title: Impact of Nasal High-flow vs Venturi Mask Oxygen Therapy on Weaning Outcome: a Multicenter, Randomized, Controlled Trial

acronym: RINO

summary: The purpose of this study is to determine whether, as compared with the Venturi mask, a nasal, high-flow oxygenation device (Optiflow) may reduce the extubation failure rate in patients needing oxygen therapy after extubation.

ReferenceCitation: Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.

ReferenceCitation: Chaudhuri D, Granton D, Wang DX, Einav S, Helviz Y, Mauri T, Ricard JD, Mancebo J, Frat JP, Jog S, Hernandez G, Maggiore SM, Hodgson C, Jaber S, Brochard L, Burns KEA, Rochwerg B. Moderate Certainty Evidence Suggests the Use of High-Flow Nasal Cannula Does Not Decrease Hypoxia When Compared With Conventional Oxygen Therapy in the Peri-Intubation Period: Results of a Systematic Review and Meta-Analysis. Crit Care Med. 2020 Apr;48(4):571-578. doi: 10.1097/CCM.0000000000004217.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Catholic University of the Sacred Heart

sponsor_collaborators:
Catholic University of the Sacred Heart
Fisher and Paykel Healthcare

location_country: Italy Greece Spain France

location_facility: Catholic University of the Sacred Heart, A. Gemelli Hospital

location_facility: Università del Piemonte Orientale, Sant'Andrea Hospital

location_facility: La Pitie-Salpetriere University Hospital

location_facility: Università del Piemonte Orientale, Ospedale della Carità


type: EudraCT Number

title: A Prospective Randomized Multicenter Study Comparing Horse Antithymocyte Globuline (hATG) + Cyclosporine A (CsA) With or Without Eltrombopag as Front-line Therapy for Severe Aplastic Anemia Patients.

acronym: RACE

summary: The null hypothesis of no difference in CR% at 3 months between the arms will be tested against the alternative of a difference in CR% at an alpha level of .05 by assessing the odds ratio for arm yielded by this model.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Peffault de Latour R, Kulasekararaj A, Iacobelli S, Terwel SR, Cook R, Griffin M, Halkes CJM, Recher C, Barraco F, Forcade E, Vallejo JC, Drexler B, Mear JB, Smith AE, Angelucci E, Raymakers RAP, de Groot MR, Daguindau E, Nur E, Barcellini W, Russell NH, Terriou L, Iori AP, La Rocca U, Sureda A, Sanchez-Ortega I, Xicoy B, Jarque I, Cavenagh J, Sicre de Fontbrune F, Marotta S, Munir T, Tjon JML, Tavitian S, Praire A, Clement L, Rabian F, Marano L, Hill A, Palmisani E, Muus P, Cacace F, Frieri C, van Lint MT, Passweg JR, Marsh JCW, Socie G, Mufti GJ, Dufour C, Risitano AM; Severe Aplastic Anemia Working Party of the European Society for Blood and Marrow Transplantation. Eltrombopag Added to Immunosuppression in Severe Aplastic Anemia. N Engl J Med. 2022 Jan 6;386(1):11-23. doi: 10.1056/NEJMoa2109965.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: Tor Vergata University - Cineca Institutional Research Information System

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

collaborators: Novartis Pfizer

location_country:
Italy
United Kingdom
Netherlands
Switzerland
Spain
France

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: AOU Città della Salute e della Scienza di Torino

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Medico-economic Evaluation of the Management of Weight Regain After Gastric Bypass by Gastrointestinal Narrowing of Jejunal Anastomosis by Endoscopic Suturing: Apollo Endosurgery OverStitch Technical

summary: Prospective multicenters randomized study to compare the efficiency and the socioeconomic impact of the endoscopic management (Overstitch technique) of weight regain after gastric bypass surgery to non invasive treatment

status: Terminated

lead_sponsor: University Hospital, Montpellier

location_facility:
Louis Mourier Hospital
Strasbourg Hospital
HEGP Hospital
Villeurbanne clinic
Montpellier Hospital
Lille Hospital
Nice Hospital

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: Therapeutic Strategies Including Avastin as 1st Line Therapy in Elderly Patients Suffering From Advanced (IIIB/IV Stage) Non-squamous Non-small Cell Lung Cancer, in Routine Clinical Practice.

summary: This prospective, observational study will assess the effectiveness and safety of Avastin (bevacizumab) as 1st line therapy in elderly patients with advanced non-squamous non-small cell lung cancer in clinical practice. Therapy with Avastin and standard chemotherapy will be administered according to the treating physician. Data will be collected for approximately 4 years.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Hoffmann-La Roche

location_facility: Chi Alpes Du Sud Site De Gap; Pneumologie

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Hopital Calmette; Pneumologie Oncologie Ouest

location_facility: Centre Hospitalier Alpes Leman CHAL;Pneumologie

location_facility: Centre Oscar Lambret; Chir Cancerologie General

location_facility: Hopital Saint Vincent; Consult et Explorations

location_facility: Hopital Du Cluzeau; Service de Pathologie Respiratoire

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Centre Hospitalier François Quesnay; Pneumologie-Neurologie

location_facility: Gh Mutualiste Les Portes Du Sud; Pneumologie

location_facility: Ch De Rambouillet; Pneumologie Cardiologie

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: Clinique sainte marie; chimiotherapie ambulatoire

location_facility: Hopital Louis Pasteur; Pneumologie Tabacologie

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Chi Emile Durkheim Site Epinal; Pneumologie

location_facility: Centre Medical National Mgen; Pneumologie

location_facility: CH Du Cotentin Site De Cherbourg; Hopital De Jour

location_facility: Hopital Gabriel Montpied; Service de Pneumologie

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Hopital Bel Air; Pneumologie Allergologie

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Hopitaux Du Leman Site Thonon; Pneumologie

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Centre Cardiologique Du Nord; Pneumologie

location_facility: Groupe Oncorad Garonne; Unite Onco Hematologie

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

location_facility: Clinique Saint Hilaire; Sce Chimiotherapie

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: Centre Hospitalier Lyon Sud; Pneumologie


title: Duration of Mechanical Ventilation and Mortality Among Brain-injured Patients - a Before-after Evaluation of a Quality Improvement Project

acronym: BI-VILI

summary:
Protective ventilation (association of a tidal volume < 8 ml/kg with a positive end expiratory pressure) is poorly used in severe brain-injured patients. Moreover, a systematic approach to extubation may decrease the rate of extubation failure and enhance outcomes of brain-injured patients.

We hypothesized that medical education and implementation of an evidence-base care bundle associating protective ventilation and systemic approach to extubation can reduce the duration of mechanical ventilation in brain-injured patients.

ReferenceCitation: Asehnoune K, Mrozek S, Perrigault PF, Seguin P, Dahyot-Fizelier C, Lasocki S, Pujol A, Martin M, Chabanne R, Muller L, Hanouz JL, Hammad E, Rozec B, Kerforne T, Ichai C, Cinotti R, Geeraerts T, Elaroussi D, Pelosi P, Jaber S, Dalichampt M, Feuillet F, Sebille V, Roquilly A; BI-VILI study group. A multi-faceted strategy to reduce ventilation-associated mortality in brain-injured patients. The BI-VILI project: a nationwide quality improvement project. Intensive Care Med. 2017 Jul;43(7):957-970. doi: 10.1007/s00134-017-4764-6. Epub 2017 Mar 18.

oa_host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_normalized: HAL

version: submittedVersion

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ParisTech

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Springer-Nature

lead_sponsor: Nantes University Hospital

location_facility: Tours University Hospital - Neurotrauma ICU

location_facility: Tours Univeristy Hospital - Neurosurgery ICU

intervention_type: Other


title: GASTRICHIP : D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma. A Randomized and Multicentric Phase III Study.

acronym: GASTRICHIP

summary:
A prospective, opened, multicentric, randomised, phase III trial with two arms:

Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin
Arm B: curative gastrectomy with D1-D2 lymph node dissection

Main objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Glehen O, Passot G, Villeneuve L, Vaudoyer D, Bin-Dorel S, Boschetti G, Piaton E, Garofalo A. GASTRICHIP: D2 resection and hyperthermic intraperitoneal chemotherapy in locally advanced gastric carcinoma: a randomized and multicenter phase III study. BMC Cancer. 2014 Mar 14;14:183. doi: 10.1186/1471-2407-14-183.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: Hospices Civils de Lyon

location_country: Spain France

location_facility: Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy

location_facility: Service de Chirurgie Viscérale, CLCC François Baclesse

location_facility: Service de Chirurgie Générale et Viscérale, CHU de Reims - Hôpital Robert Debré

location_facility: Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

location_facility: Service de Chirurgie Digestive Oncologique, CLCC Paul Papin

location_facility: Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin

location_facility: Service de Chirurgie Digestive, Hôpital Lariboisière

location_facility: Département de Chirurgie Digestive, CHU d'Amiens

location_facility: Service de Chirurgie Viscérale et Oncologique, Hôpital Saint-Louis

location_facility: Service de Chirurgie Digestive, Institut Curie

location_facility: Service de Chirurgie Digestive et de Physiologie Digestive, Hôpital Ch. Nicolle

location_facility: Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre

location_facility: Service de Chirurgie Viscérale, CHU de Poitiers

location_facility: Service de Chirurgie Digestive et Générale, Hôpital Huriez

location_facility: Service de Chirurgie Digestive, Hôpital du Bocage

location_facility: Service de Chirurgie Générale et Digestive, Hôpital Saint-Antoine, APHP

location_facility: Département de Chirurgie Digestive - CHU d'Angers

location_facility: Service de Chirurgie Digestive, CLCC Léon Bérard

location_facility: Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon

location_facility: Service d'Oncologie Digestive, Hôpital de la Timone

location_facility: Service de Chirurgie Générale et Digestive, Hôpital Purpan

location_facility: Service de Chirurgie Digestive, CRLC Val d'Aurelle

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

location_facility: Hospital Universitario Principe de Asturias

location_facility: Service de Chirurgie Digestive, Hôpital Archet II

location_facility: Service de Chirurgie Viscérale, CHU Estaing

location_facility: Service de Chirurgie Digestive, Hôpital Nord

location_facility: Service de Chirurgie Digestive, CLCC René Gauducheau

status_simplified: Ongoing


type: Other Grant/Funding Number

title: A European Multicentre Double-blind Placebo-controlled Phase III Trial of Nilvadipine in Mild to Moderate Alzheimer's Disease

acronym: NILVAD

summary:
Alzheimer's disease (AD) is an ever-increasing public health concern among the aging population and is the most common form of dementia affecting more than 15 million individuals worldwide and around 5 million Europeans. The direct and indirect costs of AD and other dementias amount to more than €440,000 million each year (www.alz.org, 2010).

Even modest therapeutic advances that delay disease onset and progression could significantly reduce the global burden of the disease and the level of care required by patients. While there are symptomatic-based drug therapies available for AD, these medications do not prevent the disease process itself. There is therefore an imperative to develop new treatments for AD that have disease modifying effects. This double-blind placebo controlled study will test the efficacy and safety of nilvadipine in 500 subjects with mild to moderate AD over a treatment period of 18 months. There is a strong scientific rationale for this study: Nilvadipine, a licensed calcium channel enhances Aß clearance from brain and restores cortical perfusion in mouse models of AD. Nilvadipine is safe and well tolerated in AD patients and clinical studies with this medication have shown stabilization of cognitive decline and reduced incidence of AD, pointing to both symptomatic and disease modifying benefits. Male and female patients with mild to moderate AD aged between 50 and 90 with a range of medical morbidities and frailty will be included in the study. If this trial is successful, nilvadipine would represent an advance in the treatment of AD patients and would have a major impact on the health and social care costs incurred in Europe by this neurodegenerative disorder. Furthermore, the creation of the NILVAD network will support future clinical trials and research innovation in AD across Europe.

ReferenceType: background

ReferenceCitation: Brogden RN, McTavish D. Nilvadipine. A review of its pharmacodynamic and pharmacokinetic properties, therapeutic use in hypertension and potential in cerebrovascular disease and angina. Drugs Aging. 1995 Feb;6(2):150-71. doi: 10.2165/00002512-199506020-00007. Erratum In: Drugs Aging 1995 Aug;7(2):116.

ReferenceCitation: Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

ReferenceCitation: Facchinetti F, Fasolato C, Del Giudice E, Burgo A, Furegato S, Fusco M, Basso E, Seraglia R, D'Arrigo A, Leon A. Nimodipine selectively stimulates beta-amyloid 1-42 secretion by a mechanism independent of calcium influx blockage. Neurobiol Aging. 2006 Feb;27(2):218-27. doi: 10.1016/j.neurobiolaging.2005.02.006.

ReferenceCitation: Fleckenstein A. Specific pharmacology of calcium in myocardium, cardiac pacemakers, and vascular smooth muscle. Annu Rev Pharmacol Toxicol. 1977;17:149-66. doi: 10.1146/annurev.pa.17.040177.001053. No abstract available.

ReferenceCitation: Forette F, Seux ML, Staessen JA, Thijs L, Birkenhager WH, Babarskiene MR, Babeanu S, Bossini A, Gil-Extremera B, Girerd X, Laks T, Lilov E, Moisseyev V, Tuomilehto J, Vanhanen H, Webster J, Yodfat Y, Fagard R. Prevention of dementia in randomised double-blind placebo-controlled Systolic Hypertension in Europe (Syst-Eur) trial. Lancet. 1998 Oct 24;352(9137):1347-51. doi: 10.1016/s0140-6736(98)03086-4.

ReferenceCitation: Forette F, Seux ML, Staessen JA, Thijs L, Babarskiene MR, Babeanu S, Bossini A, Fagard R, Gil-Extremera B, Laks T, Kobalava Z, Sarti C, Tuomilehto J, Vanhanen H, Webster J, Yodfat Y, Birkenhager WH; Systolic Hypertension in Europe Investigators. The prevention of dementia with antihypertensive treatment: new evidence from the Systolic Hypertension in Europe (Syst-Eur) study. Arch Intern Med. 2002 Oct 14;162(18):2046-52. doi: 10.1001/archinte.162.18.2046. Erratum In: Arch Intern Med. 2003 Jan 27;163(2):241.

ReferenceCitation: Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

ReferenceCitation: Furuichi Y, Takakura S, Satoh H, Mori J, Kohsaka M. The effect of nilvadipine, a dihydropyridine type calcium channel blocker, on local cerebral blood flow in rats. Jpn J Pharmacol. 1992 Apr;58(4):457-60. doi: 10.1254/jjp.58.457.

ReferenceCitation: Gelinas I, Gauthier L, McIntyre M, Gauthier S. Development of a functional measure for persons with Alzheimer's disease: the disability assessment for dementia. Am J Occup Ther. 1999 Sep-Oct;53(5):471-81. doi: 10.5014/ajot.53.5.471.

ReferenceCitation: Hanyu H, Hirao K, Shimizu S, Sato T, Kiuchi A, Iwamoto T. Nilvadipine prevents cognitive decline of patients with mild cognitive impairment. Int J Geriatr Psychiatry. 2007 Dec;22(12):1264-6. doi: 10.1002/gps.1851. No abstract available.

ReferenceCitation: Inouye M, Mio T, Sumino K. Nilvadipine protects low-density lipoprotein cholesterol from in vivo oxidation in hypertensive patients with risk factors for atherosclerosis. Eur J Clin Pharmacol. 2000 Apr;56(1):35-41. doi: 10.1007/s002280050717.

ReferenceCitation: Khachaturian AS, Zandi PP, Lyketsos CG, Hayden KM, Skoog I, Norton MC, Tschanz JT, Mayer LS, Welsh-Bohmer KA, Breitner JC. Antihypertensive medication use and incident Alzheimer disease: the Cache County Study. Arch Neurol. 2006 May;63(5):686-92. doi: 10.1001/archneur.63.5.noc60013. Epub 2006 Mar 13.

ReferenceCitation: Kagawa H, Nomura S, Ozaki Y, Nagahama M, Fukuhara S. Effects of nilvadipine on cytokine-levels and soluble factors in collagen disease complicated with essential hypertension. Clin Exp Hypertens. 1999 Oct;21(7):1177-88. doi: 10.3109/10641969909052196.

ReferenceCitation: Lopez-Arrieta JM, Birks J. Nimodipine for primary degenerative, mixed and vascular dementia. Cochrane Database Syst Rev. 2002;(3):CD000147. doi: 10.1002/14651858.CD000147.

ReferenceCitation: Lubben J, Blozik E, Gillmann G, Iliffe S, von Renteln Kruse W, Beck JC, Stuck AE. Performance of an abbreviated version of the Lubben Social Network Scale among three European community-dwelling older adult populations. Gerontologist. 2006 Aug;46(4):503-13. doi: 10.1093/geront/46.4.503.

ReferenceCitation: Maxwell CJ, Hogan DB, Ebly EM. Calcium-channel blockers and cognitive function in elderly people: results from the Canadian Study of Health and Aging. CMAJ. 1999 Sep 7;161(5):501-6. Erratum In: CMAJ 1999 Nov 30;161(11):1396.

ReferenceCitation: McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. doi: 10.1212/wnl.34.7.939.

ReferenceCitation: Mohs RC, Rosen WG, Davis KL. The Alzheimer's disease assessment scale: an instrument for assessing treatment efficacy. Psychopharmacol Bull. 1983;19(3):448-50. No abstract available.

ReferenceCitation: Molloy DW, Standish TI. A guide to the standardized Mini-Mental State Examination. Int Psychogeriatr. 1997;9 Suppl 1:87-94; discussion 143-50. doi: 10.1017/s1041610297004754.

ReferenceCitation: Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.

ReferenceCitation: Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159.

ReferenceCitation: Ogasawara K, Noda A, Yasuda S, Kobayashi M, Yukawa H, Ogawa A. Effect of calcium antagonist on cerebral blood flow and oxygen metabolism in patients with hypertension and chronic major cerebral artery occlusion: a positron emission tomography study. Nucl Med Commun. 2003 Jan;24(1):71-6. doi: 10.1097/00006231-200301000-00017.

ReferenceCitation: Ohtsuka M, Ono T, Hiroi J, Esumi K, Kikuchi H, Kumada S. Comparison of the cardiovascular effect of FR34235, a new dihydropyridine, with other calcium antagonists. J Cardiovasc Pharmacol. 1983 Nov-Dec;5(6):1074-82. doi: 10.1097/00005344-198311000-00024.

ReferenceCitation: Parry SW, Steen N, Baptist M, Fiaschi KA, Parry O, Kenny RA. Cerebral autoregulation is impaired in cardioinhibitory carotid sinus syndrome. Heart. 2006 Jun;92(6):792-7. doi: 10.1136/hrt.2004.053348. Epub 2006 Jan 31.

ReferenceCitation: Rosenthal J. Nilvadipine: profile of a new calcium antagonist. An overview. J Cardiovasc Pharmacol. 1994;24 Suppl 2:S92-107.

ReferenceCitation: Shimamoto H, Shimamoto Y. Nilvadipine increases cerebral blood flow in elderly hypertensives: comparison with nifedipine. J Hum Hypertens. 1995 Apr;9(4):271-9.

ReferenceCitation: Tollefson GD. Short-term effects of the calcium channel blocker nimodipine (Bay-e-9736) in the management of primary degenerative dementia. Biol Psychiatry. 1990 May 15;27(10):1133-42. doi: 10.1016/0006-3223(90)90050-c.

ReferenceCitation: Verghese J, Lipton RB, Katz MJ, Hall CB, Derby CA, Kuslansky G, Ambrose AF, Sliwinski M, Buschke H. Leisure activities and the risk of dementia in the elderly. N Engl J Med. 2003 Jun 19;348(25):2508-16. doi: 10.1056/NEJMoa022252.

ReferenceCitation: Yasar S, Corrada M, Brookmeyer R, Kawas C. Calcium channel blockers and risk of AD: the Baltimore Longitudinal Study of Aging. Neurobiol Aging. 2005 Feb;26(2):157-63. doi: 10.1016/j.neurobiolaging.2004.03.009.

ReferenceCitation: Dyer AH, Lawlor B, Kennelly SP; NILVAD Study Group. Gait speed, cognition and falls in people living with mild-to-moderate Alzheimer disease: data from NILVAD. BMC Geriatr. 2020 Mar 30;20(1):117. doi: 10.1186/s12877-020-01531-w.

repository_institution: Radboud University - Radboud Repository

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

repository_institution: University College Cork, Ireland - Cork Open Research Archive

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Abdullah L, Crawford F, Tsolaki M, Borjesson-Hanson A, Olde Rikkert M, Pasquier F, Wallin A, Kennelly S, Ait-Ghezala G, Paris D, Hendrix S, Blennow K, Lawlor B, Mullan M. The Influence of Baseline Alzheimer's Disease Severity on Cognitive Decline and CSF Biomarkers in the NILVAD Trial. Front Neurol. 2020 Mar 6;11:149. doi: 10.3389/fneur.2020.00149. eCollection 2020.

ReferenceCitation: de Heus RAA, Olde Rikkert MGM, Tully PJ, Lawlor BA, Claassen JAHR; NILVAD Study Group. Blood Pressure Variability and Progression of Clinical Alzheimer Disease. Hypertension. 2019 Nov;74(5):1172-1180. doi: 10.1161/HYPERTENSIONAHA.119.13664. Epub 2019 Sep 23.

ReferenceCitation: de Jong DLK, de Heus RAA, Rijpma A, Donders R, Olde Rikkert MGM, Gunther M, Lawlor BA, van Osch MJP, Claassen JAHR. Effects of Nilvadipine on Cerebral Blood Flow in Patients With Alzheimer Disease. Hypertension. 2019 Aug;74(2):413-420. doi: 10.1161/HYPERTENSIONAHA.119.12892. Epub 2019 Jun 17.

ReferenceCitation: de Heus RAA, Donders R, Santoso AMM, Olde Rikkert MGM, Lawlor BA, Claassen JAHR; Nilvad Study Group. Blood Pressure Lowering With Nilvadipine in Patients With Mild-to-Moderate Alzheimer Disease Does Not Increase the Prevalence of Orthostatic Hypotension. J Am Heart Assoc. 2019 May 21;8(10):e011938. doi: 10.1161/JAHA.119.011938.

repositories:
PubMed Central
UCL Discovery
repository.ubn.ru.nl

ReferenceCitation: Lawlor B, Segurado R, Kennelly S, Olde Rikkert MGM, Howard R, Pasquier F, Borjesson-Hanson A, Tsolaki M, Lucca U, Molloy DW, Coen R, Riepe MW, Kalman J, Kenny RA, Cregg F, O'Dwyer S, Walsh C, Adams J, Banzi R, Breuilh L, Daly L, Hendrix S, Aisen P, Gaynor S, Sheikhi A, Taekema DG, Verhey FR, Nemni R, Nobili F, Franceschi M, Frisoni G, Zanetti O, Konsta A, Anastasios O, Nenopoulou S, Tsolaki-Tagaraki F, Pakaski M, Dereeper O, de la Sayette V, Senechal O, Lavenu I, Devendeville A, Calais G, Crawford F, Mullan M; NILVAD Study Group. Nilvadipine in mild to moderate Alzheimer disease: A randomised controlled trial. PLoS Med. 2018 Sep 24;15(9):e1002660. doi: 10.1371/journal.pmed.1002660. eCollection 2018 Sep.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Limerick - University of Limerick Institutional Repository

repository_institution: Dublin Institute of Technology - Arrow@dit

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repositories_institution: Dublin Institute of Technology - Arrow@dit

repositories_institution: University of Illinois at Chicago - INDIGO

collaborators: Istituto Di Ricerche Farmacologiche Mario Negri

location_country:
Germany
Ireland
Italy
Hungary
United Kingdom
Sweden
Netherlands
Greece
France

location_facility: Centre Hospitalier Universitaire de Calais (CHU Calais)

location_facility: Centre Hospitalier Universitaire de Lens (CHU Lens)

location_facility: Centre Hospitalier Regional et Universitaire de Lille (CHRU Lille)

location_facility: Centre Hospitalier Universitaire d'Amiens (CHU Amiens)

location_facility: Centre Hospitalier Universitaire de Caen (CHU Caen)

location_facility: Centre Hospitalier Universitaire de Saint Philibert (GHICL)

location_facility: Centre Hospitalier Universitaire de Bethune (CH Bethune)


acronym: NeuroSenSS

summary:
Primary Sjögren syndrome (pSS) is an inflammatory, autoimmune, multiorgan disease often involving the central and peripheral nervous systems. Fifteen to twenty percent of patients with the primary Sjögren's syndrome have neurological complications involving the peripheral nervous system. Although some patients have large fiber neuropathy, around forty percent of patients with Sjögren's syndrome experience neuropathic pain with normal electrodiagnostic studies. Although these patients may be diagnosed with fibromyalgia or depressive symptoms, some have been shown to have small fiber neuropathy (SFN). A recent study proved that more than 90% of pSS patients with such neuropathic pain have SFN {Fauchais, 2010 #188}.

The aim of this study will be to investigate the occurrence of small fiber neuropathy in patients with pSS and neuropathic pain with normal electromyographic studies and to determine the existence of a conjoint local inflammatory process mediated by cellular, cytokinic or auto-antibody response. Quantification of epidermal nerve fiber density after skin biopsy is a valuable tool to diagnose small fiber neuropathy and the method has been widely validated. A skin biopsy will be performed in patients and control and will allow quantification of small fiber density in skin sample along with measurement of sweat gland innervation. Moreover, pathophysiological studies will be carried on in order to evaluate the causal relationship between cellular and humoral inflammation and small fiberneuropathy.

Recent studies have pointed out the inconstant efficacy of both corticosteroid and immunosuppressive drugs in pSS-related SFN. Dissecting the molecular mechanisms of small fiber neuropathy in these patients may help designing new therapeutic strategies.

lead_sponsor: University Hospital, Limoges

location_facility:
CH d'Albi
University Hospital, Limoges
CHU Toulouse
CHU de Lille
CH de Brive
CHU Bordeaux
CH de Rodez


title: Prospective Multicentre Observational French Cohort Study of Patients With Heart Failure and Central Sleep Apnoea Requiring Adaptive Servo-Ventilation (PaceWave, AutoSet CS) Treatment

acronym: FACE

summary: The purpose of FACE study is to provide in routine practice complementary long-term data on the mortality and morbidity of Chronic Heart Failure (CHF) patients with Central Sleep Apnea eligible for Adaptative Servo-Ventilation (ASV) treatment (PaceWave, AutoSet CS; ResMed).

ReferenceCitation: Tamisier R, Damy T, Davy JM, Verbraecken JA, Bailly S, Lavergne F, Palot A, Goutorbe F, Pepin JL, d'Ortho MP. Cohort profile: FACE, prospective follow-up of chronic heart failure patients with sleep-disordered breathing indicated for adaptive servo ventilation. BMJ Open. 2020 Jul 19;10(7):e038403. doi: 10.1136/bmjopen-2020-038403.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories:
PubMed Central
irua

repositories_concat: PubMed Central;irua

publisher_dissemination: British Medical Journal

lead_sponsor: ResMed

location_facility: Arnaud de Villeneuve University Hospital

location_facility: APHP - Pitié-Salpêtrière University Hospital


type: Other Identifier

title: Etude Resume (Retraitement Sunitinib Rein Metastatique)

acronym: RESUME

summary: Retrospective and prospective study in mRCC patients treated with sutent in first line and rechallenged by Sutent in 3rd and 4th line.

time_perspective: Retrospective

lead_sponsor: Pfizer

location_facility: Institut Paoli-Calmettes / Hôpital de jour

location_facility: Departement d'Oncologie Medicale-Institut de Cancerologie de la Loire

location_facility: Centre Rene Gauducheau - Service Oncologie Medicale

location_facility: Centre Oscar Lambret - Cancérologie Urologie Digestive

location_facility: Centre Leon Berard, Service d'Oncologie Medicale


acronym: CUSTOMBONE

summary:
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™

The patients will be included as soon as they are implanted and follow-up for 2 years. It is observational so no specific exam is planned.

The explantation rate will be measured, that is to say the number of patients whose prosthesis will be removed (with or without any relationship with the implant or the procedure).

lead_sponsor: Integra LifeSciences Corporation

location_facility:
CH Amiens
CHU Lariboisière
CHU Beaujon
CHRU Roger Salengro
Hopital Maison Blanche
CH Bretonneau
CHU Hotel Dieu
CHU la cavale blanche
CHU Pasteur
CHU Hautepierre
CHU Henri Mondor
CHU La¨Pitié Salpêtrière
CHU Lyon
CH Saint Etienne
Clinique du Tonkin
Hôpital Ponchaillou
CH de la cote basque
CHU Angers

intervention_type: Procedure


title: A Multicenter, Open, Randomized, Controlled Phase IIb Trial Evaluating Efficacy and Tolerability of GRASPA (L-asparaginase Encapsulated in Red Blood Cells, Eryaspase) Plus Low-dose Cytarabine vs Low-dose Cytarabine Alone, in Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) Elderly Patients, Unfit for Intensive Chemotherapy

acronym: ENFORCE

summary: The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65 years diagnosed with AML and unfit for intensive chemotherapy.

ipd_sharing: Undecided

lead_sponsor: ERYtech Pharma

location_facility:
hopital de Perpignan
Centre Léon Bérard
Hopital Morvan
Chu D'Angers
Hôpital Claude-Huriez
Hopital de Hautepierre
Hôtel Dieu - CHU de NANTES
Hôpital Saint Eloi
Hopital Région d'Annecy
Hôpital JEAN MINJOZ
Hopital De Purpan CHU Toulouse
Hôpital l'Archet 1
Groupe Hospitalier Sud
CHRU de Nîmes
Institut Paoli Calmettes
CHU Estaing
Centre hospitalier Lyon Sud
Institut de Cancérologie de la Loire
Hopital de Brabois
Hôpital Haut-Lévèque
Centre Henri Becquerel


summary: This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until disease progression or inacceptable toxicity occurs, whichever comes first.

ReferenceCitation: Pivot X, Spano JP, Espie M, Cottu P, Jouannaud C, Pottier V, Moreau L, Extra JM, Lortholary A, Rivera P, Spaeth D, Attar-Rabia H, Benkanoun C, Dima-Martinez L, Esposito N, Gligorov J. Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study. Eur J Cancer. 2017 Sep;82:230-236. doi: 10.1016/j.ejca.2017.05.009. Epub 2017 Jun 23.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

location_facility: Pole Sante Republique;Oncologie Hematologie

location_facility: Polyclinique de la Cote Basque Sud; Oncologie

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: HOP Prive Arras Les Bonnettes; Chimiotherapie

location_facility: Centre Catherine de Sienne; Chimiotherapie

location_facility: Centre Hospitalier de La Cote Basque; Oncologie

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Chi De Cornouaille; Oncologie Hospitalisation

location_facility: Centre Oscar Lambret; Unite de Recherche Clinique

location_facility: HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune

location_facility: Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Clinique De La Sauvegarde; Chimiotherapie

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Hopital Belle Isle; Oncologie Hematologie

location_facility: Hopital Prive Nord Parisien; Soins De Suite - Oncologie

location_facility: CMCO De La Cote D Opale; Auberge De Jour

location_facility: Centre Eugene Marquis; Bureau D Etudes Cliniques

location_facility: Centre Hospitalier Universitaire de Poitiers

title: An Open-Label, Randomized, Multicenter Phase III Study in Patients With HER2-Positive Metastatic Breast Cancer Responding to First Line Treatment With Intravenous Trastuzumab for at Least 3 Years and Investigating Patient Preference for Subcutaneous Trastuzumab

source: euctr


title: Therapeutic Monitoring of Ceftriaxone, Prescribed at High Doses, in the Treatment of Meningitis and Others Neurological Infections.

summary: The aim of the study is to describe the concentrations of Ceftriaxone at the steady state, in patients treated for meningitis, to determine pharmacokinetic parameters at high dose in this population. Additionally, we aimed to detect adverse effect, especially neurological trouble related to Ceftriaxone toxicity.

primary_purpose: Health Services Research

ReferenceCitation: Gregoire M, Dailly E, Le Turnier P, Garot D, Guimard T, Bernard L, Tattevin P, Vandamme YM, Hoff J, Lemaitre F, Verdier MC, Deslandes G, Bellouard R, Sebille V, Chiffoleau A, Boutoille D, Navas D, Asseray N. High-Dose Ceftriaxone for Bacterial Meningitis and Optimization of Administration Scheme Based on Nomogram. Antimicrob Agents Chemother. 2019 Aug 23;63(9):e00634-19. doi: 10.1128/AAC.00634-19. Print 2019 Sep.

evidence: open (via free pdf)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

repositories_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

publisher_dissemination: American Society for Microbiology

location_facility:
Tours universitary hospital
St Nazaire hospital
Angers Universitary Hospital
Nantes Universitary Hospital
Poitiers Universitary hospital
La Roche/Yon hospital
Rennes Universitary hospital


title: Multicenter Clinical Study Assessing the Performance and the Safety of the Second Generation Antimicrobial Graft in Abdominal Position

acronym: SYNERGY

summary: Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.

lead_sponsor: Maquet Cardiovascular

location_country: Germany France

location_facility:
CHU Dupuytren
CHU La Milétrie
Hôpital G. et R. Laennec
Krankenhaus Nordwest
CHRU
Hôpital Edouard Herriot
Hôpital Pompidou
CHU Jean Minjoz


title: Multidimensional Evaluation of Pain in Rheumatoid Arthritis (Douleur PR)

acronym: Douleur-PR

summary:
Rheumatoid Arthritis (RA) is an inflammatory chronic rheumatism where the pain remains the priority domain of improvement for the patients instead a good control of the inflammatory disease by treatments, even biotherapeutics .

Some studies show that less than 50 % of the patients is satisfied by the care of the pain, whereas the criteria of evaluation of the RA improve under treatment. The chronic pain, is a complex and multifactorial subjective phenomenon requiring a multidimensional evaluation, while the current criteria of follow-up of the RA (DAS28, ACR criteria) investigate the pain in a single dimension that is the pain intensity.

So, the investigators do not arrange explanation for this observed dichotomy between the improvement of the clinical and biological inflammatory criteria of the RA and on the other hand the persistence of pain.

On the other hand, the interleukin (IL)-6, IL-17 and IL-33 are cytokines occurring in the physiopathology of RA and probably in the pain processing according to recent data of the literature.

The aim of this study is:

to assess the multidimensional origin of the pain in RA patients by means of questionnaires
to look for a possible correlation between the serum level of cytokines and pain.

location_facility:
Service de Rhumatologie
CHU Bois-Guillaume
CHU Bordeaux- Pellegrin
CHU Gabriel Montpied
CHU Hôtel-Dieu
CHU Hautepierre
CHU Hôpital R. Salengro


title: Efficacy of Transarterial Chemoembolization With DC-BeadsR Prior to Liver Transplantation for Hepatocellular Carcinoma on Patient Survival : A Prosepctive Multicentre and Randomized Study

acronym: CATCH

summary: The hope to treat more patients with hepatocellular carcinoma successfully is however tempered by the shortage of donors leading to an increasing waiting time for liver transplantation (LT). Intention-to-treat analysis have showed that the reported excellent long-term outcome is curtailed and significantly hampered by the growing incidence of patients who must be removed from the waiting list because of tumor progression. A way to face with this issue is to treat hepatocellular carcinoma prior to LT. Among therapeutic options to impede tumor progression, Transarterial Chemoembolization (TACE) is the most common modality used. While there are many studies concerning TACE in this setting, none are controlled studies and thus there is no firm evidence concerning its efficacy in reducing drop-out or increasing survival. Moreover TACE may induce risks (liver failure, arterial complications…) while waiting for LT. Most of the available data have been based upon analysis of patients who received a transplant and have not included patients who were eligible for LT but died, or showed progression, before it could be performed. Therefore, studies conducted on an intention-to-treat basis are needed to clarify the benefit and the risks of TACE prior to LT in patients with hepatocellular carcinoma.

lead_sponsor: Rennes University Hospital

location_facility: Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris


title: Prospective Study About the Association of Radiotherapy and Cetuximab in the Treatment of Epidermoid Cancers, Locally Advanced, of the Head and Neck.

summary: This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.

status: Unknown status

lead_sponsor: Centre Oscar Lambret

location_facility:
Clinique du Parc
Centre Leonard de Vinci
Centre Bourgogne
Centre Galilée
Centre Joliot Curie
Centre Oscar Lambret
Centre Gray


title: Determinants of the Consultation Delay in Cancers of the Upper Aero Digestive Tract

acronym: DEREDIA

summary: This study aims to determine the impact of sociocognitive and emotional factors on the time of the initial consult

design_allocation: Non-Randomized

primary_purpose: Prevention

ipd_sharing: No

location_facility: Centre Hospitalier Régional et Universitaire - Hopital HURIEZ

intervention_type: Behavioral


title: Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial

acronym: SALPINGOVA

summary: The study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life.

lead_sponsor: University Hospital, Tours

location_facility:
CHU
Hôpital Sud


title: 3% Hypertonic Saline to Reduce Hospitalization Rate in Acute Viral Bronchiolitis: a Randomized Double Blind Clinical Trial

acronym: GUERANDE

summary: The purpose of this study is to determine whether nebulized hypertonic saline solution reduces the admission rate 48 hours after initial treatment in the emergency department, when compared to normal saline solution (control).

ReferenceCitation: Angoulvant F, Bellettre X, Milcent K, Teglas JP, Claudet I, Le Guen CG, de Pontual L, Minodier P, Dubos F, Brouard J, Soussan-Banini V, Degas-Bussiere V, Gatin A, Schweitzer C, Epaud R, Ryckewaert A, Cros P, Marot Y, Flahaut P, Saunier P, Babe P, Patteau G, Delebarre M, Titomanlio L, Vrignaud B, Trieu TV, Tahir A, Regnard D, Micheau P, Charara O, Henry S, Ploin D, Panjo H, Vabret A, Bouyer J, Gajdos V; Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) Study Group. Effect of Nebulized Hypertonic Saline Treatment in Emergency Departments on the Hospitalization Rate for Acute Bronchiolitis: A Randomized Clinical Trial. JAMA Pediatr. 2017 Aug 7;171(8):e171333. doi: 10.1001/jamapediatrics.2017.1333. Epub 2017 Aug 7.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Ecole polytechnique

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CEA - Commissariat à l’énergie atomique

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

publisher_dissemination: American Medical Association

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier intercommunal de Créteil


title: Measurement of the Changes in Acceptability of Hepatitis B Immunization Among General Practitioners and Open-care Paediatricians

acronym: PRALINE

summary: The present study is conducted in order to assess the acceptability of Hepatitis B vaccination in French general practitioners and peadiatricians before and after reimbursement of the paediatric vaccine InfanrixHexa. Two data measurement time points are planned, first before reimbursement and after reimbursement.

time_perspective: Cross-Sectional

lead_sponsor: GlaxoSmithKline


title: Search for Predictors of Therapeutic Response in Patients With Carcinoma of the Ovary, the Fallopian Tube or Peritoneal Serous-type Advanced

acronym: miRSa

summary: In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).

lead_sponsor: Centre Francois Baclesse

location_facility:
Institut de cancerologie de la loire
Centre François BACLESSE
Centre Réné Gauducheau
Centre Eugène Marquis
Centre Oscar LAMBRET
Centre Henri Becquerel
Institut CURIE


title: The Effect of Enzastaurin on CYP2C9: Enzastaurin - S-Warfarin Drug Interaction Study in Patients With Cancer

summary:
The purpose of this study is to assess the effect of enzastaurin (LY317615), on a protein (enzyme CYP2C9) which is involved in the metabolic pathway of warfarin in participants with solid tumors or lymphomas. Information about any side effects that may occur will also be collected. This is a drug interaction study so the treatment of the disease will not be the main purpose of the study.

This is a Phase 1, open label, fixed sequence, 2 period study conducted in participants with solid tumors or lymphomas. The duration of participation in this study will be up to approximately 38 days not including screening, after which participants will be allowed to continue receiving enzastaurin. There is no planned duration for the extension phase of this study; participants will be allowed to continue to receive enzastaurin until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.

primary_purpose: Other

lead_sponsor: Eli Lilly and Company

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


acronym: AFORA

intervention_type: Biological

summary:
Adalimumab is a fully human monoclonal antibody to tumor necrosis factor-alpha (TNF-α) approved in rheumatoid arthritis (RA) refractory to disease modifying anti rheumatic drugs (DMARDs) and for the treatment of severe, active and progressive RA in adults not previously treated with methotrexate.

However, almost one third of patients have no response and approximately 15% develop antibodies towards adalimumab (ATA) after a 6 month course of treatment. There is a relationship between adalimumab concentration and clinical response obtained after 6 month of treatment. Furthermore adalimumab concentration measured 3 months after initiation seems to predict the clinical response at 6 months.

There is an important inter individual pharmacokinetic variability of adalimumab. Side effects may occur at the recommended dose and more than 3 months of treatment are generally required to estimate the clinical response.

A therapeutic drug monitoring could help clinicians to early adjust the dose to optimize the response and to avoid dose related side effects. To date there is no definite adalimumab target concentration predictive of the clinical response to allow such a pharmacologic monitoring.

location_facility:
CHRU de Brest
CHRU de Tours
CHRU de Poitiers
CHR du Mans
CHRU de Nantes
CHRU de Rennes
CHR d'Orléans

title: Serum Concentration of Adalimumab (Humira) as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)


acronym: Ultimate

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

summary:
The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel.

Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage.

Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in association with platinum in first ligne. Different clinical and preclinical data suggest that there could exist a synergy between paclitaxel and bevacizumab. This association is already used in metastatic breast cancer, it permits almost to double the response rate and progression free survival. In lung cancer, the association was evaluated by two retrospective studies which demonstrated a benefit with a favourable safety profile.

ReferenceCitation: Cortot AB, Audigier-Valette C, Molinier O, Le Moulec S, Barlesi F, Zalcman G, Dumont P, Pouessel D, Poulet C, Fontaine-Delaruelle C, Hiret S, Dixmier A, Renault PA, Becht C, Raffy O, Dayen C, Mazieres J, Pichon E, Langlais A, Morin F, Moro-Sibilot D, Besse B. Weekly paclitaxel plus bevacizumab versus docetaxel as second- or third-line treatment in advanced non-squamous non-small-cell lung cancer: Results of the IFCT-1103 ULTIMATE study. Eur J Cancer. 2020 May;131:27-36. doi: 10.1016/j.ejca.2020.02.022. Epub 2020 Apr 8.

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

unpaywall_oa_status: hybrid

location_facility: Lyon - Hôpital Louis Pradel (Pneumologie)

title: Phase III Study Comparing the Efficacy of Paclitaxel-bevacizumab With Docetaxel in 2nd or 3rd Line of Treatment of Non Squamous Non Small Cells Lung Cancer


title: Addition of Suberoylanilide Hydroxamic Acid (Vorinostat) to Azacitidine in Patients With Higher Risk Myelodysplastic Syndromes (MDS): a Phase II add-on Study in Patients With Azacitidine Failure.

acronym: GFM-AZA-VOR

summary:
Azacytidine (AZA) is the current standard of care for frontline patient treated with high-risk MDS and is clinically active in all type of MDS, however, 50% of the patients will never respond. Vorinostat is an orally available HDAC inhibitor with clinical activity in MDS and proven in vitro synergy with AZA. Patient treated upfront with a combination of this agents have shown more responses based on phase I/II data. In the present study, we will use the combination of these two drugs to try to create a synergetic effect and generate a response for patients who experienced treatment failure after AZA.

All eligible patients will be treated with Azacitidine and oral vorinostat for 6 cycles of 28 days. Study Design

lead_sponsor: Groupe Francophone des Myelodysplasies

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Merck Sharp & Dohme LLC

location_facility: Hôpital PURPAN, Service d'Hématologie Clinique

location_facility: Hopital Saint Louis - AP-HP, Hematology Dpt


type: Registry Identifier

title: Cohort Study of Prospective Validation of Predictive Factors and Biological Imaging of Response to Bevacizumab (AVASTIN ®) in Combination With Weekly Paclitaxel Chemotherapy in First Line Treatment Patients With Metastatic Breast Cancer

acronym: COMET

summary:
Bevacizumab plus chemotherapy improves response rates and prolongs PFS when used as first- and second-line therapy for advanced breast cancer. However, bevacizumab has not improved OS in the individual studies currently reported. In Europe, EMA has maintained its indication associated with weekly paclitaxel in first line metastatic breast cancer and more recently with capecitabine based on RIBBON 1 trial's results.

The identification of patient subsets that receive the most clinical benefit would enable more specific treatment administration of bevacizumab and allow patients unlikely to benefit the opportunity to seek other treatment modalities. Unfortunately, despite efforts to identify patient subsets with a differential benefit from bevacizumab, no validated biomarkers have been defined.

The Avastin cohort is a unique opportunity to investigate various biological and imaging parameters which could be related to clinical benefit of the combination of bevacizumab and weekly paclitaxel in first line metastatic breast cancer in a homogeneously treated population in French cancer centers. This trial will gather the expertise of several translational research platforms of different cancer centers from the UNICANCER consortium.

ReferenceType: result

ReferenceCitation: Bortolini Silveira A, Bidard FC, Tanguy ML, Girard E, Tredan O, Dubot C, Jacot W, Goncalves A, Debled M, Levy C, Ferrero JM, Jouannaud C, Rios M, Mouret-Reynier MA, Dalenc F, Hego C, Rampanou A, Albaud B, Baulande S, Berger F, Lemonnier J, Renault S, Desmoulins I, Proudhon C, Pierga JY. Multimodal liquid biopsy for early monitoring and outcome prediction of chemotherapy in metastatic breast cancer. NPJ Breast Cancer. 2021 Sep 9;7(1):115. doi: 10.1038/s41523-021-00319-4.

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

ReferenceCitation: Gal J, Milano G, Brest P, Ebran N, Gilhodes J, Llorca L, Dubot C, Romieu G, Desmoulins I, Brain E, Goncalves A, Ferrero JM, Cottu PH, Debled M, Tredan O, Chamorey E, Merlano MC, Lemonnier J, Etienne-Grimaldi MC, Pierga JY. VEGF-Related Germinal Polymorphisms May Identify a Subgroup of Breast Cancer Patients with Favorable Outcome under Bevacizumab-Based Therapy-A Message from COMET, a French Unicancer Multicentric Study. Pharmaceuticals (Basel). 2020 Nov 23;13(11):414. doi: 10.3390/ph13110414.

publisher_dissemination: MDPI

ReferenceCitation: Vasseur A, Cabel L, Tredan O, Chevrier M, Dubot C, Lorgis V, Jacot W, Goncalves A, Debled M, Levy C, Ferrero JM, Jouannaud C, Luporsi E, Mouret-Reynier MA, Dalenc F, Lemonnier J, Savignoni A, Tanguy ML, Bidard FC, Pierga JY. Prognostic value of CEC count in HER2-negative metastatic breast cancer patients treated with bevacizumab and chemotherapy: a prospective validation study (UCBG COMET). Angiogenesis. 2020 May;23(2):193-202. doi: 10.1007/s10456-019-09697-7. Epub 2019 Nov 26.

ipd_sharing: Yes

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.

lead_sponsor: UNICANCER

location_facility:
CHU Grenoble
Centre Georges Francois Leclerc
Institut Bergonie
Centre Antoine Lacassagne
Institut Jean Godinot
Centre Hospitalier
Institut Claudius Regaud
Centre Catherine de Sienne
Centre Leon Berard
Centre Alexis Vautrin
Institut Curie
Institut Gustave Roussy
Centre Val d'Aurelle
Centre Paul Strauss
Hôpital Européen
Institut Paoli Calmettes
Centre Jean Perrin
Centre Francois Baclesse


lead_sponsor: University Hospital, Lille

summary: The purpose of this study is to determine the efficacy and toxicity profile of Pomalidomide and Dexamethasone in relapsed or refractory Multiple Myeloma patients with deletion 17p or translocation (4;14)

ReferenceCitation: Leleu X, Karlin L, Macro M, Hulin C, Garderet L, Roussel M, Arnulf B, Pegourie B, Kolb B, Stoppa AM, Brechiniac S, Marit G, Thielemans B, Onraed B, Mathiot C, Banos A, Lacotte L, Tiab M, Dib M, Fuzibet JG, Petillon MO, Rodon P, Wetterwald M, Royer B, Legros L, Benboubker L, Decaux O, Escoffre-Barbe M, Caillot D, Fermand JP, Moreau P, Attal M, Avet-Loiseau H, Facon T; Intergroupe Francophone du Myelome (IFM). Pomalidomide plus low-dose dexamethasone in multiple myeloma with deletion 17p and/or translocation (4;14): IFM 2010-02 trial results. Blood. 2015 Feb 26;125(9):1411-7. doi: 10.1182/blood-2014-11-612069. Epub 2015 Jan 9.

publisher_dissemination: American Society of Hematology

sponsor_collaborators:
University Hospital, Lille
Celgene Corporation

location_facility: Centre hospitalier départemental La Roche sur Yon

title: A Multicenter Open Label Phase II Study of Pomalidomide and Dexamethasone in Progressive Relapsed or Refractory Multiple Myeloma Patients With Deletion 17p or Translocation (4;14) Adverse Karyotypic Abnormalities-IFM2010-02


title: Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face

acronym: ImiReduc

summary:
Lentigo malignant (LM) is an intraepidermal melanocytic proliferation occurring on photoexposed skin. In our project, this term applies both to Dubreuilh's melanosis and to Dubreuilh's intraepidermal melanoma. It consequently excludes invasive melanoma. Although surgery is the treatment of choice, it remains without consensus on the margins (5 mm or 10 mm) excision for a localized tumor on the face.

Several studies have shown that imiquimod, activating local immunity by interferon production, induced LM or MLM regression and could also decrease the frequency of relapses.

The principal aim of our project is to study the effect of imiquimod versus placebo in pre-operative neoadjuvant treatment aimed at reducing both surgical margins, as from the first surgical procedure, and the frequency of short and medium term recurrence of LM. Furthermore, the improvement in patient quality of life could also be significant.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
MEDA Pharma GmbH & Co. KG

location_facility: Centre Hospitalier Universitaire de Nantes


title: Randomized Trial to Evaluate the Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers.

summary: The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if <5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.

ReferenceCitation: Bidard FC, Jacot W, Kiavue N, Dureau S, Kadi A, Brain E, Bachelot T, Bourgeois H, Goncalves A, Ladoire S, Naman H, Dalenc F, Gligorov J, Espie M, Emile G, Ferrero JM, Loirat D, Frank S, Cabel L, Dieras V, Cayrefourcq L, Simondi C, Berger F, Alix-Panabieres C, Pierga JY. Efficacy of Circulating Tumor Cell Count-Driven vs Clinician-Driven First-line Therapy Choice in Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: The STIC CTC Randomized Clinical Trial. JAMA Oncol. 2021 Jan 1;7(1):34-41. doi: 10.1001/jamaoncol.2020.5660.

lead_sponsor: Institut Curie

location_facility: Institut régional du Cancer de Montpellier

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


title: Evaluation and Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients Entering Intensive Care Units for Septic Shock

acronym: SEPSICOAG

summary:
A prognostic score was proposed by the investigative team to predict death at 1 month. This score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice management for septic shock.

The main objective of this multicenter study is to validate the performance of the score in terms of area under the ROC curve and negative predictive value.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: CHU de Clermont Ferrand - Hôpital Estaing

location_facility: Centre Hospitalier Universitaire de Nîmes


title: Open-Label Safety Study of a 1-Year 20 mg Dose Regimen of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder (N24HSWD) in Blind Individuals With No Light Perception

summary: The purpose of this study is to evaluate the safety of a one year open-label treatment of tasimelteon in male and female subjects with Non-24-Hour Sleep-Wake Disorder.

enrollment_type: Anticipated

lead_sponsor: Vanda Pharmaceuticals


title: SHOview Observational Study. Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.

acronym: SHOview

summary: Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age treated with HP-hMG.

ReferenceCitation: Barriere P, Dewailly D, Duhamel A, Gayet V. [Ovarian hyperstimulation syndrome after stimulation with highly purified hMGfor in vitro fertilization: Observational study SHOview]. Gynecol Obstet Fertil Senol. 2017 May;45(5):283-290. doi: 10.1016/j.gofs.2017.03.004. Epub 2017 Apr 29. French.

lead_sponsor: Ferring Pharmaceuticals

location_facility: Cabinet Mirabeau Roy René (there may be other sites in this country)

location_facility: Groupe Hospitalier du Havre - Hôpital Jacques Monod

location_facility: Cabinet Médical Lille avenue de Dunkerque


title: Impact of Either Audit and Feedback Only or Audit and Feedback Associated to Cooperative Work Meetings Between Hospital Geriatricians and Nursing Home Staff on Quality Indicators and Health Care Practices in Nursing Homes.

acronym: IQUARE

summary:
Introduction: Efficacy of audit and feedback interventions on nursing home (NH)quality indicators is not well-established.

The main objective: The main purpose of the IQUARE study was to examine the impact of two types of audit and feedback interventions on NH quality indicators and on residents dependence levels in a 18-month follow-up.

Study hypothesis: We hypothesised that audit and feedback associated to educational and professional supportive interventions are more efficacy in improving NH quality indicators than audit and feedback only.

Secondary objectives: Investigate the impact of the interventions on

Residents:

Functional decline rate
Drug prescriptions (quantity and quality)
Prevalence of adverse health outcomes (e.g., falls)

NHs:

Planning and implementation of therapeutic measures

ReferenceCitation: Dubucs X, de Souto Barreto P, Rolland Y. Organizational and environmental factors associated with transfers of nursing home residents to emergency departments. Eur Geriatr Med. 2018 Jun;9(3):339-346. doi: 10.1007/s41999-018-0059-x. Epub 2018 May 8.

ReferenceCitation: Cool C, Cestac P, McCambridge C, Rouch L, de Souto Barreto P, Rolland Y, Lapeyre-Mestre M. Reducing potentially inappropriate drug prescribing in nursing home residents: effectiveness of a geriatric intervention. Br J Clin Pharmacol. 2018 Jul;84(7):1598-1610. doi: 10.1111/bcp.13598. Epub 2018 May 14.

publisher_dissemination: Wiley

ReferenceCitation: Laffon de Mazieres C, Lapeyre-Mestre M, Vellas B, de Souto Barreto P, Rolland Y. Organizational Factors Associated With Inappropriate Neuroleptic Drug Prescribing in Nursing Homes: A Multilevel Approach. J Am Med Dir Assoc. 2015 Jul 1;16(7):590-7. doi: 10.1016/j.jamda.2015.01.092. Epub 2015 Mar 10.

lead_sponsor: Agence Régionale de la Santé - Midi Pyrénées

collaborators: Observatoire Régional de la Santé Midi-Pyrénées (ORSMIP)

location_facility: EHPAD Hermitage et Terrasses de Rabastens

location_facility: Centre hospitalier du Pays d´Olmes - Résidence du Touyre

location_facility: Centre hospitalier du Pays d´Olmes - Laroques d´Olmes

location_facility: EHPAD du Centre Hospitalier Des Deux Rives

location_facility: EHPAD Villégiale Saint Jacques CHIC - CASTRES/MAZAMET

location_facility: EHPAD Résidence Mutualiste La Pyrénéenne


title: Impact on Mortality of the Timing of Renal Replacement Therapy in Patients With Severe Acute Kidney Injury in Septic Shock: the IDEAL-ICU Study (Initiation of Dialysis Early Versus Delayed in the Intensive Care Unit): Study Protocol for a Randomized Controlled Trial

acronym: IDEAL-ICU

summary: The purpose of this multicentric, randomized controlled trial is to assess whether the timing of renal replacement therapy initiation (early vs delayed) has an impact on mortality at 90 days in patients with severe acute kidney injury at the failure stage (according to RIFLE criteria) during the initial phase of septic shock.

ReferenceCitation: Barbar SD, Binquet C, Monchi M, Bruyere R, Quenot JP. Impact on mortality of the timing of renal replacement therapy in patients with severe acute kidney injury in septic shock: the IDEAL-ICU study (initiation of dialysis early versus delayed in the intensive care unit): study protocol for a randomized controlled trial. Trials. 2014 Jul 7;15:270. doi: 10.1186/1745-6215-15-270.

ReferenceCitation: Barbar SD, Clere-Jehl R, Bourredjem A, Hernu R, Montini F, Bruyere R, Lebert C, Bohe J, Badie J, Eraldi JP, Rigaud JP, Levy B, Siami S, Louis G, Bouadma L, Constantin JM, Mercier E, Klouche K, du Cheyron D, Piton G, Annane D, Jaber S, van der Linden T, Blasco G, Mira JP, Schwebel C, Chimot L, Guiot P, Nay MA, Meziani F, Helms J, Roger C, Louart B, Trusson R, Dargent A, Binquet C, Quenot JP; IDEAL-ICU Trial Investigators and the CRICS TRIGGERSEP Network. Timing of Renal-Replacement Therapy in Patients with Acute Kidney Injury and Sepsis. N Engl J Med. 2018 Oct 11;379(15):1431-1442. doi: 10.1056/NEJMoa1803213.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ParisTech

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: CHU de Strasbourg - Nouvel hôpital civil

location_facility: Groupe Hospitalier de l'institut Catholique de LILLE

location_facility: Hôpital Raymond-Poincaré GARCHES (AP-HP)


title: Everolimus as Treatment After Embolization or Chemoembolization for Liver Metastases From Digestive Endocrine Tumors

acronym: EVACEL

summary:
Determine wether 24 months treatment with everolimus prolongs progression free survival rate (based on a central assessment) after embolisation ou chemoembolisation for liver metastases.

H0 a 24 months progression free survival rate less than 35% is unacceptable
H1 a 24 months progression free survival rate greater than 35% would show that everolimus treatment is beneficial, the expected 24 months progression free survival rate being 50%

ReferenceCitation: Walter T, Lepage C, Coriat R, Barbier E, Cadiot G, Caroli-Bosc FX, Aparicio T, Bouhier-Leporrier K, Hentic-Dhome O, Gay F, Dupont-Gossart AC, Duluc M, Lepere C, Lecomte T, Smith D, Petorin C, Di-Fiore F, Ghiringhelli F, Legoux JL, Guimbaud R, Baudin E, Lombard-Bohas C, de Baere T; FFCD 1104 investigators/investigators. Everolimus after hepatic arterial embolisation therapy of metastases from gastrointestinal neuroendocrine tumours: The FFCD 1104-EVACEL-GTE phase II study. Eur J Cancer. 2019 Dec;123:92-100. doi: 10.1016/j.ejca.2019.09.021. Epub 2019 Oct 31.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Hôpital Avicenne
Hôpital Européen Georges Pompidou
Hôpital Rangueil
CHU Cochin
CHU - Estaing
Hôpital Côte de Nacre
Centre GF Leclerc
CHU
CHU - Hôpital François Mitterand
CHU - Hôtel Dieu
Hôpital Saint André
CHU La Timone
Hôpital Edouard Herriot
Hôpital Trousseau
Hôpital Beaujon
CHR
Institut Gustave Roussy
Hôpital Robert Debré


title: Phase II: First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis

summary:
The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer, with an objective response rate of about 70 %. This phase II is to investigate if this systematic attack chemotherapy could control at the same time the rectal tumor and the synchronous metastasis without compromising secondarily the tumor or the metastasis resection or a radiochemotherapy administration.

The main objective of the trial is to investigate the tumoral control rate at 4 months, according to the RECIST criteria (version 1.1).

The secondary objectives are:

safety of the treament,
rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation),
survival without local failure (radiological or clinical progression of the rectal cancer or local complication),
rectal tumor response rate (CT scan, MRI and endocopy),
metastasis response rate,
disease free survival after complete resection (of primitive tumor and metastases),
progression free survival (local or distal),
overall survival, quality of life (QLQ-C30 + CR 29).

ReferenceCitation: Bachet JB, Lucidarme O, Levache CB, Barbier E, Raoul JL, Lecomte T, Desauw C, Brocard F, Pernot S, Breysacher G, Lagasse JP, Di Fiore F, Etienne PL, Dupuis OJM, Aleba A, Lepage C, Taieb J; for FFCD 1102 investigators. FOLFIRINOX as induction treatment in rectal cancer patients with synchronous metastases: Results of the FFCD 1102 phase II trial. Eur J Cancer. 2018 Nov;104:108-116. doi: 10.1016/j.ejca.2018.09.006. Epub 2018 Oct 18.

sponsor_collaborators: Federation Francophone de Cancerologie Digestive

location_facility:
Avicennes
CHU - Ht Lévêque
Centre G.F. Leclerc
CHRU - Hôpital Huriez
CHRU Trousseau
CHR - Gasto
CH Robert Morlevat
Centre Cahterine de Sienne
CH Layne
Ipc - Cac
AP - HP - Pitié Salpêtrière
CHU La Timone
Polyclinique Côte Basque Sud
Clinique Saint Jean du Languedoc
CH
Colmar Ch
Polyclinique
Clinique Victor Hugo
CAC
CH Le Foll
Clinique Armoricaine
Institut Bergonie
CHU
Polyclinique le Languedoc
Polyclinique de l'Ormeau
CHD Vendée
Hôpitaux du Leman
CH Georges Menon
CHU d'Estaing


title: Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

summary: This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU) characteristics known as possible prognostic markers, and which sociodemographic and psychologic factors associated with VLU are associated with complete healing at 24 weeks.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

collaborators: Institut de Recherches Internationales Servier

location_facility: Centre Hospitalo-Universitaire d'Amiens - Dermatologie

location_facility: Hôpital Claude Huriez - Clinique Dermatologique

location_facility: Hôpital Rothschild - Consultation de Dermatologie

location_facility: Hôpital d'Instruction des Armées Desgenettes

location_facility: Centre Hospitalier de Valence - Dermatologie

location_facility: Cabinet de Dermatologie 43, rue Jean Lecanuet

location_facility: Cabinet de Dermatologie 1,rue dembarrère

location_facility: Centre Hospitalier Intercommunal Poissy Saint Germain

location_facility: Hôpitaux Civils de Colmar - Service de Dermatologie

location_facility: Centre Hospitalier - Service de Médecine Interne

location_facility: Hôpital Sainte Marguerite - Dermatologie

location_facility: Hôpital Broussais - Rééducation Vasculaire

location_facility: Hôpital C. Foix - Service de Gérontologie

location_facility: Hôpital Saint Vincent de Paul - Médecine interne et Gériatrie I

location_facility: Hôpital Saint Louis - Service de Dermatologie

location_facility: Centre Hospitalier Laennec - Dermatologie

location_facility: Hôpital Charles NICOLLE - Service de Dermatologie


title: A Prospective Cohort Study Assessing the Efficacy and Safety of Tarceva in 2nd Line in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

summary: This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients will be followed for 12 months.

lead_sponsor: Hoffmann-La Roche


title: Evaluation of the VQ11 Auto-questionnaire of Quality of Life in Pneumology Investigation, During the Implementation of a Long-acting Bronchodilator Treatment of Patients With COPD.

acronym: EPIC

summary:
The purpose of this study is to estimate the capacity of the auto-questionnaire of quality of life, VQ11, to follow the evolution of patients with COPD (Chronic obstructive pulmonary disease) in stable state (without exacerbation in the previous 6 weeks) (3 months +/-15 days) during the implementation of a LABD (Long-acting bronchodilator) treatment.

The main objective is to compare the total Score of the VQ11 auto-questionnaire before and after LABD. A decrease of 5 points of the total score mimicking an improvement in the quality of life linked to health, specifically in the COPD.

primary_purpose: Screening

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens

location_facility:
Centre Médical
Hopital Jacques MONOD
Hopital Maison Blanche
Zac Gouraud
Résidence Saint Michel
Centre hospitalier de St Quentin
CH Creil
CHRU de Lille
CH de DOUAI
CHU de Rouen
Clinique de l'Europe
CHU Amiens Sud
CHU Amiens Nord
Centre Hospitalier de Compiègne
Centre Hospitalier de Chauny


title: Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA Administered in Combination With Peg-IFN and Ribavirin in Chronic HCV-infected Patients for 4 Weeks, a Randomised, Double-blind, Placebo Controlled Study

summary: The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.

ReferenceCitation: Larrey D, Lohse AW, de Ledinghen V, Trepo C, Gerlach T, Zarski JP, Tran A, Mathurin P, Thimme R, Arasteh K, Trautwein C, Cerny A, Dikopoulos N, Schuchmann M, Heim MH, Gerken G, Stern JO, Wu K, Abdallah N, Girlich B, Scherer J, Berger F, Marquis M, Kukolj G, Bocher W, Steffgen J. Rapid and strong antiviral activity of the non-nucleosidic NS5B polymerase inhibitor BI 207127 in combination with peginterferon alfa 2a and ribavirin. J Hepatol. 2012 Jul;57(1):39-46. doi: 10.1016/j.jhep.2012.02.015. Epub 2012 Mar 10.

lead_sponsor: Boehringer Ingelheim

location_country: Germany Switzerland France

location_facility: 1241.7.49010 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49009 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49013 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49002 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.41004 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.41003 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.41001 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49011 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49012 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49001 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49004 Boehringer Ingelheim Investigational Site


title: A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

summary: This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).

lead_sponsor: Millennium Pharmaceuticals, Inc.

collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country: Germany Italy France Switzerland Spain Greece Israel

location_facility: Rabin Medical Center - Hematology Institute

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine

location_facility: Haemek Medical Center - Hematology Department

location_facility: Hospital Puerta del Mar, Secretaría de Hematología, 1ª planta

location_facility: Kantonsspital St.Gallen Department of Oncology/Hematology

location_facility: Universitatsklinikum Gottingen, zentrum Innere medicin

location_facility: Divisione di Ematologia Ospedale San Bortolo - Hematology

location_facility: University Hospital of Heraklion- Department of Hematology

location_facility: Università La Sapienza, Dipartimento di Biotecnologie Cellulari ed Ematologia, Via Benevento, 6

location_facility: Rambam Med.Center - Hematology Institute

location_facility: Clinica di Ematologia DIMI - A.O. Ospedale S. Martino

location_facility: Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta

location_facility: Istituto Di Ematologia E Oncologia Medica - L.A. Seragnoli - Policlinico S.Orsola Malpighi

location_facility: Hadassah University Hospital - Hematology Department

location_facility: Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta

location_facility: Klinikum der Stadt Villinger-Schwenningen


title: Randomized Phase III Trial Comparing Induction Chemotherapy Followed by Radiotherapy to Concomitant Chemoradiotherapy for Laryngeal Preservation in T3MO Pyriform Sinus Carcinoma

summary:
Patients were eligible if they had biopsy proven, previously untreated T3 with fixed cord involvement squamous cell carcinoma of the pyriform sinus.

The study compare conventional radiotherapy with concurrent cisplatin to induction chemotherapy with cisplatin fluorouracil followed by conventional radiotherapy. The primary end point was the preservation of the larynx. The secondary end points included toxicity, causes of death and survival rates.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: PIGNAT LACHEB LITAS CALLOC'H MAYAUD Lallemant Crampette


title: Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab

acronym: TSARINE

summary: Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.

lead_sponsor: Centre Oscar Lambret

location_facility:
Oncorad Garonne
Centre médical Oncogard
Centre René Huguenin
Clinique Clinique Clementville
Centre Médical de Forcilles
Centre Hospitalier de Mulhouse
Clinique des Ormeaux- Vauban
Hôpital Tenon
Centre de Cancérologie Paris Nord
Centre Bourgogne
Centre Hospitalier
Centre Léonard de Vinci
Institut Gustave Roussy
Centre Oscar LAMBRET
Centre Alexis Vautrin
CHU Dupuytren
Centre G-François Baclesse
Centre Antoine Lacassagne
Centre Hospitalier LYON SUD
Centre Paul Papin
Centre Azuréen de Cancérologie
Clinique Hartmann
Centre Maurice Tubiana
Centre Catherine de Sienne
Centre Catalan d'Oncologie
Centre Etienne DOLET


title: Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120

summary:
The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters.

Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.

location_facility: 1199.16.3302A Boehringer Ingelheim Investigational Site

location_facility: 1199.16.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.16.3313A Boehringer Ingelheim Investigational Site

location_facility: 1199.16.49008 Boehringer Ingelheim Investigational Site

location_facility: 1199.16.3311A Boehringer Ingelheim Investigational Site

location_facility: 1199.16.3311B Boehringer Ingelheim Investigational Site

location_facility: 1199.16.3306A Boehringer Ingelheim Investigational Site

location_facility: 1199.16.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.16.3313E Boehringer Ingelheim Investigational Site

location_facility: 1199.16.3312A Boehringer Ingelheim Investigational Site

location_facility: 1199.16.49005 Boehringer Ingelheim Investigational Site


title: A 24-Week Multicentre, Randomized, Double-Blind, Controlled, Parallel Group Non-Inferiority Study to Assess the Efficacy and Safety of Olmesartan Medoxomil Versus Candesartan Cilexetil in Patients With Symptomatic Heart Failure (NYHA II-IV)

acronym: OLMEBNP

summary: This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

location_country: Germany Netherlands France


title: Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency

acronym: Hypolyte

summary: Interest of treatment of polytraumatisms with corticoids (hydrocortisone) for patient with relative adrenocortical insufficiency on frequency of nosocomial infection, and hemodynamic complications and organs injuries.

ReferenceCitation: Le Bras M, Roquilly A, Deckert V, Langhi C, Feuillet F, Sebille V, Mahe PJ, Bach K, Masson D, Lagrost L, Costet P, Asehnoune K, Cariou B. Plasma PCSK9 is a late biomarker of severity in patients with severe trauma injury. J Clin Endocrinol Metab. 2013 Apr;98(4):E732-6. doi: 10.1210/jc.2012-4236. Epub 2013 Feb 28.

publisher_dissemination: The Endocrine Society

ReferenceCitation: Asehnoune K, Mahe PJ, Seguin P, Jaber S, Jung B, Guitton C, Chatel-Josse N, Subileau A, Tellier AC, Masson F, Renard B, Malledant Y, Lejus C, Volteau C, Sebille V, Roquilly A. Etomidate increases susceptibility to pneumonia in trauma patients. Intensive Care Med. 2012 Oct;38(10):1673-82. doi: 10.1007/s00134-012-2619-8. Epub 2012 Jul 10.

ReferenceCitation: Roquilly A, Mahe PJ, Seguin P, Guitton C, Floch H, Tellier AC, Merson L, Renard B, Malledant Y, Flet L, Sebille V, Volteau C, Masson D, Nguyen JM, Lejus C, Asehnoune K. Hydrocortisone therapy for patients with multiple trauma: the randomized controlled HYPOLYTE study. JAMA. 2011 Mar 23;305(12):1201-9. doi: 10.1001/jama.2011.360.

sponsor_collaborators:
Nantes University Hospital
Serb

location_facility:
CHU Morvan de Brest
CHU Pontchaillou
CHU Bordeaux
CH La Roche Sur Yon
CHU Caen
Hôtel Dieu
CHU Trousseau


acronym: CHIVA

lead_sponsor: ARCAGY/ GINECO GROUP

summary:
Patients with extensive and bulky disease are often those whose initial surgery is delayed after 3 or 4 cycles of neo-adjuvant chemotherapy.

In that case, there is, indeed, some concern to administer bevacizumab during the chemotherapy surrounding the interval debulking surgery due to the long half life (14- 21 days) of this monoclonal antibody and the interference of anti angiogenic agents with wound healing.

Vargatef® (Nintedanib) might offer a better alternative to bevacizumab in the neo-adjuvant setting. Vargatef® (Nintedanib) has a much shorter half-life of 7 to 19 hours. Preliminary experience in cancer did not show a trend for increased incidence of fistula or bowel perforation. For more details please refer to the investigator drug brochure for Vargatef® (Nintedanib).

This trial will compare progression-free survival and surgical complications of 188 patients with FIGO stage IIIC/IV treated in first line with either neo-adjuvant chemotherapy (carboplatin & paclitaxel) and interval debulking surgery or the same treatment + Vargatef® (Nintedanib).

ReferenceCitation: Aide N, Fauchille P, Coquan E, Ferron G, Combe P, Meunier J, Alexandre J, Berton D, Leary A, De Rauglaudre G, Bonichon N, Pujade Lauraine E, Joly F. Predicting tumor response and outcome of second-look surgery with 18F-FDG PET/CT: insights from the GINECO CHIVA phase II trial of neoadjuvant chemotherapy plus nintedanib in stage IIIc-IV FIGO ovarian cancer. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1998-2008. doi: 10.1007/s00259-020-05092-3. Epub 2020 Nov 21.

oa_colors: green hybrid

evidence: open (via crossref license)

ReferenceCitation: Robelin P, Tod M, Colomban O, Lachuer J, Ray-Coquard I, Rauglaudre G, Joly F, Chevalier-Place A, Combe P, Lortholary A, Hamizi S, Raban N, Ferron G, Meunier J, Berton-Rigaud D, Alexandre J, Kaminsky MC, Dubot C, Leary A, Malaurie E, You B. Comparative analysis of predictive values of the kinetics of 11 circulating miRNAs and of CA125 in ovarian cancer during first line treatment (a GINECO study). Gynecol Oncol. 2020 Oct;159(1):256-263. doi: 10.1016/j.ygyno.2020.07.021. Epub 2020 Jul 22.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Huriez

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Milétrie - Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Hospitalier Universitaire Dupuytren

title: Randomized Double Blind Placebo-controlled Phase II Trial of Vargatef® (Nintedanib) in Addition to First Line Chemotherapy With Interval Debulking Surgery in Patients With Adenocarcinoma of the Ovary, the Fallopian Tube or Serous Adenocarcinoma of the Peritoneum


title: Phase I-II Clinical and Pharmacokinetic Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) and to investigate the efficacy, safety and pharmacokinetics of irofulven combined with oxaliplatin in patients with advanced solid tumors.

lead_sponsor: Eisai Inc.


title: A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients

summary: A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer

lead_sponsor: Eli Lilly and Company

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Safety of Nivestim® in Patients Treated With Neutropenia-inducing Anticancer Chemotherapy in Routine Practice

summary: The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.

ReferenceCitation: Kamioner D, Fruehauf S, Maloisel F, Cals L, Lepretre S, Berthou C. Study design: two long-term observational studies of the biosimilar filgrastim Nivestim (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia. BMC Cancer. 2013 Nov 16;13:547. doi: 10.1186/1471-2407-13-547.

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

lead_sponsor: Hospira, now a wholly owned subsidiary of Pfizer

location_facility:
CHG William MOREY
CH de Draguignan
Pole Sante Republique
Clinique Belvédère
Hopital St Quentin
Clinique Beausoleil
Polyclinique Cesson
Clinique Porte St Cloud
CHG Dieppe
Hopital Troyes
Ch St Malo
H.I.A Saint Anne
BEAUJON
Clinique Pasteur
Inst. Claudius Regaud
Chu St Eloi
Clinique Vitalia Desertines
Chu Estaing
CHU SUD
Hopital Franco Britannique
Ch Valence
Hopital Foch
CHG Cahors
CHI de Fréjus
Clinique CONVERT
Ch Cholet
Chu Rennes
Chu Hopital Civil
Clinique Ste Marie
Chi Frejus - St Raphael
Chp St Greg
Chu Gabriel Montpied
Clinique des Dentellieres
Hopital Jean Monnet
Saint Louis
Ch Duffaut
Clinique du Cap d'Or
CH Emile Muller
Ch Chambery
CHG
Clinique Rambot
CHG St Gaudens
CHRA
TENON
IPC
CH Boulogne-sur-Mer
Ch Le Mans
CAC Paul Strauss
Centre Oscar Lambret
CHU Caremeau
Clinique Ste Marguerite
Saint Antoine
Hpt Rene Dubos
CHU du BOCAGE
Ch Du Pays D'Aix
CHU Purpan
Chu Grenoble
Icl St Etienne
Chg St Jean
STE ANNE
CHR
Clinique St Faron
Hopital Louis Pasteur
MEDIPOLE
Clinique de l'Ormeau
Hopital Mignot
Fondation Saint Joseph
Hopital Des Courses
HARTMANN
Chr Brive
Ico Angers
CHICAS
Hopital A.Pare
Centre frederic joliot curie
Cac Jean Godinot
Chu Timone
Chp Clairval
Victor Hugo
Clinique St Laurent
CH Sainte Musse
CH Jacques Monod
Victor Dubos
Centre Rene Huguenin
Clinique des Bonnettes


title: Randomized Cross Over Double Blind Versus Placebo Trial Followed by an Open Phase Studying Effect of Norditropin® on Left Ventricular Mass of Growth Hormone Deficient Adult Patients

summary: This trial is conducted in Europe. The aim of this trial is to assess the effect of somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients with a growth hormone deficiency.

lead_sponsor: Novo Nordisk A/S


title: French Randomized Sentinel Node Multicentric Study

summary:
RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.

primary_purpose: Diagnostic

ReferenceCitation: Rodier JF, Velten M, Wilt M, Martel P, Ferron G, Vaini-Elies V, Mignotte H, Bremond A, Classe JM, Dravet F, Routiot T, de Lara CT, Avril A, Lorimier G, Fondrinier E, Houvenaeghel G, Avigdor S. Prospective multicentric randomized study comparing periareolar and peritumoral injection of radiotracer and blue dye for the detection of sentinel lymph node in breast sparing procedures: FRANSENODE trial. J Clin Oncol. 2007 Aug 20;25(24):3664-9. doi: 10.1200/JCO.2006.08.4228. Epub 2007 May 7.

lead_sponsor: Centre Paul Strauss

location_facility:
Institut J. Paoli and I. Calmettes
Clinique Tivoli
Institut Claudius Regaud
Centre Regional Rene Gauducheau
Centre Leon Berard
Centre Paul Strauss
Centre Jean Perrin


title: Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

acronym: GOOSE

summary:
The aim of this observational study is to compare the outcomes of three different procedures performed for the management of malignant Gastric Outlet Obstruction due to Pancreatic Cancer.

Patients who undergo:

Surgical gastroenterostomy
Endoscopic placement of a self-expanding metallic stent
EUS-guided gastroenterostomy in accordance with standard clinical practice, will be enrolled to evaluate potential differences between the procedures in terms of clinical success, eating experience, chemotherapy tolerance, and nutritional status during follow-up.

Participants will be asked to complete a quality of life questionnaire at baseline and during follow-up; however, no additional procedures will be conducted as a result of participation in the study.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Jeurnink SM, Steyerberg EW, van Hooft JE, van Eijck CH, Schwartz MP, Vleggaar FP, Kuipers EJ, Siersema PD; Dutch SUSTENT Study Group. Surgical gastrojejunostomy or endoscopic stent placement for the palliation of malignant gastric outlet obstruction (SUSTENT study): a multicenter randomized trial. Gastrointest Endosc. 2010 Mar;71(3):490-9. doi: 10.1016/j.gie.2009.09.042. Epub 2009 Dec 8.

ReferenceCitation: van Wanrooij RLJ, Vanella G, Bronswijk M, de Gooyer P, Laleman W, van Malenstein H, Mandarino FV, Dell'Anna G, Fockens P, Arcidiacono PG, van der Merwe SW, Voermans RP. Endoscopic ultrasound-guided gastroenterostomy versus duodenal stenting for malignant gastric outlet obstruction: an international, multicenter, propensity score-matched comparison. Endoscopy. 2022 Nov;54(11):1023-1031. doi: 10.1055/a-1782-7568. Epub 2022 Mar 24.

ReferenceCitation: Bronswijk M, Vanella G, van Malenstein H, Laleman W, Jaekers J, Topal B, Daams F, Besselink MG, Arcidiacono PG, Voermans RP, Fockens P, Larghi A, van Wanrooij RLJ, Van der Merwe SW. Laparoscopic versus EUS-guided gastroenterostomy for gastric outlet obstruction: an international multicenter propensity score-matched comparison (with video). Gastrointest Endosc. 2021 Sep;94(3):526-536.e2. doi: 10.1016/j.gie.2021.04.006. Epub 2021 Apr 20.

ReferenceCitation: Boghossian MB, Funari MP, De Moura DTH, McCarty TR, Sagae VMT, Chen YI, Mendieta PJO, Neto FLP, Bernardo WM, Dos Santos MEL, Chaves FT, Khashab MA, de Moura EGH. EUS-guided gastroenterostomy versus duodenal stent placement and surgical gastrojejunostomy for the palliation of malignant gastric outlet obstruction: a systematic review and meta-analysis. Langenbecks Arch Surg. 2021 Sep;406(6):1803-1817. doi: 10.1007/s00423-021-02215-8. Epub 2021 Jun 14.

lead_sponsor: IRCCS San Raffaele

collaborators: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

location_country: Turkey Italy Portugal France

location_facility:
Hôpital la pitié salpêtrière, APHP
IRCCS San Raffaele Scientific Institute
ISMETT - University of Palermo
Acibadem Maslak Hospital
São João University Hospital