. doi: 10.21037/hbsn.2015.12.06.

ReferenceCitation: Martínez-Cecilia D, Cipriani F, Shelat V, Ratti F, Tranchart H, Barkhatov L, Tomassini F, Montalti R, Halls M, Troisi RI, Dagher I, Aldrighetti L, Edwin B, Abu Hilal M. Laparoscopic Versus Open Liver Resection for Colorectal Metastases in Elderly and Octogenarian Patients: A Multicenter Propensity Score Based Analysis of Short- and Long-term Outcomes. Ann Surg. 2017 Jun;265(6):1192-1200. doi: 10.1097/SLA.0000000000002147.

ReferenceCitation: Wong-Lun-Hing EM, van Dam RM, van Breukelen GJ, Tanis PJ, Ratti F, van Hillegersberg R, Slooter GD, de Wilt JH, Liem MS, de Boer MT, Klaase JM, Neumann UP, Aldrighetti LA, Dejong CH; ORANGE II Collaborative Group. Randomized clinical trial of open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery after surgery programme (ORANGE II study). Br J Surg. 2017 Apr;104(5):525-535. doi: 10.1002/bjs.10438. Epub 2017 Jan 31.

ReferenceCitation: Elshamy M, Takahashi H, Akyuz M, Yazici P, Yigitbas H, Hammad AY, Aucejo FN, Quintini C, Fung J, Berber E. Evolution of a laparoscopic liver resection program: an analysis of 203 cases. Surg Endosc. 2017 Oct;31(10):4150-4155. doi: 10.1007/s00464-017-5468-2. Epub 2017 Mar 31.

ReferenceCitation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13.

ReferenceCitation: Slankamenac K, Nederlof N, Pessaux P, de Jonge J, Wijnhoven BP, Breitenstein S, Oberkofler CE, Graf R, Puhan MA, Clavien PA. The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials. Ann Surg. 2014 Nov;260(5):757-62; discussion 762-3. doi: 10.1097/SLA.0000000000000948.

ReferenceCitation: Balzan S, Belghiti J, Farges O, Ogata S, Sauvanet A, Delefosse D, Durand F. The "50-50 criteria" on postoperative day 5: an accurate predictor of liver failure and death after hepatectomy. Ann Surg. 2005 Dec;242(6):824-8, discussion 828-9.

ReferenceCitation: Ishizawa T, Hasegawa K, Kokudo N, Sano K, Imamura H, Beck Y, Sugawara Y, Makuuchi M. Risk factors and management of ascites after liver resection to treat hepatocellular carcinoma. Arch Surg. 2009 Jan;144(1):46-51. doi: 10.1001/archsurg.2008.511.

ReferenceCitation: Koch M, Garden OJ, Padbury R, Rahbari NN, Adam R, Capussotti L, Fan ST, Yokoyama Y, Crawford M, Makuuchi M, Christophi C, Banting S, Brooke-Smith M, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Nimura Y, Figueras J, DeMatteo RP, Büchler MW, Weitz J. Bile leakage after hepatobiliary and pancreatic surgery: a definition and grading of severity by the International Study Group of Liver Surgery. Surgery. 2011 May;149(5):680-8. doi: 10.1016/j.surg.2010.12.002. Epub 2011 Feb 12.

ReferenceCitation: Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Am J Infect Control. 1992 Oct;20(5):271-4.

ReferenceCitation: Rahbari NN, Garden OJ, Padbury R, Maddern G, Koch M, Hugh TJ, Fan ST, Nimura Y, Figueras J, Vauthey JN, Rees M, Adam R, Dematteo RP, Greig P, Usatoff V, Banting S, Nagino M, Capussotti L, Yokoyama Y, Brooke-Smith M, Crawford M, Christophi C, Makuuchi M, Büchler MW, Weitz J. Post-hepatectomy haemorrhage: a definition and grading by the International Study Group of Liver Surgery (ISGLS). HPB (Oxford). 2011 Aug;13(8):528-35. doi: 10.1111/j.1477-2574.2011.00319.x. Epub 2011 Jun 7. Review.

ReferenceCitation: Cauchy F, Fuks D, Nomi T, Schwarz L, Barbier L, Dokmak S, Scatton O, Belghiti J, Soubrane O, Gayet B. Risk factors and consequences of conversion in laparoscopic major liver resection. Br J Surg. 2015 Jun;102(7):785-95. doi: 10.1002/bjs.9806. Epub 2015 Apr 2.

ReferenceCitation: Blazeby JM, Fayers P, Conroy T, Sezer O, Ramage J, Rees M; European Organization for Research Treatment of Cancer (EORTC) Quality of Life Group. Validation of the European Organization for Research and Treatment of Cancer QLQ-LMC21 questionnaire for assessment of patient-reported outcomes during treatment of colorectal liver metastases. Br J Surg. 2009 Mar;96(3):291-8. doi: 10.1002/bjs.6471.

ReferenceCitation: Graham JW, Olchowski AE, Gilreath TD. How many imputations are really needed? Some practical clarifications of multiple imputation theory. Prev Sci. 2007 Sep;8(3):206-13. Epub 2007 Jun 5.

lead_sponsor: Institut Mutualiste Montsouris

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil


title: Modalités de Déclenchement Des Patientes Obèses à Terme (MODOBAT)

acronym: MODOBAT

summary: In normal-weight patients, numerous studies show an equivalence of efficacy between dinoprostone and balloon to induce labor. In obese patients, this efficacy is not known, although inductions of labor are more frequent. MODOBAT aims to describe the ability to obtain a vaginal delivery of two modality of induction of labor (vaginal dinoprostone and single balloon Foley catheter) in obese women at term.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Other

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU Besançon
Hopital Nord Franche-Comté

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Haemophilia and Bone Loss PHILEOS Study

acronym: PHILEOS

summary: Haemophilia is a rare bleeding disorder, characterized by factor VIII (HA) or factor IX (HB) deficiency. The absence or the reduction of fVIII or fIX result in impaired thrombin generation and clot formation, causing excessive bleeding (mainly haemarthrosis). Osteoporosis is a systemic bone disease characterized by a low bone mineral density (BMD). A decrease of mean BMD has been described in haemophilic patients compared to healthy controls in several studies. So, osteoporosis could be an underestimated haemophilia-related comorbidity. None of the following risk factors (reduced physical activity, joint damage, vitamin D deficiency and /or hepatitis C virus (HCV) infection) has been retained as a cause of osteoporosis in haemophilic patients. Another hypothesis is that bone loss could be directly linked to fVIII or fIX and/or thrombin deficiency. The aim of this study is to evaluate the prevalence of the bone loss in HA and B patients, according to the type, the severity and the presence (or not) of a prophylactic treatment (depending on the age at which it was began) and to compare it to a control population. The investigators will also evaluate the relation between BMD and FVIII, fIX and thrombin potential.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Screening

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Tardy-Poncet B, Play B, Montmartin A, Damien P, Ollier E, Presles E, Garcin A, Tardy B. PHILEOS (haemoPHILia and ostEoporOSis) Study: protocol of a multicentre prospective case-control study. BMJ Open. 2021 Jan 13;11(1):e042283. doi: 10.1136/bmjopen-2020-042283.

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_country: France Romania Belgium

location_facility: HCL - Groupement Hospitalier Est (Hôpital Louis Pradel)

intervention_type: Radiation

status_simplified: Ongoing


title: Role of a Silicone Prosthesis to Prevent Airway Obstruction Recurrence After Therapeutic Bronchoscopy in Lung Cancers (SPOC Study)

acronym: SPOC

summary:
A tumoral obstruction of the main stem bronchus is frequently observed in the follow-up of lung cancers with a high impact on survival and quality of life of these patients. The endoluminal resection of these tumors through interventional bronchoscopy can remove the tumor but fails to prevent the recurrence. A stent insertion could achieve this goal but this option was never proved in a prospective protocol.

The aim of this study is to analyze the impact of stent insertion on the survival without symptoms of bronchial obstruction in patients treated for their cancer with and without a first line treatment (chemo-radiotherapy or chemotherapy). The patients will be included after resection of the endoluminal symptomatic tumoral obstruction. We will test the effect of the silicone stent insertion ( from NovatechR ) by comparing a stent arm (170 patients with stent insertion) with a control arm (170 patients without stent). The inclusion period will last 3 years with one year of follow-up for each patient. The one-year survival without symptomatic recurrence (proved on bronchoscopy with more than 50% of obstruction in the treated zone) will be the main endpoint. All patients without symptomatic recurrence at one year will be controlled endoscopically. Survival and stent tolerance will be studied as secondary endpoints. All endoscopic events will be depicted on photographs or videos. Each endoscopical situation (before and after resection, recurrence or side effects of stents) will be analyzed and registered by an independent committee of 3 international experts.

status: Terminated

design_allocation: Randomized

primary_purpose: Treatment

location_facility: Pneumology departement CHU Saint-Etienne

location_facility: Pneumology departement, Saint-Antoine hospital

location_facility: Pneumology Clinic - Albert Calmette hospital- CHU Rouen

location_facility: Endoscopy unit, Thoracic surgery department, Foch Hospital

location_facility: Pneumology departement, Sainte Marguerite hospital

location_facility: Department of respiratory diseases and allergic, Thoracic Oncology, CHU Reims

status_simplified: Unknown


title: Prognostic Value of the CINSARC (Complexity Index in Sarcoma) Signature and Correlation With Chemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics )

acronym: NEOSarcomics

summary: This is a prospective observational biomarker study including patients with non-metastatic, soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option by the multidisciplinary sarcoma team of one of the participating centers.

primary_purpose: Other

ipd_sharing: Undecided

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonié
Centre Georges François Leclerc
AP-HM _ Hôpital de la Timone
Institut Paoli Calmettes
Institut Claudius Regaud - IUCT-0
Institut de Cancérologie de l'Ouest
Centre Léon Bérard
Centre Oscar Lambret
Institut Gustave Roussy
Institut Curie

intervention_type: Other

lead_sponsor_type: industriel


title: Effect of High-Dose Quadrivalent Influenza Vaccine (Efluelda®) Versus Standard-Dose (QIV-SD), in Subjects 65 Years of Age and Older on Innate Immunity, Including Gene Expression

acronym: INFLUOMICS

summary: The purpose of the study is to evaluate innate and adaptive immunity following QIV-HD vaccination compared to QIV-SD vaccination in people 65 years of age and older.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Annecy Genevois

location_facility:
Centre Hospitalier Métropole Savoie
Centre Hospitalier Annecy Genevois

intervention_type: Biological


intervention_type: Drug

title: LOC-R01: Randomized Phase IB/II Study of Escalating Doses of Lenalidomide and Ibrutinib in Association With R-MPV as a Targeted Induction Treatment for Patients Aged 18 to 60 (up to 65 for Phase II) With a Newly Diagnosed Primary Central Nervous System Lymphoma

lead_sponsor: Institut Curie

type: EudraCT Number

source: euctr

location_facility:
CHU Besançon
CHU Clermont-Ferrand
CHU Angers
Hôpital Cochin
CHU La Timone Marseille
IUCT -Oncopole
CHU Rennes
CHU Nancy
CHRU Lille
Institut Bergonié
CHU Tours
CHU Poitiers
CHU Grenoble
CHU Créteil
Institut Curie
CHU Nantes
CHU Lyon
Centre Lacassagne
CHU Caen
CHU Limoges
CHU Pitié-Salpêtrière
Centre Henri Becquerel
CHU Amiens
CHU Dijon
CH Colmar

summary: This study is to improve the first-line induction chemotherapy, by combining either Ibrutinib, or Lenalidomide, to a conventional immuno- chemotherapy of R-MPV type (Rituximab-Methotrexate-Procarbazine-Vincristine). This is a randomized Phase II trial, preceded by a dose escalation phase Ib. The objective of the phase Ib is to rule out any limiting toxicity of the new treatment associations, and to determine the recommended dose of Lenalidomide and Ibrutinib to be used in the phase II. In the phase II study, patients will receive 4 cycles of R-MPV + Lenalidomide or 4 cycles of R-MPV + Ibrutinib. The therapeutic response will be evaluated after the 2nd and the 4th cycle. Patients in good therapeutic response will proceed to the consolidation phase with Autologous Stem Cell Transplantation (ASCT).


title: Catastrophism in Chronic Inflammatory Rheumatism

acronym: CRIC

summary:
Catastrophic is defined as a negative cognitive and emotional response based on inadequate pain expression. It has three components: rumination, amplification and vulnerability. The assessment of catastrophism is carried out using a validated questionnaire called the "Pain Catatrophizing Scale" (PCS).

Recent studies highlight the significant impact of catastrophism in neuromuscular and mechanical rheumatic diseases such as gonarthrosis gonalgia and low back pain. In these diseases, it has been shown that catastrophism has a negative impact both on the experience of pain and on the response to different types of treatments (medical and surgical). Several studies have implemented multidisciplinary management and in particular cognitive-behavioural therapy with an improvement in the pain experience in patients who are catastrophic.

In chronic inflammatory rheumatic diseases such as rheumatoid arthritis, spondyloarthritis and psoriatic arthritis, the prevalence and impact of catastrophism is still poorly understood.

status: Active, not recruiting

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
CHU de Montpellier
CHU de Nîmes


title: From Immune System Damage to Podocyte Cell Damage: Prospective Database and Biological Collection of Patients (Children and Adults) With Minimal Glomerular Injury Nephrotic Syndrome (MGLS) and Primary Segmental and Focal Hyalinosis (HSFP)

acronym: BiobankSNI

summary:
Idiopathic Nephrotic Syndrome (INS) is a kidney disease characterized by massive proteinuria and hypoalbuminemia. It includes two anatomopathological entities: nephrotic syndrome with minimal glomerular lesions (SNLGM) and primary segmental and focal hyalinosis (PHF). Renal biopsy reveals a fusion of the feet of the podocytes without inflammatory lesions or deposits of immune complexes. Clinical and experimental observations strongly suggest that the immune system and podocyte dysfunction are the two facets of the disease. There are currently no clinical or biological markers to predict the diagnosis of corticosteroid sensitivity, corticosteroid dependence, or risk of recurrence of kidney disease after kidney transplantation. To our knowledge, no prospective studies have been designed to study both immune system alterations and podocyte damage as well as genetic predisposition variants in NIS. Therefore, the use of steroids/immunosuppressive agents is purely empirical with a multitude of side effects.

The objective is to identify and test new therapeutic targets rather than conducting new trials with existing treatments, using either drug candidates or molecules selected by high throughput screening of libraries of repositioning molecules using an appropriate read-out. The biobank may also be used to analyze the effects of conventional treatments on identified new biomarkers. We expect the project to produce original and patentable results with subsequent valuation. Patentability will be anticipated before any publication on the subject. The patent and valorization cells of hospitals, INSERM and Universities will be involved in the results as soon as they are obtained.

time_perspective: Prospective

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
APHP
Nice Hospital


title: PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer

acronym: NIRVANA-LUNG

summary:
Overall survival (OS) of patients with advanced (stage IIIB/IV) non-small-cell lung cancer (NSCLC) remains short after the first line of treatment with a median OS of 12.2 months in non squamous NSCLC and 9.2 months in squamous NSCLC . In this setting the programmed death 1/ligand 1 (PD-1/-L1) were targeted with nivolumab (IgG4) in advanced squamous and nonsquamous NSCLC leading to an increase of the 1-year OS rate of approximately 10-15% in both histologies. Nivolumab, pembrolizumab and atezolizumab are now considered a standard of care in 2nd line advanced NSCLC and in 1st line for pembrolizumab but but prognosis still remains poor in advanced NSCLC. Overall survival (OS) of patients with advanced (stage III/IV) NSCLC remains limited with a median OS of 12.2 months in non-squamous NSCLC and 9.2 months in squamous NSCLC if anti-PD1 alone. It is of around 16 months if pembrolizumab is combined with chemotherapy.

Preclinical data indicates that anti-tumor efficacy is increased when anti-PD-1/-L1 are combined with irradiation (IR). Radiotherapy alone can elicit tumor cell death which can increase tumor antigen in the blood stream, favoring recognition by the immune system and its activation against tumor cells outside of the radiation field (="abscopal effect").

IR may also reverse acquired resistance to PD-1 blockade immunotherapy by limiting T-cell exhaustion.

Because of these preclinical and clinical data several studies analysing the combination of IR and anti-PD1 in NSCLC are ongoing. Among them, two studies are testing the administration of IR and nivolumab in stage III NSCLC: the NCT02768558 phase III trial (RTOG), and the NCT02434081 phase II trial (ETOP). Antonia et al [2017] tested the use of anti-PD-L1 after chemoradiotherapy in unresectable stage III NSCLC. Median time to distant metastasis was increased (23.2 months vs. 14.6 months, p<0.001). An increase of OS is consequently expected.

However, no study involving concurrent RT and pembrolizumab combined with chemotherapy in advanced NSCLC is ongoing, which is the purpose of the present study, NIRVANA-Lung.

ReferenceCitation: Doyen J, Besse B, Texier M, Bonnet N, Levy A. PD-1 iNhibitor and chemotherapy with concurrent IRradiation at VAried tumor sites in advanced Non-small cell lung cAncer: the Prospective Randomized Phase 3 NIRVANA-Lung Trial. Clin Lung Cancer. 2022 May;23(3):e252-e256. doi: 10.1016/j.cllc.2021.10.008. Epub 2021 Oct 24.

lead_sponsor: UNICANCER

location_facility: Pôle départemental de Cancérologie Libérale 37

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

location_facility: Centre hospitalier de Cannes Simone Veil

location_facility: Centre Hospitalier Universitaire De Caen - Hôpital Cote De Nacre

location_facility: Centre de cancérologie du grand Montpellier-Clinique Clementville

location_facility: Centre Hospitalier Intercommunal De Creteil


ipd_sharing: Yes

acronym: AMBRE

title: Open-label, Randomized, Multicenter, Phase III Study, Comparing Standard Chemotherapy to Standard Combination of Endocrine Therapy With Abemaciclib as Initial Metastatic Treatment Among Patients With Visceral Metastasis of ER+ HER2-breast Cancer, High Burden Disease

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:
Centre Hospitalier Lyon Sud
Centre Eugène Marquis

summary: AMBRE is a phase III study comparing two standard treatments as initial metastatic treatment in ER+/HER2- breast cancer (BC) patients with visceral metastasis and high burden disease: Chemotherapy and combination of endocrine therapy with abemaciclib.


title: Consumption of New Psychoactive Substances in Intoxicated Patients During the Winter Activities

acronym: SkiTox

summary: The purpose of this research is to identify the New Psychoactive Substances (NPS) that are responsible for intoxicating patients in ski resort during winter activities.

ReferenceType: background

ReferenceCitation: Rivera JV, Vance EG, Rushton WF, Arnold JK. Novel Psychoactive Substances and Trends of Abuse. Crit Care Nurs Q. 2017 Oct/Dec;40(4):374-382. doi: 10.1097/CNQ.0000000000000174. Review.

ReferenceCitation: Yang F-S, Chen C-J, Lin Y-C. "Zombie" Outbreak Caused by Synthetic Cannabinoid. N Engl J Med. 2017 Apr 20;376(16):1596-7. doi: 10.1056/NEJMc1701936.

ReferenceCitation: Frank RG, Pollack HA. Addressing the Fentanyl Threat to Public Health. N Engl J Med. 2017 Feb 16;376(7):605-607. doi: 10.1056/NEJMp1615145.

ReferenceCitation: Khaled SM, Hughes E, Bressington D, Zolezzi M, Radwan A, Badnapurkar A, Gray R. The prevalence of novel psychoactive substances (NPS) use in non-clinical populations: a systematic review protocol. Syst Rev. 2016 Nov 21;5(1):195.

ReferenceCitation: Kunst LE, Gebhardt WA. Prevalence and Psychosocial Correlates of Party-Drug Use and Associated Problems among University Students in the Netherlands. Subst Use Misuse. 2018 Oct 15;53(12):2077-2088. doi: 10.1080/10826084.2018.1455700. Epub 2018 Apr 18.

ReferenceCitation: Palamar JJ, Barratt MJ, Ferris JA, Winstock AR. Correlates of new psychoactive substance use among a self-selected sample of nightclub attendees in the United States. Am J Addict. 2016 Aug;25(5):400-7. doi: 10.1111/ajad.12403. Epub 2016 Jul 15.

ReferenceCitation: Ridpath A, Driver CR, Nolan ML, Karpati A, Kass D, Paone D, Jakubowski A, Hoffman RS, Nelson LS, Kunins HV; Centers for Disease Control and Prevention (CDC). Illnesses and deaths among persons attending an electronic dance-music festival - New York City, 2013. MMWR Morb Mortal Wkly Rep. 2014 Dec 19;63(50):1195-8.

ReferenceCitation: Fox J, Smith A, Yale A, Chow C, Alaswad E, Cushing T, Monte AA. Drugs of Abuse and Novel Psychoactive Substances at Outdoor Music Festivals in Colorado. Subst Use Misuse. 2018 Jun 7;53(7):1203-1211. doi: 10.1080/10826084.2017.1400067. Epub 2017 Nov 17.

ReferenceCitation: Liakoni E, Dolder PC, Rentsch KM, Liechti ME. Presentations due to acute toxicity of psychoactive substances in an urban emergency department in Switzerland: a case series. BMC Pharmacol Toxicol. 2016 May 26;17(1):25. doi: 10.1186/s40360-016-0068-7.

ReferenceCitation: Palamar JJ, Salomone A, Gerace E, Di Corcia D, Vincenti M, Cleland CM. Hair testing to assess both known and unknown use of drugs amongst ecstasy users in the electronic dance music scene. Int J Drug Policy. 2017 Oct;48:91-98. doi: 10.1016/j.drugpo.2017.07.010. Epub 2017 Aug 12.

ReferenceCitation: Miliano C, Margiani G, Fattore L, De Luca MA. Sales and Advertising Channels of New Psychoactive Substances (NPS): Internet, Social Networks, and Smartphone Apps. Brain Sci. 2018 Jun 29;8(7). pii: E123. doi: 10.3390/brainsci8070123. Review.

ReferenceCitation: Robach P, Trebes G, Lasne F, Buisson C, Méchin N, Mazzarino M, de la Torre X, Roustit M, Kérivel P, Botré F, Bouzat P. Drug Use on Mont Blanc: A Study Using Automated Urine Collection. PLoS One. 2016 Jun 2;11(6):e0156786. doi: 10.1371/journal.pone.0156786. eCollection 2016.

ReferenceCitation: Orsini J, Din N, Elahi E, Gomez A, Rajayer S, Malik R, Jean E. Clinical and epidemiological characteristics of patients with acute drug intoxication admitted to ICU. J Community Hosp Intern Med Perspect. 2017 Sep 19;7(4):202-207. doi: 10.1080/20009666.2017.1356189. eCollection 2017 Oct.

ReferenceCitation: Helander A, Bäckberg M, Hultén P, Al-Saffar Y, Beck O. Detection of new psychoactive substance use among emergency room patients: results from the Swedish STRIDA project. Forensic Sci Int. 2014 Oct;243:23-9. doi: 10.1016/j.forsciint.2014.02.022. Epub 2014 Mar 6.

ReferenceCitation: Spiller HA, Ryan ML, Weston RG, Jansen J. Clinical experience with and analytical confirmation of "bath salts" and "legal highs" (synthetic cathinones) in the United States. Clin Toxicol (Phila). 2011 Jul;49(6):499-505. doi: 10.3109/15563650.2011.590812.

ReferenceCitation: Beck O, Franzén L, Bäckberg M, Signell P, Helander A. Toxicity evaluation of α-pyrrolidinovalerophenone (α-PVP): results from intoxication cases within the STRIDA project. Clin Toxicol (Phila). 2016 Aug;54(7):568-75. doi: 10.1080/15563650.2016.1190979.

ReferenceCitation: Bäckberg M, Beck O, Hultén P, Rosengren-Holmberg J, Helander A. Intoxications of the new psychoactive substance 5-(2-aminopropyl)indole (5-IT): a case series from the Swedish STRIDA project. Clin Toxicol (Phila). 2014 Jul;52(6):618-24. doi: 10.3109/15563650.2014.920088. Epub 2014 Jun 4.

lead_sponsor: University Hospital, Grenoble

location_facility:
University Hospital Grenoble
CH Albertville Moutiers


title: Best PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.

acronym: PREDICTOR

summary:
No prospective study was conducted in elderly patients with cancer to assess the relative value of disease-related and patient-related prognosis factors. Patient-related prognostic factors have been highlighted in elderly patients with cancer resulting in the necessity of a geriatric assessment. The impact on overall survival of all of these factors was recognized in elderly people with cancer but remains unknown in High Risk Myelodysplastic Syndromes (HR-MDS). Therefore this information could be crucial to better select geriatric assessment domains relevant for the prediction and to recommend simplified tool after stratification of geriatric assessment domains thanks to their predictive value.

The main hypothesis is that patient-related factors will have a better capacity to predict survival and treatment tolerance than disease-related factors in HR-MDS aged 75 and over and that the predictive value will be different among assessment tools which allows a selection of reduced number of tools for clinical use.

To best knowledge estimation of predictive value of geriatric assessment tools remains unknown and explains why no standardization of practice exists. In testing all tools at the same cohort of patients allows to compare different tools and to define minimal and optimal geriatric assessment for HR-MDS. To determine the best strategy of geriatric assessment will allow in a second time to measure the impact of the use of this geriatric standardized evaluation by comparing patients'care and prognosis according to the use or not by the doctors of the new scores.

Research outcomes are various medical, economic and ethic. Medical because decision-making will be improved with simplified geriatric assessment; economic because a better knowledge of geriatric assessment will improve treatment toxicity prevention and decrease treatment costs. Ethic will be associated with this project because a better knowledge of geriatric assessment tools to predict survival and tolerance treatment could improve the choice of best supportive care if prognosis markers are not favorable to active therapy. This project could induce important modification of practice in this area to an improved personalized treatment and simplification of geriatric assessment allowing a large diffusion in hospitals and clinics.

lead_sponsor: University Hospital, Toulouse

location_country: France Monaco

location_facility: Hôpital saint vincent de paul - Institut Catholique


title: A Randomized Cross-over Trial Evaluating the Efficacy of Diuretics for Symptomatic Malignant Ascites Episodes in Advanced Palliative Stage of Cancer

summary:
While some authors recommend diuretics as the first treatment to initiate for symptoms caused by malignant ascites (MA), their prescription is variable. No randomized, controlled study has assessed their benefit in this context. According to literature, diuretics may bring relief in about 40% of cases, regardless of primary tumor.

The purpose of our study is to assess the effectiveness of diuretic treatment according to Serum Ascites Albumin Gradient (SAAG) measured before treatment. Judgment criteria is the time elapsed between recurrent MA that requires paracentesis. The investigators will also examine whether SAAG and serum levels of renin and aldosterone can predict symptom response to diuretics.

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Intercommunal Compiègne-Noyon


title: Prevalence of Primary Aldosteronism Among Hypertensive Patients Younger Than 65 Years Old With Atrial Arythmia

acronym: HAPAA

summary:
Atrial arrhythmia is the most frequent cardiac arrhythmia. It is a source of significant morbidity.

Hypertension is a major risk factor for atrial arrhythmias. Primary hyperaldosteronism (PA) is a common cause of secondary hypertension, associated with a high prevalence of arrhythmias with a specific, sometimes curative, treatment. The purpose of the study is to show that the prevalence of PA among hypertensive patients under 65 years old with atrial arrhythmia is high, justifying systematic screening.

lead_sponsor: Centre Hospitalier de PAU

location_facility:
CHU de Bordeaux
CH de Pau

intervention_type: Diagnostic Test


title: A Phase III Trial of Acetylsalicylic Acid and Atorvastatin in Patients With Castrate-resistant Prostate Cancer

summary:
This is a 2x2 factorial randomized, multicenter, international, open phase III trial.

The primary objective is to evaluate the benefit of acetylsalicylic acid and atorvastatin on overall survival (OS) (main endpoint) for patients with castrate-resistant prostate cancer starting first line treatment for CRPC

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: France Switzerland

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: Tracking Triple-negative Breast Cancer Evolution Through Therapy

acronym: TRACERX-TNBC

summary: A prospective multicentre study which aims to examine the relationship between intratumour heterogeneity (ITH) and pathological response to neoadjuvant chemotherapy in patients with histological confirmation of triple-negative breast cancer (TNBC) who are eligible for neoadjuvant chemotherapy.

location_facility: Hopitaux universitaire de strasbourg - Hopital civil

intervention_type: Procedure


title: PReoperative Chemoradiation With Paclitaxel-carboplatin or With Fluorouracil-oxaliplatine-acide Folinique (FOLFOX) for Resectable Esophageal and Junctional Cancer - A Randomized Phase II Trial

acronym: PROTECT

summary:
Resectable esophageal or junctional cancer requires medical treatment by radiotherapy and chemotherapy followed by surgery. Currently, one of the most commonly used chemotherapy treatment is the FOLFOX. It is a combination of three drugs administered intravenously: fluorouracil, oxaliplatin and folinic acid. This is the standard treatment.

Another protocol of chemotherapy is widely used by certain European and American teams, due to promising results : a combination of two drugs administered intravenously: Paclitaxel and Carboplatin (CarboP-pacliT). At present, no clinical study has shown the superiority of one treatment over the other.

The objective of this Phase II study is to clarify clinical practice by comparing these two chemotherapy treatments.

ReferenceCitation: Messager M, Mirabel X, Tresch E, Paumier A, Vendrely V, Dahan L, Glehen O, Vasseur F, Lacornerie T, Piessen G, El Hajbi F, Robb WB, Clisant S, Kramar A, Mariette C, Adenis A. Preoperative chemoradiation with paclitaxel-carboplatin or with fluorouracil-oxaliplatin-folinic acid (FOLFOX) for resectable esophageal and junctional cancer: the PROTECT-1402, randomized phase 2 trial. BMC Cancer. 2016 May 18;16:318. doi: 10.1186/s12885-016-2335-9.

location_facility:
ICM - Val d'Aurelle
ICO Paul Papin
University Hospital of Lille
Hôpital La Timone
CH Lyon sud
CHU Bordeaux
Hôpital Nord
Centre Oscar Lambret
ICO René Gauducheau
Centre Eugène Marquis


title: A National, Multicenter, Phase III Randomized Controlled Trial to Assess the Impact of a One-year Supervised Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients

acronym: STARTER

summary: Testicular germ cell tumor (TGCT) is the most common malignancy in men between 15 and 40 years. Although TCGT survivors have a good survival prognosis, they suffer from short- and long-term sequelae such as chronic fatigue, psychological disorders, cardiovascular toxicities and second malignancies. The benefits of physical activity (PA) during treatments have been demonstrated in cancer patients to improve quality of life (QoL) and physical fitness and to reduce fatigue. However, few PA programs have been proposed to TGCT patients and their effects on sequelae have not been assessed yet. A growing body of evidence links treatment-related alteration in the gut microbiota to sequelae of cancer survivors, including fatigue and cardiovascular toxicities. Also, PA has been known as a possible modulator of the gut microbiota composition. To date, no study has been conducted to examine how the gut microbiota and its metabolites moderate the effect of PA on fatigue and other late effects in TGCT survivors. The objectives will be to assess the impact of a PA program on fatigue and other sequelae and to investigate how the gut microbiota and its metabolites moderate the associations between PA and sequelae. We will conduct a prospective, multicenter, phase III, randomized controlled trial of a one-year supervised PA program. 236 men with metastatic TGCT and eligible for a first line of chemotherapy will be randomly assigned to either PA intervention or control arm. All patients will benefit from a connected activity tracker and PA recommendations. In the intervention arm, PA will be based on supervised sessions and motivational interviews. The primary endpoint (fatigue) will be assessed at 3 years. The trial will provide novel insights into the impact of PA on fatigue and other sequelae in TGCT survivors with understanding a potential underlying mechanism of gut microbiota. This evidence will support the development of targeted PA guidelines to improve QoL and reduce sequelae in TGCT survivors.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Supportive Care

lead_sponsor: Centre Leon Berard

location_facility:
Institut Bergonié
CHU Jean Minjoz
Centre Antoine Lacassagne
Institut de Cancérologie de Lorraine
Centre Oscar Lambret
Centre Leon Berard
Centre Eugène Marquis
Centre François Baclesse

intervention_type: Behavioral


title: UNDER the Nose vs. Over the Nose Face Mask to Prevent Facial PRESSURE Ulcers During Face Mask-noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

acronym: UNDER PRESSURE

summary:
Noninvasive ventilation (NIV) is essential to treat acute hypercapnic respiratory failure. However, facial pressure ulcers appearing during facemask-delivered noninvasive ventilation are a source of NIV failure by interface intolerance.

A Philips facemask (model : AF541 SE Oro-Nasal mask) has the particularity to display two options for its positioning : a usually used "over-the-nose" positioning or an "under-the-nose" positioning that is supposed to reduce the incidence of facial pressure ulcers while keeping in the same time the qualities of a standard facemask.

The goal of this controlled randomized trial is to test the hypothesis that the "under-the-nose" positioning actually reduces the incidence of facial pressure ulcers, compared to the usually used "over-the-nose" positioning.

Results of this trial should lead to the proposition of a new interface strategy to prevent facial pressure ulcers and therefore to improve the tolerance of NIV via the use of facemasks displaying an "under-the-nose" positioning.

ReferenceCitation: Edsberg LE, Black JM, Goldberg M, McNichol L, Moore L, Sieggreen M. Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs. 2016 Nov/Dec;43(6):585-597.

ReferenceCitation: Lemyze M, Mallat J, Nigeon O, Barrailler S, Pepy F, Gasan G, Vangrunderbeeck N, Grosset P, Tronchon L, Thevenin D. Rescue therapy by switching to total face mask after failure of face mask-delivered noninvasive ventilation in do-not-intubate patients in acute respiratory failure. Crit Care Med. 2013 Feb;41(2):481-8. doi: 10.1097/CCM.0b013e31826ab4af.

ReferenceCitation: Gregoretti C, Confalonieri M, Navalesi P, Squadrone V, Frigerio P, Beltrame F, Carbone G, Conti G, Gamna F, Nava S, Calderini E, Skrobik Y, Antonelli M. Evaluation of patient skin breakdown and comfort with a new face mask for non-invasive ventilation: a multi-center study. Intensive Care Med. 2002 Mar;28(3):278-84. Epub 2002 Feb 6.

lead_sponsor: Centre Hospitalier Arras

location_facility:
Centre Hospitalier Arras
Centre Hospitalier Lens


title: A Phase II Study Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Oligo Brain Metastases.

acronym: NANOSTEREO

summary: This study evaluates the clinical impact of AGuIX® nanoparticles in combination with Fractionated Stereotactic Radiation in oligo brain metastases.

location_facility:
Centre Léon Bérard
Centre Antoine Lacassagne


title: Randomized Prospective Study Evaluating the Benefit of the Treatment of the Distal Amputation Sequelae of the Fingers by Lipofilling - LIPOFILLING Study

acronym: LIPOFILLING

summary: The purpose of this study is to evaluate the contribution of autologous graft reinjection (lipofilling) in the treatment of dysaesthesic pulp.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
CH de Cornouaille - Quimper
CHRU de Brest


title: Treatment of Severe and Resistant Obsessive-compulsive Disorder by High-frequency Stimulation of the Ventral Striatum and the Subthalamic Nucleus

summary: Obsessive-compulsive disorder (OCD) is a relatively common psychiatric condition, which is classically treated by antidepressant medications in combination with psychotherapies. However, both these conventional therapeutic approaches fail to sufficiently improve obsessive-compulsive symptoms in 20-30% of cases. From these considerations, deep brain stimulation (DBS), as a reversible and adjustable surgical procedure, has recently been introduced in the field of resistant OCD. DBS currently uses electrodes with four contacts on each lead, which are bilaterally implanted into the chosen brain structure. DBS consists of the delivery of a high-frequency current through the quadripolar electrodes connected to a battery powered pulse-generating device. Several clinical investigations have shown that DBS, primarily targeting either the ventral striatum (VS) or the subthalamic nucleus (STN), as brain sites of interest because of their particular involvement in the production of OCD symptoms, is able to produce an approximately 40% or greater reduction in clinical symptom intensity in severely chronic and incapacitating forms of OCD. These promising findings lead to propose a comparison of the efficacy, safety and tolerability of DBS choosing either the VS or STN as brain target by conducting a large controlled trial and including a medico-economic analysis for assessing the classical cost/efficacy ratio. In this way, the present study is expected to promote and highlight the importance of DBS, as an effective, safe, well-tolerated and cost-relevant surgical approach for the management of resistant OCD.

ReferenceCitation: Aouizerate B, Cuny E, Bardinet E, Yelnik J, Martin-Guehl C, Rotge JY, Rougier A, Bioulac B, Tignol J, Mallet L, Burbaud P, Guehl D. Distinct striatal targets in treating obsessive-compulsive disorder and major depression. J Neurosurg. 2009 Oct;111(4):775-9. doi: 10.3171/2009.2.JNS0881.

ReferenceCitation: Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chéreau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardès S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Vérin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. Erratum in: N Engl J Med. 2009 Sep 3;361(10):1027.

lead_sponsor: University Hospital, Bordeaux

location_facility:
Lille University Hospital
Poitiers University Hospital
Sainte-Anne Hospital
Strasbourg University Hospital
Henri Mondor Hospital
Toulouse University Hospital
Marseille University Hospital
Pitié-Salpêtrière Hospital
Rennes University Hospital
Nice University Hospital
Bordeaux University Hospital
Lyon University Hospital
Clermont-Ferrand University Hospital
Grenoble University Hospital


title: OCT-angiography as a Pronostic Marker for Visual Impairment in Patients Undergoing Neurosurgery for Compressive Macroadenoma : a Prospective Study.

acronym: FIRST

summary: The aim of the study is to assess accurancy of OCT angiography as a pronostic marker for patients undergoing neurosurgery for compressiver macroadenoma as compared with visual acuity, visual field and OCT.

status: Unknown status

primary_purpose: Prevention

location_facility: Hôpital Pasteur 2 - Service d'Ophtalmologie


title: Prediction of the Risk of Biochemical Relapse After Radical Prostatectomy for Prostate Cancer Using Radomics on Pre-therapeutic MRI

acronym: PREBOP

summary:
With 50% of post-operative biochemical failure, efficient predictive models are needed to guide post-operative management.

Radiomic features are quantitative features extracted from medical imaging, supposed to be correlated with tumor heterogeneity.

We aim to build and test three predictive models (clinical, radiomic and combined models).

time_perspective: Retrospective

location_facility:
Centre Hospitalier de Cornouaille
CHRU de Brest


title: Evaluation of the Characteristics, Prevalence and Prognosis of Pulmonary Hypertension in Adult Patients With Sickle Cell Disease: Study ETENDARD.

acronym: ETENDARD

summary: Recent data show that pulmonary hypertension (PH), defined by a tricuspid regurgitation jet (TRJ) velocity > or equal at 2.5m/s on Doppler echocardiography, is present in about 30% of adults with sickle cell disease (SCD) and is associated with poor prognosis. However in SCD the occurrence of PH (defined by mean pulmonary arterial pressure (mPAP)> or equal at 25 mmHg) is related to at least 3 mechanisms: PH due to hyperkinetic state with high cardiac output (CO) but normal pulmonary vascular resistance (PVR <160 dynes), or postcapillary PH (pulmonary capillary wedge pressure PCWP >15 mmHg), or precapillary pulmonary arterial hypertension (PAH) defined by mPAP > or equal at 25 mmHg, PCWP< or equal at 15 mmHg and PVR > or equal at 160 dynes.The aim of this study is to evaluate in a French population of adults with sickle cell disease the characteristics, prevalence and prognosis of pulmonary hypertension.

ReferenceCitation: Simonneau G, Galiè N, Rubin LJ, Langleben D, Seeger W, Domenighetti G, Gibbs S, Lebrec D, Speich R, Beghetti M, Rich S, Fishman A. Clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2004 Jun 16;43(12 Suppl S):5S-12S. Review.

ReferenceCitation: Rubin LJ, Badesch DB, Barst RJ, Galie N, Black CM, Keogh A, Pulido T, Frost A, Roux S, Leconte I, Landzberg M, Simonneau G. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med. 2002 Mar 21;346(12):896-903. Erratum in: N Engl J Med 2002 Apr 18;346(16):1258.

ReferenceCitation: Humbert M, Sitbon O, Simonneau G. Treatment of pulmonary arterial hypertension. N Engl J Med. 2004 Sep 30;351(14):1425-36. Review.

ReferenceCitation: Lechapt E, Habibi A, Bachir D, Galacteros F, Schaeffer A, Desvaux D, Brochard L, Housset B, Godeau B, Maitre B. Induced sputum versus bronchoalveolar lavage during acute chest syndrome in sickle cell disease. Am J Respir Crit Care Med. 2003 Dec 1;168(11):1373-7. Epub 2003 Sep 11.

ReferenceCitation: Maitre B, Habibi A, Roudot-Thoraval F, Bachir D, Belghiti DD, Galacteros F, Godeau B. Acute chest syndrome in adults with sickle cell disease. Chest. 2000 May;117(5):1386-92.

ReferenceCitation: Parent F, Bachir D, Inamo J, Lionnet F, Driss F, Loko G, Habibi A, Bennani S, Savale L, Adnot S, Maitre B, Yaïci A, Hajji L, O'Callaghan DS, Clerson P, Girot R, Galacteros F, Simonneau G. A hemodynamic study of pulmonary hypertension in sickle cell disease. N Engl J Med. 2011 Jul 7;365(1):44-53. doi: 10.1056/NEJMoa1005565.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: An International Multicenter Phase II Trial of Durvalumab (MEDI4736) Plus OLAparib Plus Fulvestrant in Metastatic or Locally Advanced ER-positive, HER2-negative Breast Cancer Patients Selected Using Criteria That Predict Sensitivity to Olaparib

acronym: DOLAF

summary: This study evaluates the efficacy of the combination of olaparib, durvalumab, and fulvestrant for the treatment of patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer with BRCA gene alterations or alterations of genes involved in homologous recombination repair (HRR) or microsatellite instability (MSI) status.

location_facility:
Centre Henri-Becquerel
Institut de Cancerologie de Montpellier


title: Effect of Transorbital Electrical STIMulation of Optic Nerve on Remyelination After an Acute Optic Neuritis

acronym: ONSTIM

summary:
In light of experimental models showing that neuronal electrical activity is crucial for the remyelination process, we hypothesize that maintenance of electrical axonal activity in the early stages of optic neuritis may promote myelin repair, limiting thereby axonal degeneration.

In humans, electrical stimulation of the optic nerve has been tested mainly in ischemic neuropathy and retinitis pigmentosa, which are both associated with severe axonal/retinal pathology and poor visual prognosis. In contrast, the inflammation of the optic nerve in optic neuritis is generally transient, with less severe axonal damage at the acute phase, which would allow for better efficacy of electrical stimulation as a strategy to promote remyelination and neuroprotection.In light of experimental models showing that neuronal electrical activity is crucial for the remyelination process, we hypothesize that maintenance of electrical axonal activity in the early stages of optic neuritis may promote myelin repair, limiting thereby axonal degeneration.

In humans, electrical stimulation of the optic nerve has been tested mainly in ischemic neuropathy and retinitis pigmentosa, which are both associated with severe axonal/retinal pathology and poor visual prognosis. In contrast, the inflammation of the optic nerve in optic neuritis is generally transient, with less severe axonal damage at the acute phase, which would allow for better efficacy of electrical stimulation as a strategy to promote remyelination and neuroprotection.

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

location_facility: Institut du Cerveau et de la Moelle epiniere - Hopital Pitie Salpetriere


title: iDEFCO: Implementation of a Tool to Identify Social Weaknesses in the Cancer Care Pathway

acronym: iDEFCO

summary: Social inequalities in the face of cancer are significant in all countries. They are characterized by higher mortality among people may be in the lower socioeconomic category. The care pathway may also be a source of inequality or accentuate inequalities. Socially vulnerable patients must be provided with appropriate care. It is therefore necessary to identify patients with such social vulnerabilities as early as possible and to take them into account throughout the care process. To meet this need, the DEFCO project ("Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system") was designed and conducted by the Centre Hygée at the Lucien Neuwirth Cancer Institute (ICLN) in 2014 and 2015, in partnership with an industrial engineering research laboratory, the DISP ("Décision & Information pour les Systèmes de Production"). Its objective was to develop a tool for systematic screening of social fragility, involving few caregivers and making it possible to identify patients most at risk of social maladjustment. The choice was made to develop a self-administered questionnaire using tablets connected to a neural network. Since its implementation, the deployment of the DEFCO project ("Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system") tool at the Lucien Neuwirth Cancer Institute (ICLN) has required several training and awareness-raising activities to strengthen the motivation of the various stakeholders. These same actors have also implemented different strategies to optimize the functioning of the tool. Developed in a specialized institution, this tool must demonstrate, in this second stage of the project, it transferability and it possibilities of implementation in other structures. It is also necessary to evaluate it in terms of it is impact, particularly on the fluidity of care pathways and on the social consequences of the disease.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Hospices Civils de Lyon, Groupement Hospitalier Est - Gynécologie

location_facility: Hospices Civils de Lyon, Groupement Hospitalier Nord - Gynécologie

location_facility: Hospices Civils de Lyon, Centre Hospitalier Lyon Sud - Oncologie digestive


title: Comparison of Patient Work of Breathing and Tidal Volumes With High-flow Nasal Cannula Oxygen Therapy and Non-invasive Ventilation After Extubation in the ICU: a Prospective, Randomized, Controlled Study

acronym: OVNI

summary: This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.

ReferenceCitation: Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3:CD010172. doi: 10.1002/14651858.CD010172.pub3.

lead_sponsor: Poitiers University Hospital

location_facility:
CHU Poitiers
Intensive reanimation


title: Place of the QuantiFERON-CMV (QF-CMV) Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis (UC)

acronym: RECOHFERRON

summary: CytoMegaloVirus (CMV) infection impairs evolution of Ulcerative Colitis (UC) leading to more severe and resistant to immunosuppressive therapies flare-up. CytoMegaloVirus (CMV) reactivation is assessed by the quantification of the CytoMegaloVirus (CMV) DeoxyriboNucleic Acid (DNA) load by real-time PCR (qPCR) in colonic biopsies; this assay is invasive and costly. The QuantiFERON-CytoMegaloVirus (QF-CMV) assay measures the immune response against CytoMegaloVirus (CMV) in a blood specimen.

location_facility:
HCL-Hôpital Lyon Sud
Chu Saint-Etienne


title: Towards a Better Understanding of Neuromuscular Alterations and Fatigue in Chronic Obstructive Pulmonary Disease (COPD)

acronym: NEUROTIGUE

summary:
Fatigue is a prevalent symptom in Chronic Obstructive Pulmonary Disease (COPD) that limits patients in their daily living activities. It is now well established that COPD patients may have altered neuromuscular functions compared to healthy individuals. However, the different studies conducted on muscle fatigue in COPD have been done independently of any cognitive solicitation, yet present in most of daily living activities. Therefore, the aim of this research is to evaluate the impact of the disease on neuromuscular fatigue during dual-task situation (simultaneous accomplishment of a muscle contraction and a cognitive task). A better understanding of fatigue in COPD will promote the development of new perspectives in patient management.

The hypothesis is that COPD patients will exhibit increased fatigue level (compared to healthy subjects), particularly during dual-task situation. It is assumed that the higher negative effect associated with the dual-task will be related to different neurophysiological mechanisms (i.e., neuromuscular fatigue, autonomic nervous system activity, mental fatigue).

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Université de Toulon, laboratoires LAMHESS et IAPS

location_facility: Hôpital d'Instruction des Armées Sainte-Anne


title: Multicenter Prospective Cohort of Informal Caregivers in Burgundy-Franche-Comté. ICE Cohort (Informal Caregivers of Elderly)

acronym: ICE

summary:
Medical progress and modification of lifestyles have prolonged life expectancy, despite the development of chronic diseases. The support and care are often provided by a network of informal caregivers composed of family, friends, and neighbors. They became essential to help maintening the elderly persons to live at home. It has been demonstrated that the importance and the diversity of informal tasks may jeopardize their own physical, mental and social well-being.

The aim of the Informal Carers of Elderly Cohort is to define, through a longitudinal study of their life course, the profiles of caregivers of patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colon-rectum), neuro-degenerative diseases (Parkinson's disease, Alzheimer's and similar diseases), neuro-vascular diseases (Cerebrovascular Accident (CVA)), Age-related Macular Degeneration(AMD) and heart disease (heart failure), aged ≥ 60 years old and living in Burgundy or Franche-Comte. By following the different phases of the caregiving relationship from the announcement of the diagnosis, it will be possible to assess the quality of life of caregivers and evaluate the implementation of a pragmatic social action to help informal caregivers through a randomized intervention trial nested in the cohort.

Thanks to an analytical and longitudinal definition of the profiles of informal caregivers, this study could gather precise information on their life courses and their health trajectory by identifying the consequences associated with the concept of their role of aid in care. In addition, the randomized intervention trial will explore the efficacy, in terms of quality of life, and efficiency of a social action to support the caregivers. These data will allow to identify strategies that could be used to improve the existing sources of aid and to propose new approaches to help caregivers. This study will provide the opportunity to identify the most relevant means of support and to give an impulse for new healthcare policies.

ReferenceCitation: Pozet A, Lejeune C, Bonnet M, Dabakuyo S, Dion M, Fagnoni P, Gaimard M, Imbert G, Nerich V, Foubert A, Chotard M, Bonin M, Anota A, Bonnetain F. Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial. Trials. 2016 Nov 3;17(1):531.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery

acronym: E-CTC

summary: The purpose of this study is to investigate the spread of Circulating Tumor Cells (CTC) during surgery in endometrial cancer. Although this cancer is often discovered at early stage, the risk of recurrence is estimated at 6 to 21%, according to grade. Early stage tumor is accessible for curative surgical treatment by laparoscopy but this kind of surgery may induce CTCs spread, and could be an explanation of this recurrence. Through this study, concordance between two blood punction sites, peripheral vein and ovarian vein, will be evaluated to detect these cells during surgery.

lead_sponsor: University Hospital, Montpellier

location_facility:
Montpellier University Hospital
CHU de Nîmes


title: Individual and Socio-economic Determinants of Patient Delay in Doctor Consultation in Oeso-gastric Cancers

acronym: DELOGAST

summary: This study evaluates the role of socioeconomic and individual factors in the onset of the first symptoms of cancer and the first consultation with a doctor (patient delay) in oeso-gastric cancer.

lead_sponsor: University Hospital, Lille

location_facility:
Centre oscar Lambret
Centre hospitalier de Roubaix
CHRU, Hôpital Claude Huriez
Centre hospitalier de Calais
Centre hospitalier de valenciennes
Centre Hospitalier de Seclin
Centre hospitalier de Béthune
Centre Hospitalier de Boulogne sur mer
Centre d 'oncologie Dunkerquois
centre Léonard de Vinci


title: Four Year Outcome After Severe Traumatic Brain Injury in the Parisian Area

acronym: PariS-TBI

summary:
The primary objective of the protocol is to study the long-term outcome of a large group of traumatic brain injury patients.

This outcome is to be described in terms of activity, participation, quality of life, SOCIO-professional outcome and impact on caregivers, and in relation to health care provision.

The secondary outcome is to measure the impact on functional outcome of several predictive factors, and their relative importance on outcome. Our principal hypothesis is that SOCIO-professional and health provision factors play a major role on long-term outcome, further even than initial severity of brain injury.

ReferenceCitation: Vallée F, Nougue H, Cartailler J, Koundé PR, Mebazaa A, Gayat E, Azouvi P, Mateo J. The ICEBERG: A score and visual representation to track the severity of traumatic brain injury: Design principles and preliminary results. J Trauma Acute Care Surg. 2022 Aug 1;93(2):229-237. doi: 10.1097/TA.0000000000003515. Epub 2022 Jan 6.

location_facility: CRFTC Centre Ressources Francilien du Traumatisme Crânien


title: Sedation in Palliative Care Management Context for Cancer Patients

summary: This study aims to explore deeply the representations and emotional impact of MS on caregivers (doctors and nurses) and relatives of cancer patients. It also aims to describe their collaboration modalities, roles and responsibilities during the decision-making process, implementation and "control" of MS. The project is a multi-center psychosocial study (home, hospitals and palliative care unit) that will take the form of a comprehensive qualitative study, both prospective (participant observation) and retrospective (interview), of patients with and without cancer, for which MS has been administered.

ReferenceCitation: Vieille M, Dany L, Coz PL, Avon S, Keraval C, Salas S, Bernard C. Perception, Beliefs, and Attitudes Regarding Sedation Practices among Palliative Care Nurses and Physicians: A Qualitative Study. Palliat Med Rep. 2021 May 24;2(1):160-167. doi: 10.1089/pmr.2021.0022. eCollection 2021.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Natural History Characterization in Symptomatic and Asymptomatic Progranuline Gene Mutation Carriers

acronym: Predict-PGRN

summary: The purpose of this study is to investigate whether cognitive deficits, structural and functional changes can be detected before symptom onset in presymptomatic progranuline mutation carriers. The main objectives of the project are to identify novel cognitive, brain imaging markers and peripheral biomarkers for early diagnosis of FTLD, and to follow disease progression.

ReferenceCitation: Caroppo P, Habert MO, Durrleman S, Funkiewiez A, Perlbarg V, Hahn V, Bertin H, Gaubert M, Routier A, Hannequin D, Deramecourt V, Pasquier F, Rivaud-Pechoux S, Vercelletto M, Edouart G, Valabregue R, Lejeune P, Didic M, Corvol JC, Benali H, Lehericy S, Dubois B, Colliot O, Brice A, Le Ber I; Predict-PGRN study group. Lateral Temporal Lobe: An Early Imaging Marker of the Presymptomatic GRN Disease? J Alzheimers Dis. 2015;47(3):751-9. doi: 10.3233/JAD-150270.

ReferenceCitation: Saracino D, Dorgham K, Camuzat A, Rinaldi D, Rametti-Lacroux A, Houot M, Clot F, Martin-Hardy P, Jornea L, Azuar C, Migliaccio R, Pasquier F, Couratier P, Auriacombe S, Sauvée M, Boutoleau-Bretonnière C, Pariente J, Didic M, Hannequin D, Wallon D; French Research Network on FTD/FTD-ALS; PREV-DEMALS and Predict-PGRN study groups, Colliot O, Dubois B, Brice A, Levy R, Forlani S, Le Ber I. Plasma NfL levels and longitudinal change rates in C9orf72 and GRN-associated diseases: from tailored references to clinical applications. J Neurol Neurosurg Psychiatry. 2021 Dec;92(12):1278-1288. doi: 10.1136/jnnp-2021-326914. Epub 2021 Aug 4.

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Charles Foix


title: A New Membrane Obturator Prothesis Concept for Soft Palate Defects

acronym: VELOMEMBRANE

summary: When soft palate defects lead to palatal insufficiency, the patient's quality of life is affected by difficulties swallowing, hypernasality, and poor intelligibility of speech. If immediate surgical reconstruction is not an option, the patient may benefit from the placement of a rigid obturator prosthesis. Unfortunately, the residual muscle stumps are often unable to adequately move this stiff and inert obturator to properly restore the velopharyngeal valve function. The objective of this case report was to describe the use of a membrane obturator prosthesis that incorporates a dental dam to compensate for the soft palate defect.

ReferenceCitation: Naveau A, Kret M, Plaire V, Delorme O, Marchi S, de Bataille C, Destruhaut F, Arrive E, Bou C. Efficacy of a new membrane obturator prosthesis in terms of speech, swallowing, and the quality of life of patients with acquired soft palate defects: study protocol of the VELOMEMBRANE randomized crossover trial. Trials. 2022 Mar 18;23(1):221. doi: 10.1186/s13063-022-06163-6.

location_facility:
CHU de Toulouse
CHU de Bordeaux


title: ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial (ALCHEMIST), Phase III b

acronym: ALCHEMIST

summary: This study is designed to etablish the effects of spironolactone in comparison to placebo on the composite endpoint of nonfatal Myocardial Infarction (MI) and acute coronary syndrome, hospitalization for heart failure, nonfatal stroke or cardiovascular-induced death. The primary endpoint will be the time to onset of the first incident.

ReferenceCitation: Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2:CD013109. doi: 10.1002/14651858.CD013109.pub2.

location_country: France Monaco Belgium

location_facility: Hôpitaux Privés de Metz- Hôpital Robert Schuman


type: Registry Identifier

title: Double-blind Multicenter Phase III Trial Evaluating the Efficacy of an Oral Immunomodulatory Nutrient on Survival During Postoperative Concomitant Chemoradiotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC)

summary: The investigators designed a prospective randomized double-blind trial to determine if the oral immunomodulating formula could improve the disease-free survival rate in high-risk locally-advanced head and neck Squamous Cell Carcinoma patients treated with Chemoradiotherapy.

ReferenceCitation: Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, Kish JA, Kim HE, Cmelak AJ, Rotman M, Machtay M, Ensley JF, Chao KS, Schultz CJ, Lee N, Fu KK; Radiation Therapy Oncology Group 9501/Intergroup. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N Engl J Med. 2004 May 6;350(19):1937-44.

ReferenceCitation: Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefèbvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52.

ReferenceCitation: Machon C, Thezenas S, Dupuy AM, Assenat E, Michel F, Mas E, Senesse P, Cristol JP. Immunonutrition before and during radiochemotherapy: improvement of inflammatory parameters in head and neck cancer patients. Support Care Cancer. 2012 Dec;20(12):3129-35. doi: 10.1007/s00520-012-1444-5. Epub 2012 Mar 28.

ReferenceCitation: Vasson MP, Talvas J, Perche O, Dillies AF, Bachmann P, Pezet D, Achim AC, Pommier P, Racadot S, Weber A, Ramdani M, Kwiatkowski F, Bouteloup C. Immunonutrition improves functional capacities in head and neck and esophageal cancer patients undergoing radiochemotherapy: a randomized clinical trial. Clin Nutr. 2014 Apr;33(2):204-10. doi: 10.1016/j.clnu.2013.06.008. Epub 2013 Jun 20.

ReferenceCitation: De Geest S, Sabaté E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323.

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

location_facility:
Centre Léon Bérard
Institut du Cancer de Montpellier

intervention_type: Dietary Supplement


title: Phase III Multicentric Trial Comparing Accelerated Partial Breast Irradiation (APBI) Versus Standard or Hypofractionated Whole Breast Irradiation in Low Risk of Local Recurrence of Breast Cancer

acronym: SHARE

summary:
The standard treatment for localized breast cancer is based on conservative surgery (when possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the difficulty for many patients to reach RT centers to receive standard whole breast irradiation (WBI) after conservative surgery. APBI offers decreased overall treatment time and several theoretical advantages over WBI, including a decrease in dose delivered to uninvolved portions of the breast and adjacent organs. If equivalence between the two treatments can be shown, then APBI will be considered as a historic evolution in breast cancer management.

In this phase III trial, designed in postmenopausal women >50 years of age, the objective is to compare the effectiveness and safety of APBI compared with whole breast irradiation. This study is also designed to ensure high quality criteria for surgery, pathology and RT techniques in the 3 arms and will allow to provide data on economics and costs.

ReferenceCitation: Belkacemi Y, Bourgier C, Kramar A, Auzac G, Dumas I, Lacornerie T, Mége JP, Mijonnet S, Lemonnier J, Lartigau E. SHARE: a French multicenter phase III trial comparing accelerated partial irradiation versus standard or hypofractionated whole breast irradiation in breast cancer patients at low risk of local recurrence. Clin Adv Hematol Oncol. 2013 Feb;11(2):76-83. Review.

lead_sponsor: UNICANCER

location_facility: Centre de traitement des Hautes energie - Clinique de l'Europe


title: Evaluation of the Impact of Diving Training on Recovery in a Cohort of Veterans Suffering of PTSD: an Exploratory Clinical Control Trial

acronym: cognidive

summary:
Patients suffering from Chronic Posttraumatic Stress Disorder (PTSD) have difficulties in executive cognition that hinder their quality of life and make it difficult to recovery and to reintegrate them socially and professionally. These difficulties are particularly important for soldiers suffering from chronic PTSD.

The literature suggests that diving may be a complementary approach to improving cognition, in addition to its benefits on the quality of life of patients with chronic PTSD. It appears to be an intervention of interest to improve the successful recovery for veterans with PTSD compared to a multi-sport practice.

lead_sponsor: Institut de Recherche Biomedicale des Armees

location_facility:
Marion
anne-sophie Pellen


title: A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL).

summary: The primary objective of this study is to evaluate the safety and the efficacy of an adult "acute lymphoblastic leukaemia" type chemotherapy in patients less than 60 years with lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed intensification.

ReferenceCitation: Le Gouill S, Lepretre S, Brière J, Morel P, Bouabdallah R, Raffoux E, Sebban C, Lepage E, Brice P. Adult lymphoblastic lymphoma: a retrospective analysis of 92 patients under 61 years included in the LNH87/93 trials. Leukemia. 2003 Nov;17(11):2220-4.

lead_sponsor: Centre Henri Becquerel

location_country: France Belgium

location_facility: Centre Hospitalier de La Region Annecienne

location_facility: Cliniques Universitaires U C L de Mont Godinne


title: Observatoire Des Patients Atteints de Laminopathies et Emerinopathies (Observatory for PAtients With Laminopathies and Emerinopathies)

acronym: OPALE

summary:
Laminopathies and emerinopathies are complex group of rare disorders due to mutations in A-type lamins (LMNA) and Emerin (EMD) genes. Among them, disorders affecting skeletal and/or cardiac muscles are the most frequent clinical manifestations, with cardiac disease being a major cause of death. Remarkable progress has been made in the description of the clinical and genetic spectrum of these diseases since the 1990's. Until now, precise phenotype/genotype relations remain elusive. As for several other neuromuscular disorders, apart from symptomatic treatments, there is currently no specific treatment to prevent or slow down the progression of the disease. The OPALE registry is a multicentre web-based registry dedicated to laminopathy and emerinopathy French patients. OPALE has been approved by ethical and regulatory authorities. Its main inclusion criteria is the presence of a proven pathogenic LMNA and/or EMD gene mutation.

The OPALE objectives are to provide a tool allowing detailed capture of patient genetic, neurological, cardiological, endocrinological and respiratory assessments, in order to allow i) precise disease natural history, ii) evaluation of different disease complication frequency and iii) identification of prognosis factors.

ReferenceCitation: Wahbi K, Ben Yaou R, Gandjbakhch E, Anselme F, Gossios T, Lakdawala NK, Stalens C, Sacher F, Babuty D, Trochu JN, Moubarak G, Savvatis K, Porcher R, Laforêt P, Fayssoil A, Marijon E, Stojkovic T, Béhin A, Leonard-Louis S, Sole G, Labombarda F, Richard P, Metay C, Quijano-Roy S, Dabaj I, Klug D, Vantyghem MC, Chevalier P, Ambrosi P, Salort E, Sadoul N, Waintraub X, Chikhaoui K, Mabo P, Combes N, Maury P, Sellal JM, Tedrow UB, Kalman JM, Vohra J, Androulakis AFA, Zeppenfeld K, Thompson T, Barnerias C, Bécane HM, Bieth E, Boccara F, Bonnet D, Bouhour F, Boulé S, Brehin AC, Chapon F, Cintas P, Cuisset JM, Davy JM, De Sandre-Giovannoli A, Demurger F, Desguerre I, Dieterich K, Durigneux J, Echaniz-Laguna A, Eschalier R, Ferreiro A, Ferrer X, Francannet C, Fradin M, Gaborit B, Gay A, Hagège A, Isapof A, Jeru I, Juntas Morales R, Lagrue E, Lamblin N, Lascols O, Laugel V, Lazarus A, Leturcq F, Levy N, Magot A, Manel V, Martins R, Mayer M, Mercier S, Meune C, Michaud M, Minot-Myhié MC, Muchir A, Nadaj-Pakleza A, Péréon Y, Petiot P, Petit F, Praline J, Rollin A, Sabouraud P, Sarret C, Schaeffer S, Taithe F, Tard C, Tiffreau V, Toutain A, Vatier C, Walther-Louvier U, Eymard B, Charron P, Vigouroux C, Bonne G, Kumar S, Elliott P, Duboc D. Development and Validation of a New Risk Prediction Score for Life-Threatening Ventricular Tachyarrhythmias in Laminopathies. Circulation. 2019 Jul 23;140(4):293-302. doi: 10.1161/CIRCULATIONAHA.118.039410. Epub 2019 Jun 3.

lead_sponsor: Pitié-Salpêtrière Hospital

location_facility: Centre de référence maladies neuromusculaires,CHU d'Angers

location_facility: Service d'endocrinologie, diabétologie et endocrinologie de la reproduction, Hôpital Saint Antoine

location_facility: Centre de référence des maladies neuromusculaires Ile de France, Hôpital Raymond Poincaré

location_facility: Centre de référence maladies neuromusculaires ile de France, GH Pitié-Salpêtrière

location_facility: Centre de référence maladies neuromusculaires ile de France, Hôpital Necker Enfants malades

location_facility: Centre de référence des maladies neuromusculaires, CHRU Lille

location_facility: Centre de référence maladies neuromusculaires ile de France, Hôpital Armand Trousseau

location_facility: Centre de référence des maladies neuromusculaires, CHU Lyon


title: New Therapeutic Strategy in ALS Based on Metabolic Status and Associated Metabolic Pathways.

acronym: METABOCALS

summary: Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that affects central and peripheral motor neurons. None of the clinical trials conducted have been clearly successful and the disease remains incurable, putting patients' vital prognosis at risk in the medium term. An alteration of the basal metabolism leading to hypermetabolism has been described in several articles in the literature. The causes of this hypermetabolism and the precise exploration of the metabolic pathways involved are still poorly understood. The fibroblasts of ALS patients may be the site of some metabolic disturbances in this disease with a hypothetical specific basal metabolic profile. These cells are adapted to different metabolic explorations such as omnic approaches. Superficial skin biopsy followed by fibroblast culture can provide a considerable biobank. This cellular richness will allow us, in ALS patients and their controls, to perform metabolomic and lipidomic approaches, as well as the quantification transcriptomic approach."

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Tours

location_facility: Neurology Department, University Hospitla, Tours

location_facility: Neurology Department, University Hospital, Limoges


title: Assessment of Tele-expertise for Second Medical Opinion on Pathological Diagnosis

summary: The purpose of this study is to determine whether digitalizing pathological slides and let it accessible on a server for a second medical opinion (tele-expertise) would reduce the time to diagnosis.

ReferenceCitation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.

ReferenceCitation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.

location_facility: Centre Hospitalier de Villeneuve Saint Georges


title: Randomized Clinical Trial of Plasma Exchanges Versus Sham Plasma Exchanges in Disabling Multiple Sclerosis Acute Relapses Refractory to Steroid Treatment

acronym: PLASMASEP

summary: In more than 40 % of multiple sclerosis (MS) patients experiencing relapse, residual disability accumulates in spite of steroid treatment. Plasma exchanges are frequently used but there is no established evidence of their efficacy.

location_facility: Service de neurologie - CHU de Clermont-Ferrand

location_facility: Service de Neurologie - CHU de Starsbourg

location_facility: Service de Neurologie - Hôpital Pellegrin - CHU de Bordeaux


title: Prospective, Multicenter, Clinical and Biological Database Set-up in Colon Cancer and Colic Tumors

acronym: BCBCOLON

summary: Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.

location_facility: Institut Régional du cancer de Montpellier


title: Tolerance Checkpoints Upon the B-cell Depletion Plus BAFF Blockade Strategy in Immune Thrombocytopenia (ITP) and Systemic Lupus Erythematosus (SLE) (Checkpoints ITP and SLE)

acronym: ITP&SLE

summary:
The aim of this proposal is to test if anti-BAFF antibody can restore a normal threshold of tolerance in patients in two auto-immune diseases along the RITUX-PLUS study in immune thrombocytopenia, and along the Believe study in SLE. This work would help to conclude whether or not the 'double hit' therapy may help to reset the immune system toward a more tolerogenic profile.

The aim is to compare the polyreactivity and autoreactivity, of immature (central tolerance) and naïve B cells (peripheral tolerance) in the peripheral blood along the RITUX-PLUS STUDY and the BLISS BELIEVE study after treatment (B-cell reconstitution time).

location_facility:
Henri Mondor Hospital
Pitie Salpetriere Hospital


title: The Importance of the Nurse's Role in Treatment Observance and Social Autonomy in Schizophrenia Using an Innovating Tool for Daily Transports: a Pilot Study

acronym: Schizovirt

summary:
Schizophrenia is a mental health issue that affects mostly young adults. The main symptoms are hallucinations, delirium, and agitation, poor social relations, lack of motivation, thought disorganization. Also, patients suffering from schizophrenia encounter important cognitive disorders affecting memory, executive functioning and attention. These cognitive alterations are often linked to social exclusion and stigmatisation.

Antipsychotic treatments are effective mainly on the positive dimension of symptoms (hallucinations etc…); however their action is very limited on the cognitive difficulties encountered. Psychosocial techniques can be used to treat the cognitive symptoms, such as cognitive remediation or psychosocial rehabilitation .

These cognitive difficulties mainly have an impact on patients' daily life, affecting their abilities to drive, for example. Schizophrenic patients suffer more road accidents than healthy subjects .

Thus, considering this information, it appears important to us to address this driving problem for various reasons:

Firstly, knowing how to drive is often linked to daily autonomy,
Secondly, driving is also linked to keeping an active social network and to work.

Patients suffering from schizophrenia often encounter difficulties in learning how to drive which reinforces the stigmatisation and fear of failure.

Thus, a specific driving and theory training prior to driving lessons could be a way of helping patients in their cognitive difficulties and pass their driving test. Daily transports mobilize a number of cognitive functions (attentional vigilance, working memory, psychomotor coordination, divided attention, visuo-spatial abilities .

Using a driving virtual reality tool could constitute an ecological cognitive remediation tool, by simulating daily driving situations. This "serious game" approach enables us to involve virtual reality in training but also in assessments. The driving simulator allows standardized evaluations and could also become a therapeutic tool of ecological cognitive remediation.

This study thus appears interesting in order to develop road safety and daily autonomy.

lead_sponsor: Hôpital le Vinatier

location_facility:
Hôpital le vinatier
Hopital Vinatier


title: Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study

acronym: Tapas

summary:
The primary purpose of TAPAS study is to demonstrate the superiority of analgesic effect of trans abdominal plane block (TAP block) performed at the beginning of stoma reversal, compared to standard of care.

The hypothesize is that a TAP block performed at the beginning of surgery of stoma reversal would improve patient's satisfaction (evaluated by Quo-r40 questionnaire), would reduce the incidence of post operative pain, time spent in recovery room, and reduce hospitalisation time

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU
CHU Rennes


title: Phase II/III Double-blind Randomized Placebo-controlled Trial Assessing the Preventive Effect of Clopidogrel on the Systemic Sclerosis Development Risk in Subjects With Specific Dysimmunity and Raynaud Phenomenon

acronym: PSSIT

summary: Systemic sclerosis (SSc) is a severe autoimmune disease associating dysimmunity, vasculopathy and fibrosis. No curative treatment is available. Pre-clinical abnormalities can be found such as specific autoantibodies. The association of Raynaud phenomenon and SSc-specific anti-nuclear antibodies is the hallmark of pre-scleroderma subjects, among who around 47% declare a complete disease after five years. The aim of this study is to assess in this particular population the preventive effect of an anti-platelet treatment.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Montpellier - service de médecine vasculaire

location_facility: CH de Mont-de-Marsan - service de rhumatologie

location_facility: AP-HP - Hôpital Cochin - service de médecine interne

location_facility: CHU de Limoges - Service de médecine interne

location_facility: CH de Libourne - service de rhumatologie

location_facility: CHU de Bordeaux - service de rhumatologie

location_facility: CHU de Toulouse - service de médecine interne


title: Assessment of a Novel Method for Non-invasive Sampling of the Distal Airspace in Acute Respiratory Distress Syndrome Patients Receiving Inhaled Sedation With Sevoflurane)

acronym: ANAISS

summary:
The main objective of this study is to compare the protein composition of simultaneously collected undiluted pulmonary edema fluid and AnaConDa-S ® fluid from patients with ARDS.

In a previous pilot randomized controlled trial, in patients with moderate-severe acute respiratory distress syndrome (ARDS), the use of inhaled sevoflurane improved oxygenation and decreased levels of a marker of lung epithelial injury (soluble receptor for advanced glycation end-products, sRAGE) and of some inflammatory markers (interleukin (IL)-1β, IL-6, IL-8 and tumor necrosis factor (TNF)-α), compared to intravenous midazolam. These results reinforce those from previously published preclinical studies as they suggest a protective effect of sevoflurane from alveolar/systemic inflammation and from reduced epithelial injury and/or improved alveolar fluid clearance, as assessed by plasma soluble receptor for advanced glycation end-products (sRAGE). The results from available studies support the safe use of sevoflurane inhalation through dedicated device is well tolerated, with no major adverse effect, e.g. on renal function or respiratory mechanics, in critically ill patients admitted to the intensive care unit (ICU), including those with ARDS.

Because the investigators group frequently uses sevoflurane in patients with ARDS and are interested in developing further research on the effects of inhaled sedation in ARDS, the current study has been designed to verify whether the same concept could be applied to the filter the investigators use to vaporize sevoflurane in their ICUs.

status: Withdrawn


title: Allogeneic Stem Cell Transplantation of CordIn™, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients With Hemoglobinopathies

lead_sponsor: Gamida Cell ltd

location_country:
United States
France

location_facility:
UCSF Benioff Children's Hospital
Hôpital Robert Debré
Children's National

summary: CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells. The overall study objectives are to evaluate the safety and efficacy of CordIn™.