title: A Phase I/II Multicenter Trial Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and the Anti-Programmed Death-ligand 1 (PD-L1) Durvalumab (Medi4736) for Patients With Recurrent Glioblastoma (STERIMGLI)

acronym: STERIMGLI

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

The phase I part of the study aims to evaluate the safety of the association of hypofractionated stereotactic radiation therapy (hFSRT) and the anti-PD-L1 Durvalumab immunotherapy in patients with recurrent glioblastoma. A maximum number of 12 patients will be enrolled in this phase I part.

Once the recommended combination schema will be declared, patients will be enrolled in the Phase II part of the study in order to evaluate the efficacy (overall survival) of the combined treatment in recurrent glioblastoma. In this Phase II part, 100 patients will be assigned by randomization to one of the two following arms:

Arm A (control arm): Radiation therapy alone
Arm B (Experimental arm): Combined treatment with Anti-PD-L1 Durvalumab

lead_sponsor: Institut Claudius Regaud

sponsor_collaborators:
Institut Claudius Regaud
AstraZeneca

location_facility: Institut Regional Du Cancer de Montpellier


title: Abdominal Compartment Syndrome and Ruptured Aortic Aneurysm : Validation of a Predictive Test

acronym: SCA-AAR

summary:
It is an observational study on ruptured abdominal aortic aneurysm and abdominal compartment syndrome.

the aim of this study is to assess the qualities of a predictive score on the occurence of this syndrome after surgery of ruptured aortic aneurysm

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Leclerc B, Salomon Du Mont L, Parmentier AL, Besch G, Rinckenbach S. Abdominal compartment syndrome and ruptured aortic aneurysm: Validation of a predictive test (SCA-AAR). Medicine (Baltimore). 2018 Jun;97(25):e11066. doi: 10.1097/MD.0000000000011066.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU Strasbourg
CHU
CH

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown

appel_a_projets: PHRCI

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

type_etablissement: CH

acronyme: SCAAR

titre: Syndrome du Compartiment Abdominal et Anévrismes de l'Aorte Rompus : validation d'un test prédictif

discipline_principale: autre

nom_porteur: RINCKENBACH

prenom_porteur: Simon


type: Other Identifier

title: APPLE Trial: Feasibility and Activity of AZD9291 (Osimertinib) Treatment on Positive PLasma T790M in EGFR Mutant NSCLC Patients

acronym: APPLE

summary: The phase II APPLE trial gives the opportunity to prospectively validate liquid biopsies as a new standard for testing tumor progression compared with conventional radiological procedure in EGFR mutant advanced NSCLC patients. Moreover based on the sequential T790M test during treatment the investigators will assess the predictive value of liquid biopsies. APPLE trial will examine the best strategy for delivering osimertinib (upfront versus sequential treatment after 1st generation EGFR TKI) in EGFR mutant NSCLC patients. Finally, the trial will also explore the mechanisms of acquired resistance to Osimertinib based on the results of an optional biopsy upon progression.

study_start_date_type: Actual

status: Active, not recruiting

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Slovenia Poland Spain Jordan France

location_facility: University Hospital A Coruna-Hospital Teresa Herrera

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital De Mataro

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Centre Hopitalier Intercommunal De Creteil

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Health Economic Analysis of Islet Cell Transplantation for Patients With Severe Forms of Brittle Type 1 Diabetes

acronym: STABILOT

summary: The main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as Sensor augmented pump therapy) for patients with brittle type1 diabetes.

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Barton FB, Rickels MR, Alejandro R, Hering BJ, Wease S, Naziruddin B, Oberholzer J, Odorico JS, Garfinkel MR, Levy M, Pattou F, Berney T, Secchi A, Messinger S, Senior PA, Maffi P, Posselt A, Stock PG, Kaufman DB, Luo X, Kandeel F, Cagliero E, Turgeon NA, Witkowski P, Naji A, O'Connell PJ, Greenbaum C, Kudva YC, Brayman KL, Aull MJ, Larsen C, Kay TW, Fernandez LA, Vantyghem MC, Bellin M, Shapiro AM. Improvement in outcomes of clinical islet transplantation: 1999-2010. Diabetes Care. 2012 Jul;35(7):1436-45. doi: 10.2337/dc12-0063.

ReferenceCitation: Beckwith J, Nyman JA, Flanagan B, Schrover R, Schuurman HJ. A health economic analysis of clinical islet transplantation. Clin Transplant. 2012 Jan-Feb;26(1):23-33. doi: 10.1111/j.1399-0012.2011.01411.x. Epub 2011 Feb 16.

ReferenceCitation: Bellin MD, Kandaswamy R, Parkey J, Zhang HJ, Liu B, Ihm SH, Ansite JD, Witson J, Bansal-Pakala P, Balamurugan AN, Papas KK, Sutherland DE, Moran A, Hering BJ. Prolonged insulin independence after islet allotransplants in recipients with type 1 diabetes. Am J Transplant. 2008 Nov;8(11):2463-70. doi: 10.1111/j.1600-6143.2008.02404.x. Epub 2008 Sep 19. Erratum In: Am J Transplant. 2010 May;10(5):1337. Papas, K [corrected to Papas, K K].

ReferenceCitation: Badet L, Benhamou PY, Wojtusciszyn A, Baertschiger R, Milliat-Guittard L, Kessler L, Penfornis A, Thivolet C, Renard E, Bosco D, Morel P, Morelon E, Bayle F, Colin C, Berney T; GRAGIL Group. Expectations and strategies regarding islet transplantation: metabolic data from the GRAGIL 2 trial. Transplantation. 2007 Jul 15;84(1):89-96. doi: 10.1097/01.tp.0000268511.64428.d8.

ReferenceCitation: Lablanche S, David-Tchouda S, Margier J, Schir E, Wojtusciszyn A, Borot S, Kessler L, Morelon E, Thivolet C, Pattou F, Vantyghem MC, Berney T, Benhamou PY. Randomised, prospective, medico-economic nationwide French study of islet transplantation in patients with severely unstable type 1 diabetes: the STABILOT study protocol. BMJ Open. 2017 Feb 20;7(2):e013434. doi: 10.1136/bmjopen-2016-013434.

publisher_dissemination: British Medical Journal

lead_sponsor: University Hospital, Grenoble

location_country: Switzerland France

location_facility:
University Hospital of Montpellier
university hospital of Nantes
University Hospital of Besançon
University Hospital of Geneva
APHP
Grenoble University Hospital
university hospital of Clermont Ferrand
University Hospital of Lyon
University hospital of Strasbourg
University hospital of Lille
University hospital of Nancy

appel_a_projets: PRME

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

acronyme: STABILOT

titre: Impact médico-économique de la stabilisation des formes sévères de diabète de type 1 par transplantation d'îlots pancréatiques

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: Benhamou

prenom_porteur: Pierre Yves


title: Cost Utility of Radical Surgery in Ovarian Cancer

acronym: CURSOC

summary: The purpose of this study is to investigate the medico-economic impact of adherence to INCa (National Cancer Institute) guidelines in ovarian cancer surgery by assessment of outcome in cost per Quality Adjusted Life Years (QALY).

primary_purpose: Health Services Research

ReferenceCitation: Filleron T, Lusque A, Dalenc F, Ferron G, Roche H, Martinez A, Jouve E. Alternative methodological approach to randomized trial for surgical procedures routinely used. Contemp Clin Trials. 2018 May;68:109-115. doi: 10.1016/j.cct.2018.03.016. Epub 2018 Mar 30.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

location_facility: Hopital Nord-Ouest - Villefranche Sur Saone

intervention_type: Other

appel_a_projets: PRMEK

region: Occitanie

nom_etablissement: INSTITUT CLAUDIUS REGAUD ONCOPOLE

type_etablissement: CLCC

acronyme: CURSOC 01

titre: Coût utilité de la chirurgie radicale dans les cancers de l´ovaire

discipline_principale: ovarian cancer, peritoneal primary cancer

nom_porteur: MARTINEZ

prenom_porteur: Alejandra


title: Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis

acronym: MODIMUCOR

summary:
This Study evaluates the performance (sensitivity, specificity, positive and negative predictive value values and likelihood ratios) of the DNA detection test for the diagnosis of mucormycosis by comparing it to the routine tests such as CT scan aspects, histopathology, microscopy and fungal culture, in a test group of 52 patients including :

patients at high-risk according to the EORTC/MSG criteria (patients with prolonged severe neutropenia, receiving corticosteroids or T-cell suppressors, recipients of allogeneic HSCT, or inherited severe immunodeficiency),
patients with other predisposing factors of invasive mould disease ( diabetes, AIDS, haematological malignancies or solid tumours, trauma, burns); Patients already diagnosed with probable or proven mucormycosis irrespective of underlying conditions.

status: Completed

study_completion_date_type: Actual

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Régional Universitaire

status_simplified: Completed

appel_a_projets: PHRCN

acronyme: MODI MUCOR

titre: Evaluation prospective d'un nouvel outil moléculaire pour le diagnostic précoce des mucormycoses

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: MILLON

prenom_porteur: Laurence


title: Evidence of Abnormal Fecal Microbiota in Healthy Subjects at High Risk for Crohn's Disease: Family Studies and Relations With a Particular Genetic Profile and Serological. Comparison of Affected Individuals, Their Siblings and Healthy Controls.

acronym: MAGIC

summary: Transversal multicentric French study on the microbiota in patients with Crohn's disease and their first degree healthy relatives The primary objective is the comparison of microbiota between patients with CD, healthy controls non genetically linked and first degree healthy relatives of patients with CD.

time_perspective: Cross-Sectional

ipd_sharing: Undecided

lead_sponsor: University Hospital, Lille

location_facility:
Aphp Necker
APHP Kremlin Bicêtre
Nancy University Hospital
Aphp St Antoine
Amiens University & Hospital
cLERMONT fERRAND University Hospital
Rouen University Hospital
Hôpital Claude Huriez, CHRU
APHP Robert Debré
CHRU,Hôpital Jeanne de Flandres


title: Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions

acronym: LIPA-DRAIN

summary:
Surgery is the principal treatment for benign and malignant pancreatic tumours. This surgery can be accompanied by complications among which the main one is pancreatic fistula, which leads to the flow of pancreatic juices into the abdominal cavity. Depending on its severity, a fistula can be managed medically, with the implantation of a la pose d'un percutaneous drain, endoscopic treatment, or revisit surgery. It has been shown that early management of the fistula prevents it from evolving towards major complications such as haemorrhage or serious intra-abdominal infections.

To date, the early diagnosis of pancreatic fistula is based on high levels of one pancreatic enzyme, amylase, in the drains. However in certain clinical situations, patients present post-operative fistulas with no elevation of amylase. And, on the contrary, increased amylase with no clinical consequences.

It is therefore necessary to identify another early early marker of pancreatic fistula that corresponds better to clinical signs.

In a preliminary study conducted in 65 patients, the investigators recently found that another pancreatic enzyme (lipase) could be a more pertinent marker of pancreatic fistula, but this requires confirmation in a greater number of patients.

The objective is to evaluate the diagnostic performance of lipase in the drains for the early detection of pancreatic fistula with clinical repercussions in the 30 days following the surgery.

The study consists in collecting at 4 different time points (D1, D3, D4 and D6) a tube of blood and a tube of drain liquid.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: HCL - Hôpital universitaire de la Croix Rousse

intervention_type: Biological

nom_etablissement: CHU DIJON BOURGOGNE

acronyme: LIPA-DRAIN

titre: Etude des enzymes pancréatiques dans les drains comme biomarqueurs précoces de fistule pancréatique post-opératoire

nom_porteur: FACY

prenom_porteur: Olivier


title: Optimisation of Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

acronym: ACRO-OPTIM

summary: The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for starting alternative strategies, and to describe the modalities and the global effectiveness of alternative strategies.

status: Terminated

lead_sponsor: Ipsen

location_facility: Hopital Neuro-Cardiologique, Fédération d'Endocrinologie


title: Histological Response Rate After Mastectomy and Immediate Breast Reconstruction at the End of Neoadjuvant Chemotherapy and Radiotherapy

acronym: HIST-RIC

summary:
At present, it is widely admitted not proposing immediate mammary reconstruction when an adjuvant radiotherapy is indicated because of the significant change of the cosmetic result (profit) and it whatever is the technique of reconstruction adopted. This is true all the more as it is about a reconstruction by prosthesis because of the prothetic died risk of hull(shell).

Teams proposed immediate mammary reconstructions to expanding (carrier) patients of carcinoma infiltrating, sometimes locally moved forward. For these patients, was not brought back(reported) by increase of the risk of local or remote relapse.

Two studies estimated afterward the feasibility of the mastectomy with immediate mammary reconstruction at the close of the chemotherapy and of the radiotherapy. The rate of morbidity is judged as acceptable. The rate of local second offense(recurrence) was similar to the patients benefiting from the classic therapeutic plan.

During an other study ( M-RIC), it was shown that the inversion of therapeutic sequence is possible and that by prescribing the chemotherapy and the radiotherapy before immediate mammary reconstruction, the morbidity is acceptable.

It is acquired that the chemotherapy néoadjuvant is equivalent to the post-operative chemotherapy as regards the global survival.

On the other hand, the rate of histological answer, according to subgroups, is very different. This rate can vary of 9 % for tumors RH +, negative Her2 in 45 % for tumors RH-, Her2 over expression. There are 33 % for the RH +, Her2 + and of 35 % for triple-negative.

The purpose of the investigators study is to estimate the rate of histological response during the inversion of therapeutic sequence to make sure of the oncologic safety(security), in particular by molecular subgroups, considering the heterogeneousness of the results(profits) after chemotherapy néoadjuvant only. Sataloff and Chevallier Classifications is the references and will be used here, but the investigators can also use Symmans classification in addition.

The rate of local and metastatic second offenses(recurrences) will also be estimated.

lead_sponsor: Institut Paoli-Calmettes

location_facility: Icm - Institut Regional Du Cancer de Montpellier

region: Provence-Alpes-Côte d'Azur

nom_etablissement: INSTITUT PAOLI CALMETTES

acronyme: HIST-RIC

titre: Taux de réponse HISTologique après mastectomie de clôture avec conservation de l'étui cutané et Reconstruction Immédiate par lambeau musculocutané de grand dorsal après chimiothérapie et radiothérapie dans les carcinomes infiltrants du sein.

nom_porteur: BANNIER

prenom_porteur: Marie


type: Registry Identifier

title: Impact of Ipsilateral Decubitus Forced Expiration On Duration of Pleural Drainage After Pulmonary Surgery in Children : Randomized Trial

acronym: KPDP

summary:
Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage.

Pleural effusion is responsible for pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude. These complications could be avoided by respiratory physiotherapy.

Forced expiration technic in ipsilateral decubitus is one of these technics but has never been proved better than other technics regarding its efficiency.

The aim of the study is to compare the impact of such a technic on post operative thoracic drainage after pulmonary, pleural or mediastinal pediatric surgery.

primary_purpose: Prevention

lead_sponsor: University Hospital, Tours

location_facility:
UH Tours
Hospices civiles Lyon
UH Marseille
Uh Nantes
UH of PARIS - NECKER Hospital
UH of PARIS - Robert Debre Hospital
UH BREST
UH of PARIS - KREMLIN BICETRE Hospital
Uh Angers
Uh Limoges

appel_a_projets: PHRIP

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

type_etablissement: CHUR

acronyme: KPDP

titre: Impact de l'expiration forcée en décubitus homolatéral sur la durée du drainage pleural après chirurgie pulmonaire chez l'enfant : essai randomisé

discipline_principale: médecine physique et réadaptation

nom_porteur: RETAILLEAU

prenom_porteur: Emilie


title: MabThera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An Infusion Centre-Based Approach

summary: This study is to characterize the indications for which rituximab is being used and to evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication for non-oncology conditions at infusion centers. The study involves the retrospective chart review of rituximab users' medical records in non-oncology indications as well as a survey to collect information on participant characteristics, and will include questions about participant knowledge on the risk of infections, participant receipt and review of the PAC, and any actions the participant has taken as a result of receiving the PAC.

time_perspective: Retrospective

ReferenceCitation: Sarsour K, Beckley-Kartey S, Melega S, Odueyungbo A, Kirchner P, Khalife N, Bangs J. Rituximab utilization for approved and off-label nononcology indications and patients' experiences with the Patient Alert Card. Pharmacol Res Perspect. 2020 Jan 3;8(1):e00555. doi: 10.1002/prp2.555. eCollection 2020 Feb.

publisher_dissemination: Wiley

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
United Kingdom
Spain
France

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Asst Centro Specialistico Ortopedico Traumato-Logico Gaetano Pini/Cto

location_facility: CIRI - Centrum für Innovative Diagnostik und Therapie GmbH

location_facility: Chu De Clermont Ferrand; Hopital Gabriel Montpied

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François Magendie

location_facility: Rheumazentrum Ratingen - Studienambulanz

location_facility: IDI-Istituto Dermopatico dell'Immacolata IRCCS

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte

location_facility: Hospital Clinico Universitario Valladolid

location_facility: Hospital Universitari de Bellvitge; Servicio de Reumatologia

location_facility: Universitaetsklinikum Freiburg; Innere Medizin II, Gastroenterologie

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Universitätsklinikum Schleswig-Holstein; Campus Lübeck

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliera Universitaria Arcispedale S. Anna

location_facility: Hospital Universitario Clínico San Carlos

location_facility: Hospital Regional Universitario de Malaga; Servicio de Reumatologia

location_facility: Azienda Ospedaliero Universitaria Pisana


type: EudraCT Number

title: REACTION: A Phase II Study of Etoposide and Cis/Carboplatin With or Without Pembrolizumab in Untreated Extensive Small Cell Lung Cancer

acronym: REACTION

summary: This is a multicenter, open-label, two armed, controlled, and randomized phase II trial investigating the activity of pembrolizumab in combination with standard chemotherapy in Extensive Disease (ED)-SCLC.

sponsor_collaborators: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
United Kingdom
France

location_facility: Centre Hopitalier Intercommunal De Creteil

location_facility: Centre Hospitalier d'Avignon - Hopital Duffaut

location_facility: Ospedale S. Luigi Gonzaga - Universita Di Torino

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Avicenne


title: Phase II Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma

acronym: iLOC

summary: The study is an open label, prospective, multicenter, phase II study which aims to define ibrutinib efficacy in patients with relapsed or refractory primary central nervous lymphoma (PCNSL) or intraocular lymphoma (IOL) as measured by the disease control (DC) rate (complete response (CR) + uncertain complete response (Ru) + partial response (PR) stabilized disease (SD)) after 2 cycles of treatment according to International study group for PCNSL (IPCG) criteria.

ReferenceCitation: Soussain C, Choquet S, Blonski M, Leclercq D, Houillier C, Rezai K, Bijou F, Houot R, Boyle E, Gressin R, Nicolas-Virelizier E, Barrie M, Molucon-Chabrot C, Lelez ML, Clavert A, Coisy S, Leruez S, Touitou V, Cassoux N, Daniau M, Ertault de la Bretonniere M, El Yamani A, Ghesquieres H, Hoang-Xuan K. Ibrutinib monotherapy for relapse or refractory primary CNS lymphoma and primary vitreoretinal lymphoma: Final analysis of the phase II 'proof-of-concept' iLOC study by the Lymphoma study association (LYSA) and the French oculo-cerebral lymphoma (LOC) network. Eur J Cancer. 2019 Aug;117:121-130. doi: 10.1016/j.ejca.2019.05.024. Epub 2019 Jul 3.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

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

repository_normalized: HAL

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
CHU de la Timone
Centre Léon Bérard
CHU de la Pitié Salpêtrière
CHU Brabois
CHU d'ESTAING
CHU de Grenoble
Hôpital René Huguenin Institut Curie
CHU de Rennes
CHRU de LILLE - Claude Huriez
Centre Henri Becquerel


title: Frequency of Occurrence of Dumping Syndrome After Operation of Esophageal Atresia Type III

acronym: DUMPING

summary: The purpose of this study is to evaluate the prevalence at 3.5 months of age of dumping syndrome in children operated at birth for oesophageal atresia type III et IV.

ReferenceType: result

ReferenceCitation: Bufler P, Ehringhaus C, Koletzko S. Dumping syndrome: a common problem following Nissen fundoplication in young children. Pediatr Surg Int. 2001 Jul;17(5-6):351-5. doi: 10.1007/s003830000525.

ReferenceCitation: Samuk I, Afriat R, Horne T, Bistritzer T, Barr J, Vinograd I. Dumping syndrome following Nissen fundoplication, diagnosis, and treatment. J Pediatr Gastroenterol Nutr. 1996 Oct;23(3):235-40. doi: 10.1097/00005176-199610000-00006.

ReferenceCitation: Zung A, Zadik Z. Acarbose treatment of infant dumping syndrome: extensive study of glucose dynamics and long-term follow-up. J Pediatr Endocrinol Metab. 2003 Jul-Aug;16(6):907-15. doi: 10.1515/jpem.2003.16.6.907.

ReferenceCitation: Ng DD, Ferry RJ Jr, Kelly A, Weinzimer SA, Stanley CA, Katz LE. Acarbose treatment of postprandial hypoglycemia in children after Nissen fundoplication. J Pediatr. 2001 Dec;139(6):877-9. doi: 10.1067/mpd.2001.119169.

ReferenceCitation: Michaud L, Sfeir R, Couttenier F, Turck D, Gottrand F. Dumping syndrome after esophageal atresia repair without antireflux surgery. J Pediatr Surg. 2010 Apr;45(4):E13-5. doi: 10.1016/j.jpedsurg.2010.01.016.

ReferenceCitation: Holschneider P, Dubbers M, Engelskirchen R, Trompelt J, Holschneider AM. Results of the operative treatment of gastroesophageal reflux in childhood with particular focus on patients with esophageal atresia. Eur J Pediatr Surg. 2007 Jun;17(3):163-75. doi: 10.1055/s-2007-965087.

ReferenceCitation: Aumar M, Gottrand F, Chalouhi C, Blanc S, Thomassin N, Piloquet H, Gastineau S, Schneider A, Krishnan U, Duvoisin G, Turck D, Coopman S, Michaud L. Frequency of Abnormal Glucose Tolerance Test Suggestive of Dumping Syndrome Following Oesophageal Atresia Repair. J Pediatr Gastroenterol Nutr. 2020 Jun;70(6):820-824. doi: 10.1097/MPG.0000000000002651.

oa_host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)

repositories_concat: HAL;LillOA (Lille Open Archive)

unpaywall_oa_status: green

location_facility: Hôpital Robert Debré ,Service de chirurgie viscérale et urologique

location_facility: Hôpital Edouard Herriot,Unité d'Hépatogastroentérologie et Nutrition Pédiatriques


title: Contribution of High-throughput Exome Sequencing in Fetopathology

acronym: FOETEX

summary:
This research concerns the contribution of a new examination, high-throughput exome sequencing, in the diagnosis of the cause of polymalformative fetal syndromes. With currently available examinations, the causes of polyformative syndromes, which correspond to the association of several congenital malformations with varying degrees of severity in different organs, remain unknown in a large number of cases.

High-throughput exome sequencing (HTES) is a diagnostic tool that allows the simultaneous analysis of all of the coding parts of DNA. This examination has already shown its superior diagnostic capability in every post-natal diagnostic context, in particulier in infants with malformations associated or not with intellectual deficiency. Its contribution has not yet been studied in a large number of fetuses with polymalformations. To investigate the usefulness of HTES, we propose to carry out the examination in 100 fetuses with polymalformations, as well as the usual examinations including chromosomal microarray analysis and possibly the study of specific genes that may explain these malformations. A blood sample will be taken from both parents to allow interpretation of the results.

location_facility:
CHRU de Reims (Hôpital Maison Blanche)
CH de Mulhouse (Hôpital Emile Muller)
CHU Montpellier
CHU de NANCY
CHU de Clermont-Ferrand
CHU de DIJON
CHRU de Tours
CHU de Rennes
CHU de STRASBOURG (Hôpital Hautepierre)
CHU de Rouen

acronyme: FOETEX

titre: Apport diagnostique du séquençage haut débit d'exome en foetopathologie

nom_porteur: THEVENON

prenom_porteur: Julien


title: Multicenter Phase II Study of Axitinib in First Line Treatment for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)

acronym: AXIPAP

summary: Multicenter, single arm, phase II study using a A'Hern single-stage procedure in patients with locally advanced or metastatic papillary renal cell carcinoma (PRCC) in first-line treatment.

ReferenceCitation: Negrier S, Rioux-Leclercq N, Ferlay C, Gross-Goupil M, Gravis G, Geoffrois L, Chevreau C, Boyle H, Rolland F, Blanc E, Ravaud A, Dermeche S, Flechon A, Albiges L, Perol D, Escudier B; GETUG collaborative group. Axitinib in first-line for patients with metastatic papillary renal cell carcinoma: Results of the multicentre, open-label, single-arm, phase II AXIPAP trial. Eur J Cancer. 2020 Apr;129:107-116. doi: 10.1016/j.ejca.2020.02.001. Epub 2020 Mar 5.

lead_sponsor: Centre Leon Berard

location_facility:
ICO - René Gauducheau
Institut Claudius Regaud
ICO Paul Papin
Institut Paoli Calmettes
ICL
Gustave Roussy
Centre Leon Berard
Centre Geogres François Leclerc
Chu Bordeaux
Centre Francois Baclesse


title: Determining Biomechanical and Morphological Factors That Affect Children With Duchenne Muscular Dystrophy (DMD) Who Loss of the Ability to Walk

acronym: MARCHE-DMD

summary: The loss of ability to walk in many children with DMD (Duchenne muscular Dystrophy) is a pejorative event. Biomechanical and morphological unknowledge about the loss of the walk ability in children with DMD is an obstacle in reeducative, pharmacological or surgical therapeutic targets.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: University Hospital, Brest

location_facility:
CH Le Mans
CHU
CHRU
CHBA
CHU de Nantes


title: Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis (RA) to Adapt Treatment

acronym: BCD

summary:
This study compares different methods of clinical evaluation (C) and/or ultrasound (B or D) concerning the rheumatoid arthritis in order to monitore the treatment. This study will provide the exact number of patients in remission according the 3 methods.

It could allow to assess the concordance between the 3 evaluated methods. This study will permit to define the best method which limit the evolution of structural damages ( principal criteria).

location_facility:
CHU SUD Rennes
CH Le Mans
CHRU Brest
CHU Nantes
CHR Orléans
CHU La Roche sur Yon
CH Vannes
CH de Lorient
CHU Tours
CHU Angers

intervention_type: Device

region: Bretagne

nom_etablissement: CHRU BREST

acronyme: BCD

titre: Etude pragmatique comparant les méthodes d'évaluation clinique (C) et/ou échographique (mode B ou D) de la polyarthrite rhumatoïde pour guider l'adaptation thérapeutique

discipline_principale: rhumatologie

nom_porteur: JOUSSE-JOULIN

prenom_porteur: Sandrine


title: Multicenters, Randomised Clinical Trial, to Evaluate Efficacy and Compliance of Mandibular Advancement Devices ONIRIS® vs. Laboratory Devices TALI in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas

acronym: IRIS

summary: To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use. Sleeping tests were performed.

ReferenceCitation: Pepin JL, Raymond N, Lacaze O, Aisenberg N, Forcioli J, Bonte E, Bourdin A, Launois S, Tamisier R, Molinari N. Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial. Thorax. 2019 Jul;74(7):667-674. doi: 10.1136/thoraxjnl-2018-212726. Epub 2019 May 3.

evidence: open (via free pdf)

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

version: submittedVersion

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

unpaywall_oa_status: bronze

lead_sponsor: ONIRIS

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Evaluation of Cryoprotection of Nail Toxicity Induced by Docetaxel Low Cumulative Dose. Controlled, Randomized, Open, Multicentre Prospective.

acronym: BANQUISE

summary:
For the specific patient population studied receiving 5-Fluorouracil, epirubicin and cyclophosphamide - Docetaxel sequence (cumulative dose <300 mg / m2), using a cryoprotection has never been assessed.

The effectiveness of cryoprotection of onycholysis secondary to Docetaxel is not well established in this population (breast cancer in the adjuvant setting) and is based solely on a publication (Scotté) that does not contain the same therapeutic modalities (dose significantly higher). The few studies available have heterogeneous populations, nonrandomized, retrospective or with a small sample.

By extension to what has been observed with higher cumulative doses of docetaxel, some teams offer mittens and booties chilled to their patients, a practice that is not the subject of a national consensus.

The investigators wish to accurately assess the effectiveness of mittens and slippers chilled, their tolerance and their observance because of weak data on this specific population in the literature.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility: Institut de cancérologie de l'Ouest - Nantes

location_facility: Institut de cancérologie de l'Ouest - Angers


title: Expanded Access Program for a Multicentre, Open, Non Randomized Study, Evaluating Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase

acronym: EAP

summary: Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.

status: No longer available

study_type: Expanded Access

lead_sponsor: ERYtech Pharma

location_facility:
CHU Saint Etienne Hôpital Nord
Hôpital Jean Minjoz - Batiment MEMCP
Hôpital Saint Louis
CHU Rouen - Hôpital des enfants
CHRU Lille - Hôpital Claude-Huriez
Hôpital de l'Archet 2
Institut Universitaire du Cancer
Hôpital BRETONNEAU
Hôpital Brabois Enfants
IHOP


title: Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease

acronym: CHANCE

summary:
The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies.

Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of small bowel mucosal healing by conventional colonoscopy is an invasive technique which is not complete since it does not allow exploration of the small bowel beyond the terminal ileum (TI). Thus, direct evidence of the healing of the majority of the small bowel is lacking.

primary_purpose: Diagnostic

ReferenceCitation: Sands B.E. Crohn's Disease. Sleisenger and Fortran's Gastrointestinal and Liver Disease. 8th edition; Volume 2; Saunders Elsevier Publisher; Canada. 2006. pps 2459-2498.

ReferenceCitation: Lichtenstein G.R. The Clinician's Guide to Inflammatory Bowel Disease. Slack Publishers, New Jersey 2003. pps 1-7;16-19; 41-57.

ReferenceCitation: Kornbluth A, Colombel JF, Leighton JA, Loftus E; ICCE. ICCE consensus for inflammatory bowel disease. Endoscopy. 2005 Oct;37(10):1051-4. doi: 10.1055/s-2005-870315. No abstract available.

ReferenceCitation: Engstrom P.F. Goosenberg E.B. Diagnosis and Management of Bowel Disease. 1st edition. Professional Communications, Inc. Publisher. Oklahoma. 1999. pps. 169-185.

ReferenceCitation: Sipponen T, Savilahti E, Kolho KL, Nuutinen H, Turunen U, Farkkila M. Crohn's disease activity assessed by fecal calprotectin and lactoferrin: correlation with Crohn's disease activity index and endoscopic findings. Inflamm Bowel Dis. 2008 Jan;14(1):40-6. doi: 10.1002/ibd.20312.

ReferenceCitation: Sostegni R, Daperno M, Scaglione N, Lavagna A, Rocca R, Pera A. Review article: Crohn's disease: monitoring disease activity. Aliment Pharmacol Ther. 2003 Jun;17 Suppl 2:11-7. doi: 10.1046/j.1365-2036.17.s2.17.x.

ReferenceCitation: Lewis BS, Eisen GM, Friedman S. A pooled analysis to evaluate results of capsule endoscopy trials. Endoscopy. 2005 Oct;37(10):960-5. doi: 10.1055/s-2005-870353. Erratum In: Endoscopy. 2007 Mar;39(4):303.

ReferenceCitation: Mow WS, Lo SK, Targan SR, Dubinsky MC, Treyzon L, Abreu-Martin MT, Papadakis KA, Vasiliauskas EA. Initial experience with wireless capsule enteroscopy in the diagnosis and management of inflammatory bowel disease. Clin Gastroenterol Hepatol. 2004 Jan;2(1):31-40. doi: 10.1016/s1542-3565(03)00289-1.

ReferenceCitation: Dray X, Vahedi K, Valleur P, Marteau P. Is there any need for video capsule endoscopy evaluation in postduodenal small-bowel polyps detection in familial adenomatous polyposis? Gastrointest Endosc. 2007 Sep;66(3):634; author reply 634-5. doi: 10.1016/j.gie.2007.04.008. No abstract available.

ReferenceCitation: Dionisio PM, Gurudu SR, Leighton JA, Leontiadis GI, Fleischer DE, Hara AK, Heigh RI, Shiff AD, Sharma VK. Capsule endoscopy has a significantly higher diagnostic yield in patients with suspected and established small-bowel Crohn's disease: a meta-analysis. Am J Gastroenterol. 2010 Jun;105(6):1240-8; quiz 1249. doi: 10.1038/ajg.2009.713. Epub 2009 Dec 22.

ReferenceCitation: van Assche G, Vermeire S, Rutgeerts P. Mucosal healing and anti TNFs in IBD. Curr Drug Targets. 2010 Feb;11(2):227-33. doi: 10.2174/138945010790309902.

ReferenceCitation: D'haens G, Van Deventer S, Van Hogezand R, Chalmers D, Kothe C, Baert F, Braakman T, Schaible T, Geboes K, Rutgeerts P. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: A European multicenter trial. Gastroenterology. 1999 May;116(5):1029-34. doi: 10.1016/s0016-5085(99)70005-3.

ReferenceCitation: Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4.

ReferenceCitation: Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.

ReferenceCitation: Rutgeerts P, Diamond RH, Bala M, Olson A, Lichtenstein GR, Bao W, Patel K, Wolf DC, Safdi M, Colombel JF, Lashner B, Hanauer SB. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest Endosc. 2006 Mar;63(3):433-42; quiz 464. doi: 10.1016/j.gie.2005.08.011.

ReferenceCitation: Dubcenco E, Jeejeebhoy KN, Petroniene R, Tang SJ, Zalev AH, Gardiner GW, Baker JP. Capsule endoscopy findings in patients with established and suspected small-bowel Crohn's disease: correlation with radiologic, endoscopic, and histologic findings. Gastrointest Endosc. 2005 Oct;62(4):538-44. doi: 10.1016/j.gie.2005.06.026.

ReferenceCitation: Postgate AJ, Burling D, Gupta A, Fitzpatrick A, Fraser C. Safety, reliability and limitations of the given patency capsule in patients at risk of capsule retention: a 3-year technical review. Dig Dis Sci. 2008 Oct;53(10):2732-8. doi: 10.1007/s10620-008-0210-5. Epub 2008 Mar 5.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_country: Spain France

location_facility:
Hôpital Brabois
Hôpital Huriez
Hôpital Hôtel Dieu
CHU Kremlin Bicêtre
Hôpital Archet 2
CHU CAEN
Hospital Clinic
Hôpital St Louis
Hôpital Beaujon
CHU Clermont Ferrand
CHU Amiens


acronym: CONSTELLATION

lead_sponsor: Novartis Pharmaceuticals

summary: The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.

title: A 24 Month Open-label, Multicenter, Phase IIIb Study of the Efficacy and Safety of Lucentis® (Ranibizumab 0,5mg) in Diabetic Patients With Visual Impairment Due to Macular Edema Evaluating a Spaced Out Follow-up After Intensive Loading Phase

source: euctr


title: Essai de Phase IV, Multicentrique, Ouvert, Visant à Tester la différence d'efficacité du Natalizumab, Versus le Fingolimod, 2 médicaments Ayant Une AMM Pour le Traitement de la sclérose en Plaques

acronym: BEST-MS

summary: Under the escalation treatment strategy when a patient displays breakthrough disease parameters under first line therapy, MS physicians are allowed by the EMEA to switch for Natalizumab (NTZ) or fingolimod (FGL). NTZ and FGL efficacy have been demonstrated by randomized therapeutic trial. As both treatments have been tested versus placebo a common way to compare them is to look at their respective annualized relapse risk ratio decrease. Roughly NTZ decrease by 70% and FGL by 50%. Nevertheless it is a terrible comparison since the placebo group had different behaviour in the 2 trials and the patients demographic features at baseline are also different. Therefore, it is right now totally impossible to compare these 2 drugs with a decent methodology. Only a head-to-head comparison could do it. Unfortunately this head-to-head comparison is not available and will not probably be done under the drug companies initiative. During the time of this study, we will perform a phase IV, observational, prospective head-to-head comparison of NTZ versus FGL efficacy in 600 patients. Our primary end point will be disease free patients after 1 year of treatment. Further, this trial will allow us to collect new biological samples, useful for a validation our project main aim. Further these new samples will be obtained from 3 European countries, which is a must if we want to generalize our conclusion obtained from a French cohort. Cooperation at the European level is thus essential for the implementation of this project .

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
European Commission

location_country: Germany Spain France

location_facility:
CHU Nantes
Chu La Timone
Chu Lille
CHU Nîmes
CHU Nice
Université de Muenter
Hôpital Vall D'Hebron
CHU Besançon
CHRU Strasbourg
CHU Bordeaux
CHU Caen
CHU Nancy


title: WEB French Observatory

summary: An observational post-market, open label, multicenter Observatory. The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory.

lead_sponsor: Microvention-Terumo, Inc.

location_facility:
CHU Purpan
CHU Beaujon
CHU La Miletrie
CHU Reims - Hôpital Maison-Blanche
Hôpital Nord Laennec
CHU Pellegrin
CHU Bretonneau
CHU Pontchailloux
CHU Côte de Nacre
Hôpital Neurologique Pierre Wertheimer


title: Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.

summary: Patients with metastatic breast cancer considered HER2 negative are screened for HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II with an adaptive design.

ReferenceCitation: Jacot W, Cottu P, Berger F, Dubot C, Venat-Bouvet L, Lortholary A, Bourgeois H, Bollet M, Servent V, Luporsi E, Espie M, Guiu S, D'Hondt V, Dieras V, Sablin MP, Brain E, Neffati S, Pierga JY, Bidard FC. Actionability of HER2-amplified circulating tumor cells in HER2-negative metastatic breast cancer: the CirCe T-DM1 trial. Breast Cancer Res. 2019 Nov 14;21(1):121. doi: 10.1186/s13058-019-1215-z.

publisher_dissemination: Springer-Nature

lead_sponsor: Institut Curie

location_facility:
Centre Oscar Lambret
Institut de Cancérologie de Lorraine
Chu Saint-Louis
Centre Catherine de Sienne
Centre Val d'Aurelle - P. Lamarque
Chu de Limoges
Institut de Cancérologie HARTMANN
Institut Curie - Hôpital René HUGENIN
Clinique Victor Hugo
Institut Curie


title: Depression in the Elderly and Cerebral Amyloid Plaques: Characterization by [18F] AV-45 Affectives Symptoms and Amyloïd Plaques (ASAP)

acronym: ASAP

summary: The primary objective of the study is to compare the brain amyloid load in fully, partially and non remitting depressed elderly patients at 8 weeks of antidepressant therapy, by using PET with [F18]AV45.

location_facility: University Hospital of Toulouse - Purpan

location_facility: University hospital of Rennes-Guillaume Régnier

location_facility: University Hospital of Besançon- Jean Minjoz


title: Phase II Study of Vismodegib in Patients With Refractory or Relapsed B-cell Lymphoma or Chronic Lymphocytic Leukemia

acronym: VISMOLY

summary: The purpose of this study is to determine the efficacy of Vismodegib drug in treatment of patients with relapsed or refractory B-cell lymphoma or chronic lymphocytic leukemia (CLL).

sponsor_collaborators: The Lymphoma Academic Research Organisation

location_facility:
Hôpital Saint-Louis
Hôpital Henri MONDOR
CH Lyon Sud
CHRU de Lille _ Hôpital Huriez
Hôpital René Huguenin _ Institut Curie
CHU de Nantes _ Hôtel Dieu
CHU Pontchaillou
CHU Dijon _ Hôpital d'Enfants
CHU Haut Lévèque
Centre Henri Becquerel


lead_sponsor: Nantes University Hospital

summary:
This is a phase II, multicenter, open-label study to evaluate the safety and efficacy of MLN9708 in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed multiple myeloma. The patient population will consist of adult men and women younger than 66 years, who have a confirmed diagnosis of MM who meet eligibility criteria.

Following the screening period, patients will be enrolled and treated then, they will receive induction therapy (3 cycles), a systematic Peripheral Blood Stem Cell harvest. After Peripheral Blood Stem Cell Transplantation, patient will enter in the consolidation phase (early and late one) 2 months after transplantation. Finally, patients follow a Maintenance therapy (start 1 month after the last cycle of consolidation) during 12 months.

location_facility:
Centre hospitalier départemental Vendée
Pole IUC Oncopole CHU
CHRU - Hôpitaux de Brabois
Nantes University Hospital
CHRU - Hôpital Claude Huriez
CHRU Dijon
Centre Hospitalier Lyon sud
CHRU - Hôpital du Haut Lévêque
CHRU - Hôpital Bretonneau
Hôpital Saint-Antoine

title: Phase II Trial Studying the Efficacy of a Triplet Combination of MLN9708, Lenalidomide and Dexamethasone as Induction Prior to, and as Consolidation After High-dose Therapy With Peripheral Stem Cell Transplantation Followed by MLN9708 Maintenance in the Initial Management of Multiple Myeloma in Patients Younger Than 66 Years


title: Prospective Study Assessing the Feasibility of Interval Debulking Surgery by Laparoscopy for Peritoneal Carcinomatosis of Ovarian Origin, Tubal or Primary Peritoneal, in Chemosensitive Patients Treated by Neoadjuvant Chemotherapy.

acronym: CILOVE

summary: This prospective nonrandomized multicenter phase II study, will evaluate the possibility of performing a laparoscopic interval debulking after a minimum of 3 cycles of chemotherapy in highly chemo-sensitive patients with advanced ovarian, tubal cancer or primary peritoneal.

lead_sponsor: Centre Jean Perrin

location_facility: Institut de Cancerologie de l'Ouest, site Paul Papin


title: Study of Anatomical and Functional Recovery Following Retinal Detachment: Identify Correlations Between Visual Acuity and SD-OCT and Microperimetry Findings.

acronym: DOREFA

summary:
Patients with retinal detachment do not always recover good visual function. Sometimes simple causes are responsible. Other causes can only be discovered thanks to high-resolution imaging provided by the latest generation of OCT.

This study is possible thanks to surgical teams who have a strong recruitment potential, with the experience of a joint project in 2007-2008 (PHRC national - Etude DOREMY, Etude FRIENDS) to define more strict intervention criteria. The principal objective of this study is to better define with regard to time:

The onset of surgically curable or transient macular affections, and losses in visual acuity that can be qualified as "explained"
But above all to better understand the relationships between anatomical analyses obtained using OCT and autofluorescence and functional analysis using visual acuity and microperimetry.
In the near future, two techniques (OCT and microperimetry) will certainly become essential tools in the evaluation of macular function. Better understanding of these relationships is the first necessary step in any study concerning the therapeutic prevention of retinal lesions related to retinal detachment: This study will make it possible to define criteria for the evaluation of anatomical and functional recovery, their relationship with each other and finally their evolution over time. This is an essential first phase before possible therapies can be evaluated.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Role of Intrathecal Chemotherapy With Liposomal Cytarabine (DepoCyte®) in Patients Wih Leptomeningeal Metastasis of Breast Cancer. A Randomized Phase III Study.

acronym: DEPOSEIN

summary: The purpose of this study is to evaluate the impact of Depocyte® IT combined with the systemic standard treatment in terms of clinical and/or radiological neuromeningeal progression free survival (SSPN)

ReferenceCitation: Le Rhun E, Wallet J, Mailliez A, Le Deley MC, Rodrigues I, Boulanger T, Lorgis V, Barriere J, Robin YM, Weller M, Bonneterre J. Intrathecal liposomal cytarabine plus systemic therapy versus systemic chemotherapy alone for newly diagnosed leptomeningeal metastasis from breast cancer. Neuro Oncol. 2020 Apr 15;22(4):524-538. doi: 10.1093/neuonc/noz201.

evidence: open (via free article)

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_concat: PubMed Central;www.zora.uzh.ch

publisher_dissemination: Oxford University Press

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Hospitalier Universitaire Groupe Sud

location_facility: Centre Hospitalier Universitaire de Nice


title: Evaluation of Patient Satisfaction With and Acceptance of Their Totally-implanted Central Venous Catheter: Confirmatory Validation of QASICC Questionnaire

acronym: QASICC-EVA

summary:
Background Patient satisfaction with or acceptance of care assessment is increasingly taken into account in oncology. Most cancer and other critically-ill patients require a totally-implanted Central Venous Catheter (CVC) for their treatment consisting of a reservoir connected to a central venous catheter, which may or may not be valved. It is impossible to estimate the number of CVC used in oncology. However, some authors claim that, in 2005, over 7 million CVCs were placed in the United States in both chronic and acute care. Although many patients fitted with a CVC are able to undertake activities which are hindered with other external vascular access devices, they are often physically or psychologically anxious about their device. To our knowledge, no validated questionnaire measuring patient acceptance of and satisfaction with their CVC has been reported in the literature. Based on these observations, the aim of our study was to develop and to validate a French-language questionnaire dubbed QASICC (Questionnaire for Acceptance of and Satisfaction with Implanted Central Venous Catheter) assessing patient satisfaction with and acceptance of their CVC. QASICC is designed as a multi-dimensional, self-administered questionnaire comprising approximately 30 items related to the use, appearance and pros and cons of the device as well as quality of life as perceived by patients using one for treatment.

Objective The purpose of the study is to validate a French-language self-administered questionnaire (QASICC) designed to evaluate patients' satisfaction and acceptance concerning their totally-implanted central venous catheter: confirmatory validation of questionnaire psychometric properties.

Study Design This is a prospective, multicenter, open study.

Primary Outcome Measures:

Questionnaire's 27 items tested on 990 patients to confirm QASICC internal structure:

Items quality
Dimensional structure
Dimensional consistence
Measure accuracy
Measure reliability
Sensitivity to change

lead_sponsor: Centre Antoine Lacassagne

location_facility:
Chu La Timone
Centre Antoine Lacassagne
Institut Claudius Regaud
Chu de Montpellier
Centre Paul Papin - Ico
Centre Paul Strauss
Institut Jean Godinot
Centre Rene Huguenin
Centre Alexis Vautrin
Centre Francois Baclesse


title: Preliminary Study Evaluating Deep Brain Stimulation of Nucleus Accumbens in Patients Suffering From Chronic and Resistant Major Depressive Disorder

acronym: PRESTHYM

summary: Depression is a common, recurrent and disabling disorder. Among patients with a chronic course of the disease, 20 to 30% are resistant to antidepressant medications. Among those patients, 50% would not benefit from electroconvulsive therapy (ECT). For such patients, deep brain stimulation (DBS) of nucleus accumbens is considered.

ReferenceCitation: Millet B, Jaafari N, Polosan M, Baup N, Giordana B, Haegelen C, Chabardes S, Fontaine D, Devaux B, Yelnik J, Fossati P, Aouizerate B, Krebs MO, Robert G, Jay T, Cornu P, Verin M, Drapier S, Drapier D, Sauleau P, Peron J, Le Jeune F, Naudet F, Reymann JM. Limbic versus cognitive target for deep brain stimulation in treatment-resistant depression: accumbens more promising than caudate. Eur Neuropsychopharmacol. 2014 Aug;24(8):1229-39. doi: 10.1016/j.euroneuro.2014.05.006. Epub 2014 May 20.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

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

lead_sponsor: Rennes University Hospital

location_facility: Grenoble University Hospital (Nord Hospital)


title: Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer

acronym: CEOLE

summary: The aim of this study is to culturally adapt and to validate Quality Of Life tools dedicated to the end of life for French cancer patients.

primary_purpose: Supportive Care

ReferenceCitation: Poirier AL, Kwiatkowski F, Commer JM, D'Aillieres B, Berger V, Mercier M, Bonnetain F. Health-related quality of life in cancer patients at the end of life, translation, validation, and longitudinal analysis of specific tools: study protocol for a randomized controlled trial. Trials. 2012 Apr 20;13:39. doi: 10.1186/1745-6215-13-39.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Institut Bergonié
Centre Antoine Lacassagne
CHU
ICO Paul Papin
Centre Hospitalier
CHU Minjoz
Centre Oscar Lambret
Centre Georges François Leclerc
Centre Alexis Vautrin
Centre Val d'Aurelle Paul Lamarque


title: Clinical, Biological, Genetic and Functional Characterization of Rare Iron Overload Phenotypes Associated With Hepcidin Deficiency Except C282Y Homozygosity.

acronym: HEPCIDEF

summary: Chronic iron overload is responsible for morbidity and mortality. There are many genetic and acquired causes. One of them is an hepcidin deficiency. Hepcidin is the regulating hormone for iron. The study explores this specific cause, and aim to characterize this iron overload in term of clinical, biological, genetic and functional specificities.

location_facility:
Purpan CHU
Emilie Muller Hospital
CHRU - Huriez Hospital
Hospital of conception
Lyon Sud Hospital
Hospital Center
Saint Eloi Hospital - CHU
BP 86709
Kremlin-Bicêtre Hospital
Limoges CHU


title: Comparison of Gastric By-Pass and Optimized Medical Treatment in Obese Diabetic Patients in Terms of Mortality, Glycemic Control, and Cost Effectiveness - Prospective, Multicenter, Randomized Study

acronym: DIABSURG

summary: The objectives are to compare the results of the Gastric By-Pass (GBP) to that of optimized medical therapy in patients with obesity and poorly controlled type 2 diabetes in terms of mortality, weight loss, glycemic control, quality of life, cost, cost-effectiveness and cost utility of these two strategies.

status: Recruiting

lead_sponsor: University Hospital, Lille

location_facility:
Hopital de Bois-Guillaume Chu Rouen
Hu Ouest Site Ambroise Pare Aphp -
University Hospital of Lille
Hopital Larrey Chu Toulouse
Hopital Jeanne D'Arc Chu Nancy
Hu Pitie Salpetriere Aphp
Ch Valenciennes
Centre Hospitalier Regional D' Angers
Hopital Lyon Sud - Hcl - Pierre Benite
Hopital Lapeyronie Chu Montpellier


acronym: HPV-071 PRI

lead_sponsor: GlaxoSmithKline

summary: The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6 months in 9-14 years old healthy females.

ReferenceCitation: Leung TF, Liu AP, Lim FS, Thollot F, Oh HM, Lee BW, Rombo L, Tan NC, Rouzier R, Friel D, De Muynck B, De Simoni S, Suryakiran P, Hezareh M, Folschweiller N, Thomas F, Struyf F. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine administered according to 2- and 3-dose schedules in girls aged 9-14 years: Results to month 12 from a randomized trial. Hum Vaccin Immunother. 2015;11(7):1689-702. doi: 10.1080/21645515.2015.1050570.

ReferenceCitation: Leung TF, Liu AP, Lim FS, Thollot F, Oh HML, Lee BW, Rombo L, Tan NC, Rouzier R, De Simoni S, Suryakiran P, Hezareh M, Thomas F, Folschweiller N, Struyf F. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and 4vHPV vaccine administered according to two- or three-dose schedules in girls aged 9-14 years: Results to month 36 from a randomized trial. Vaccine. 2018 Jan 2;36(1):98-106. doi: 10.1016/j.vaccine.2017.11.034. Epub 2017 Nov 23.

title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below).

location_country:
Hong Kong
Sweden
Singapore
France

ipd_sharing: Yes


acronym: IgES

lead_sponsor: Centre Francois Baclesse

summary: The main objective of this study is to validate the utility of IgE anti-cetuximab in the treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe reactions.

sponsor_collaborators:
Centre Francois Baclesse
University Hospital, Caen

location_facility:
Centre hospitalier
CHU
CHU Charles Nicolle
CHRU Lille
Centre Georges-François Leclerc
Centre Oscar Lambret
Centre Paul Strauss
Centre François Baclesse
Centre Henri Becquerel

title: Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab


summary:
Amyloid plaques and neurofibrillary tangles are the 2 well-known etiopathological hallmarks of Alzheimer's disease (AD). Beside these 2 lesions, inflammation response is described in the brain of patients with AD.

The main objective of our study is to analyse the correlation between the value of plasma cytokines (interleukin 1, 6, TNFα and chemochine Rantes) and the rapidity of the cognitive decline in AD over a 2-year follow-up.

Secondary objectives include:

the predictive value of the cytokines on the cognitive decline after 6 months and one year of follow-up., of the patients include 150 patients with AD (MMSE: 16-25)
correlation between plasma cytokines levels and expression of the protein kinase PKR (involved in death cell) in blood mononuclear cells.

lead_sponsor: Poitiers University Hospital

location_facility: CHU DE NANTES - Centre ambulatoire de Gérontologie clinique

location_facility: CHU Angers - service Gérontologie clinique


title: Standard Stapling Technique Versus Bipolar Fusion (With The Ligasure Impact and Force Triad Generator) To Complete The Fissure During Major Lung Resection: A Prospective Randomized Controlled Trial

summary: Surgical staplers have become standard for ligation, division, resection, anastomosis and closure in many surgical procedures. Staplers are utilized in thoracic surgery routinely for pulmonary parenchymal resection and closure, ligation of vessels and bronchi. In addition, closure of incomplete fissure/s is a frequent need in pulmonary surgery. Although generally safe and efficacious, staplers and staple loads are expensive, and can result in micro air leaks. The LigaSure Vessel Sealing System presents as a potentially faster and less expensive alternative to staplers. The LigaSure Vessel sealing system utilizes a combination of heat generated via bi-polar radiofrequency energy and precise jaw pressure to denature the collagen and elastin in tissue and blood vessels. The newly released Force Triad Generator and the Impact, a 10 mm jaw sealing device (Ligasure system, COVIDIEN Society) may offer improved performance in terms of tissue sticking due to an improved sealing algorithm, and to the jaw configuration of the Impact. The study main objective is to compare the quality of parenchymal pneumostasis after fissure closure achieved with staplers vs that achieved with LigaSure.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: CHU Clermont Ferrand - Service of Thoracic Surgery

location_facility: Department of Thoracic Surgery, Hospital Larrey, CHU Toulouse

location_facility: CHU Grenoble - Department of Vascular and Thoracic Surgery

location_facility: CHU Nice - Pasteur Hospital - Department of Thoracic Surgery

location_facility: Hospital Dupuytren - Department of Thoracic and CardioVascular Surgery

location_facility: CHU Lyon-Department of Thoracic Surgery, Cardiovascular and Chest Hospital

location_facility: CHU Marseille - Department of Thoracic Surgery

location_facility: CHU Strasbourg - Service of Thoracic Surgery


lead_sponsor: Centre Hospitalier Universitaire de Nice

summary:
Pulsed dye laser (PDL)is the gold standard treatment of port wine stains (PWS). However, many sessions are required and failure or relapses are not uncommon. It has been demonstrated that a neoangiogenesis occurs after PDL, explaining at least partially those failure. The objective of this study is to evaluate the use of a topical beta-blocker (timolol 1% gel) as a combination treatment with PDL for treating PWS.

Methods. Prospective multicenter study comparing PDL alone to PDL + timolol. Sessions of PDL will be performed once a month for 3 months. One group will be treated with PDL alone and the other will also applied timolol 1% gel twice a day during treatment. The evaluation will be done one month after the third session.

location_facility:
CHU de Nice - 4 avenue Reine Victoria
CHU de reims
CHU de Dijon
Clinique Mathilde
CHU de Touloluse
Clinique Saint-jean Languedoc
Hôpital Sévigné
CH de Quimper
Clinique de Turin
CHU de Bordeaux

title: Treatment of Port Wine Stains in Children With Pulsed Dye Laser and Timolol Gel


title: Cochicine Treatment for Post- Operative Pericardial Effusion: The POPE 2 Study A Multicenter, Double-blind, Randomized Trial

summary:
Background: The incidence of asymptomatic pericardial effusion is high after cardiac surgery.

Objective: To assess whether colchicine is effective in reducing post operative pericardial effusion volume.

Design: Multicenter, randomized, double-blind, placebo-controlled study. Intervention : colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by echocardiography) more than 7 days after cardiac surgery.

Measurements: The main end point will be change in effusion grade after 14 days of treatment. Secondary endpoints include frequency of late cardiac tamponade.

ReferenceCitation: Meurin P, Lelay-Kubas S, Pierre B, Pereira H, Pavy B, Iliou MC, Bussiere JL, Weber H, Beugin JP, Farrokhi T, Bellemain-Appaix A, Briota L, Tabet JY; French Society of Cardiology. Colchicine for postoperative pericardial effusion: a multicentre, double-blind, randomised controlled trial. Heart. 2015 Nov;101(21):1711-6. doi: 10.1136/heartjnl-2015-307827. Epub 2015 Jun 15.

lead_sponsor: French Cardiology Society

sponsor_collaborators:
French Cardiology Society
French Federation of Cardiology

location_facility:
Clinique de Châtillon
Clinique les Grands Près
Hopital Corentin Celton
Bois Gibert
Clinique de la mitterie
Centre Médical de Bligny
Clinique Iris
Centre Dieulefit Santé
Maison du mineur
Centre Hospitalier Loire Vendée Océan


title: A Multicenter, Open-label, Randomized, Controlled, Two-arm Study to Assess Compliance With Daily Tablet Intake of Women on Treatment With the Oral Contraceptive SH T00186D/BAY 86-5300 (0.02 mg Ethinyl Estradiol as Betadex Clathrate and 3 mg Drospirenone) in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function Over 12 Months

summary: The objective of the study is to evaluate the effect of the dispenser's buzzer function on compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP) containing oral contraceptive (OC) in a flexible extended regimen when administered for approximately 12 months to healthy female volunteers who request contraception.

lead_sponsor: Bayer


acronym: NATAIR

lead_sponsor: Novartis Pharmaceuticals

summary: This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.

ReferenceCitation: Garcia G, Magnan A, Chiron R, Contin-Bordes C, Berger P, Taille C, Devouassoux G, de Blay F, Couderc LJ, Didier A, O'Callaghan DS, Girodet PO, Bourdeix I, Le Gros V, Humbert M. A proof-of-concept, randomized, controlled trial of omalizumab in patients with severe, difficult-to-control, nonatopic asthma. Chest. 2013 Aug;144(2):411-419. doi: 10.1378/chest.12-1961.

title: A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy

primary_purpose: Basic Science


acronym: ReSPONSE

lead_sponsor: Pfizer

summary:
This study proposes to compare 2 different methods for managing a subject with psoriasis who has achieved good disease control, as defined by a clinical response with a Physician Global Assessment (PGA) inferior or equal to 1 at the screening visit, on etanercept treatment.

The first method involves stopping etanercept treatment on entry into the study, with the option to reinitiate etanercept at 50 mg once weekly after medical review and agreement between the subject and the investigator. The second method involves continuing on etanercept at 25 mg once weekly, with the option to increase the dose to 50 mg once weekly after medical review and agreement between the subject and the investigator. Subjects will be randomized into one of these two study arms.

location_facility: Ege Universitesi Tip Fakultesi Dermatoloji Anabilim Dali

location_facility: Universitätsklinikum-Eppendorf Martinistr. 20, Hamburg 20158

location_facility: Centre Hopitalier St Jacques (Place St Jacques)

location_facility: Papageorgiou General Peripheral Hospital of Thessaloniki

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: SZTE, Szent-Gyorgyi Albert Klinikai Kozpont, Borgyogyaszati es Allergologiai Klinika

location_facility: Clinica Dermatologica - Universita' di Catania

location_facility: Semmelweis Egyetem, Bor-, Nemikortani es Boronkologiai Klinika

location_facility: Centro di Ricerca Clinica Fondazione Universita' degli Studi Gabriele D'Annunzio

location_facility: Gulhane Askeri Tip Akademisi Tip Fakultesi

location_facility: Debreceni Egyetem Orvos-és Egészségtudományi Centrum

location_facility: Hospital General Universitario Alicante C/ Maestro Alonso, 1

location_facility: Bezm-i Alem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: Gulhane Military Medical Academy, Faculty of Medicine

location_facility: Klinik fuer Dermatologie, Allergologie und Venerologie

location_facility: J. W. Goethe Universitaet Frankfurt, Zentrum fuer Dermatologie und Venerologie

location_facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

location_facility: T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali

title: Randomized Open-label Study Comparing 2 Different Strategies For Management Of Subjects With Plaque Psoriasis Who Have Responded To Etanercept Treatment

location_country:
Germany
Italy
Hungary
United Kingdom
United Arab Emirates
Spain
Greece
Turkey
France


title: An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis

acronym: IRISS

summary: The IRISS study is designed to collect clinical and angiographic outcomes data when stenting intracranial atherosclerotic lesions using the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter in routine clinical practice.

ReferenceCitation: Sacco RL, Kargman DE, Gu Q, Zamanillo MC. Race-ethnicity and determinants of intracranial atherosclerotic cerebral infarction. The Northern Manhattan Stroke Study. Stroke. 1995 Jan;26(1):14-20. doi: 10.1161/01.str.26.1.14.

ReferenceCitation: EC/IC Bypass Study Group. Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. N Engl J Med. 1985 Nov 7;313(19):1191-200. doi: 10.1056/NEJM198511073131904.

ReferenceCitation: Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.

ReferenceCitation: Kasner SE, Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Benesch CG, Sila CA, Jovin TG, Romano JG, Cloft HJ; Warfarin Aspirin Symptomatic Intracranial Disease Trial Investigators. Predictors of ischemic stroke in the territory of a symptomatic intracranial arterial stenosis. Circulation. 2006 Jan 31;113(4):555-63. doi: 10.1161/CIRCULATIONAHA.105.578229. Epub 2006 Jan 23.

ReferenceCitation: Connors JJ 3rd, Wojak JC. Percutaneous transluminal angioplasty for intracranial atherosclerotic lesions: evolution of technique and short-term results. J Neurosurg. 1999 Sep;91(3):415-23. doi: 10.3171/jns.1999.91.3.0415.

ReferenceCitation: Marks MP, Wojak JC, Al-Ali F, Jayaraman M, Marcellus ML, Connors JJ, Do HM. Angioplasty for symptomatic intracranial stenosis: clinical outcome. Stroke. 2006 Apr;37(4):1016-20. doi: 10.1161/01.STR.0000206142.03677.c2. Epub 2006 Feb 23.

ReferenceCitation: SSYLVIA Study Investigators. Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries (SSYLVIA): study results. Stroke. 2004 Jun;35(6):1388-92. doi: 10.1161/01.STR.0000128708.86762.d6. Epub 2004 Apr 22.

ReferenceCitation: Wojak JC, Dunlap DC, Hargrave KR, DeAlvare LA, Culbertson HS, Connors JJ 3rd. Intracranial angioplasty and stenting: long-term results from a single center. AJNR Am J Neuroradiol. 2006 Oct;27(9):1882-92.

ReferenceCitation: Bose A, Hartmann M, Henkes H, Liu HM, Teng MM, Szikora I, Berlis A, Reul J, Yu SC, Forsting M, Lui M, Lim W, Sit SP. A novel, self-expanding, nitinol stent in medically refractory intracranial atherosclerotic stenoses: the Wingspan study. Stroke. 2007 May;38(5):1531-7. doi: 10.1161/STROKEAHA.106.477711. Epub 2007 Mar 29.

ReferenceCitation: Levy EI, Turk AS, Albuquerque FC, Niemann DB, Aagaard-Kienitz B, Pride L, Purdy P, Welch B, Woo H, Rasmussen PA, Hopkins LN, Masaryk TJ, McDougall CG, Fiorella DJ. Wingspan in-stent restenosis and thrombosis: incidence, clinical presentation, and management. Neurosurgery. 2007 Sep;61(3):644-50; discussion 650-1. doi: 10.1227/01.NEU.0000290914.24976.83.

ReferenceCitation: Zaidat OO, Klucznik R, Alexander MJ, Chaloupka J, Lutsep H, Barnwell S, Mawad M, Lane B, Lynn MJ, Chimowitz M; NIH Multi-center Wingspan Intracranial Stent Registry Study Group. The NIH registry on use of the Wingspan stent for symptomatic 70-99% intracranial arterial stenosis. Neurology. 2008 Apr 22;70(17):1518-24. doi: 10.1212/01.wnl.0000306308.08229.a3. Epub 2008 Jan 30.

ReferenceCitation: Fiorella D, Woo HH. Emerging endovascular therapies for symptomatic intracranial atherosclerotic disease. Stroke. 2007 Aug;38(8):2391-6. doi: 10.1161/STROKEAHA.107.482752. Epub 2007 Jun 21. No abstract available.

ReferenceCitation: Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Trial Investigators. Design, progress and challenges of a double-blind trial of warfarin versus aspirin for symptomatic intracranial arterial stenosis. Neuroepidemiology. 2003 Mar-Apr;22(2):106-17. doi: 10.1159/000068744. No abstract available.

ReferenceCitation: Samuels OB, Joseph GJ, Lynn MJ, Smith HA, Chimowitz MI. A standardized method for measuring intracranial arterial stenosis. AJNR Am J Neuroradiol. 2000 Apr;21(4):643-6.

lead_sponsor: Stryker Neurovascular

location_country: Germany France

location_facility:
CHU Toulouse
Universitätsklinikum Heidelberg
CHU Limoges
Universitätsklinikum Düsseldorf
Fondation Rotschild
Groupe Hospitalier Pellegrin
UKSH Campus Kiel
Hôpital Saint-Roch
Universitätsklinikum Erlangen
Universitätsklinikum Essen
CHU Hôpital Guillaume et René Laënnec
Asklepios Klinik Altona
CHU Dijon-Hopital General
CHU Reims
Klinikum Augsburg
Universitätsklinikum Dresden
Universitätsklinikum Freiburg
Höpital Gui de Chauliac
Hôpital Lariboisière


acronym: DECAPUB

lead_sponsor: Ipsen

summary: The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study.

location_facility:
Hôpital Archet II
Hôpital des Enfants
Hôpital de la Gespe
Medical Centre
American Memorial Hospital
Hôpital Flaubert
Hôpital Hôtel Dieu (CHU)
Hôpital Charles Nicolle
Hôpital Hautepierre
Hôpital Robert Debré

title: Follow-up of the Phase III, Multicentre, Non Comparative, One Single Group, Open Study to Assess the Long-term Efficacy and Tolerability of Pamoate of Triptorelin 11.25 mg in Children With Precocious Puberty


title: EXPRESSO - European Carto® XP REgistry for Validating Specialized CFAE SOftware

acronym: EXPRESSO

summary: The purpose of this prospective observational study (registry) is to determine the acute success rate of a complex fractionated atrial electrogram (CFAE) guided ablation procedure using a dedicated software and to determine the functionality and performance of the CFAE software in patients with a type of persistent atrial fibrillation (AF) in routine clinical practice.

lead_sponsor: Biosense Webster EMEA

location_country: Germany Hungary France

location_facility: Hôpital Privé Jacques Cartier Service de Rhytmologie

location_facility: Clinique Pasteur - Unité de Cardiologie interventionnelle

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: Hôpital Lariboisière Service de Rhytmologie

location_facility: Hôpital Les Franciscaines Service Rhythmologie


acronym: KinéSEP

summary: Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical ability of patients with and without FRP.

title: Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®


title: A Phase II Trial of Bevacizumab in Myelodysplastic Syndromes (Int-1, Int-2 and High Risk According to IPSS) With Excess of Marrow Blasts

summary:
The objectives of this phase II trial are to test the efficacy and tolerance of Bevacizumab in MDS patients with excess of marrow blasts and to evaluate the impact of Bevacizumab on angiogenesis and erythropoiesis.

To limit the myelotoxicity observed in the preliminary phase II study, Bevacizumab will be administrated at the initial dose of 5 mg/kg.

The primary endpoint will be response: Complete Remission (CR), Partial Remission (PR) and hematological improvement (HI) according to IWG criteria (see appendix 3).

The secondary endpoints will be survival, response duration, side effects, evaluation of angiogenesis (bone marrow microvessel density, VEGF plasma level, VEGF mRNA expression, HIF-1alpha expression).

The design of this study consists of three study periods: pre-treatment (screening), treatment (loading and maintenance), and follow-up. All patients will participate in the study for at least 12 weeks of therapy, a 4-week follow-up visit, and long-term follow-up unless the criteria for planned or unplanned early discontinuation are met.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Department of Clinical hematology, Archet Hospital, CHU de Nice

location_facility: Department of clinical hematology, Robert Debré Hospital

location_facility: Department of Hematology and Oncology, CHU de Strasbourg

location_facility: Department of Onco-Hematology, Caremeau Hospital, CHU Nîmes


title: Randomized Therapeutic Study of a Treatment by Tacrolimus Adapted or Not According to the Genotype of the Cytochrome P450 3A5 After Renal Transplantation

summary:
Renal transplantation is the treatment of choice of the chronic renal insufficiency arrived at its final stage. Tacrolimus is an immunosuppressant treatment used for the prevention of episodes of acute rejection. Tacrolimus is characterized by a narrow therapeutic index and important interindividual variations of its pharmacokinetic characteristics. Proteins CYP3A4 and CYP3A5 are responsible of intestinal and hepatic metabolism of Tacrolimus. Various polymorphisms for CYP3A5 and CYP3A4 were described and several retrospective studies suggested an association between a genetic polymorphism of CYP3A5 and the pharmacokinetic parameters of Tacrolimus. In particular, we showed that the presence of an allele CYP3A5*1 was associated to the use of more important amounts of Tacrolimus to obtain the desired blood concentrations.

This study is a national, multicentric, prospective, opened, randomized on two arms of treatment. 280 receivers of a renal transplant in 12 centres will be included. The genotyping of gene CYP3A5 will be carried out in the 6 days following transplantation. During the first week, the patients will be treated by basiliximab, MMF and corticosteroids. They will be randomized (central randomization) in D6 to receive either Tacrolimus at 0.2 mg/kg/d, or at a dosage adapted to their genotype. After determination of the first residual blood concentration of Tacrolimus realized after six oral intakes, the daily amounts of Tacrolimus could be modified if necessary to reach the desired blood concentrations. The total duration of the study for a patient is 3 months after transplantation.

The objective of this study is to evaluate the impact of the adaptation, according to the genotype of the CYP3A5 of the patient, of the first amount of Tacrolimus on the first residual blood concentration of Tacrolimus, keeping in mind the aim of the individualization of dosage schedule by pharmacogenetic approach.

Principal criterion : Comparison, between the two groups, of the percentage of patients for whom the first blood concentration of Tacrolimus evaluated 3 days (D10) after the first administration of Tacrolimus ranges between 10 and 15 ng/ml.

Statistics will be carried out in intention to treat. The principal criterion will be analyzed by the test of chi-2.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

collaborators:
Roche Pharma AG
Astellas Pharma Inc

location_facility:
CHU Rennes - Hôpital Pontchaillou
CHU Strasbourg - Hospices Civils
CHU de la côté de Nacre
CHU Gabriel Montpied
CHU Reims - Hôpital Maison Blanche
CHU Poitiers- hôpital Jean Bernard
CHU Limoges - Hôpital Dupuytren
CHU Tours - Hôpital Bretonneau
CHU Rouen - Hôpital de Bois-Guillaume
CHU Angers


acronym: RACCER

lead_sponsor: UNICANCER

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and cetuximab after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II clinical trial is studying how well giving radiation therapy together with chemotherapy and cetuximab followed by surgery, chemotherapy, and cetuximab works in treating patients with locally advanced or metastatic rectal cancer that can be removed by surgery.

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

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

title: Phase II Multicenter Study of the Impact of the Therapeutic Sequence of Radiochemotherapy (50 Gy + Capecitabine + Oxaliplatin + Cetuximab) Followed by Total Mesorectal Excision Surgery Then Post-surgery Chemotherapy (FOLFOX 4 + Cetuximab) in Synchronous Locally Advanced or Metastatic Cancers of the Rectum With Metastases Resectable From the Start (T3-4 Nx or T2 N+ M1).


title: Study of the Effects of High Frequency Stimulation of the Subthalamic Stimulation in the Treatment of Severe Obsessive-compulsive Disorders

summary: Obsessive-compulsive disorder is a disabling and frequent disorder. In some patients, the medical treatment is ineffective. The pathophysiology of this disease is still unknown. Some data suggest that basal ganglia dysfunction could participate in the occurrence of OCD. The aim of this study is to evaluate the efficacy of subthalamic nucleus high-frequency stimulation in patients with severe OCD.

ReferenceCitation: Le Jeune F, Verin M, N'Diaye K, Drapier D, Leray E, Du Montcel ST, Baup N, Pelissolo A, Polosan M, Mallet L, Yelnik J, Devaux B, Fontaine D, Chereau I, Bourguignon A, Peron J, Sauleau P, Raoul S, Garin E, Krebs MO, Jaafari N, Millet B; French Stimulation dans le trouble obsessionnel compulsif (STOC) study group. Decrease of prefrontal metabolism after subthalamic stimulation in obsessive-compulsive disorder: a positron emission tomography study. Biol Psychiatry. 2010 Dec 1;68(11):1016-22. doi: 10.1016/j.biopsych.2010.06.033. Epub 2010 Oct 16.

ReferenceCitation: Bourredjem A, Pelissolo A, Rotge JY, Jaafari N, Machefaux S, Quentin S, Bui E, Bruno N, Pochon JB, Polosan M, Baup N, Papetti F, Chereau I, Arbus C, Mallet L, du Montcel ST; French "Stimulation dans le Trouble Obsessionnel Compulsif (STOC)" Study Group. A video Clinical Global Impression (CGI) in obsessive compulsive disorder. Psychiatry Res. 2011 Mar 30;186(1):117-22. doi: 10.1016/j.psychres.2010.06.021. Epub 2011 Feb 12.

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

lead_sponsor: Marie-laure Welter

sponsor_collaborators:
Marie-laure Welter
Assistance Publique - Hôpitaux de Paris

location_facility: Centre d'Investigation Clinique-Hôpital Pitié-Salpêtrière


title: Phase 3 Study of Oral Dehydroepiandrosterone (DHEA) in Adults With Myotonic Dystrophy

summary: To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with myotonic dystrophy

ReferenceCitation: Penisson-Besnier I, Devillers M, Porcher R, Orlikowski D, Doppler V, Desnuelle C, Ferrer X, Bes MC, Bouhour F, Tranchant C, Lagrange E, Vershueren A, Uzenot D, Cintas P, Sole G, Hogrel JY, Laforet P, Vial C, Vila AL, Sacconi S, Pouget J, Eymard B, Chevret S, Annane D. Dehydroepiandrosterone for myotonic dystrophy type 1. Neurology. 2008 Aug 5;71(6):407-12. doi: 10.1212/01.wnl.0000324257.35759.40.

lead_sponsor: University of Versailles

collaborators: Association Française contre les Myopathies (AFM), Paris

location_facility:
Institut de myologie
CHU
CHU Pouget
Raymond Poincaré Hospital


title: Randomized Phase II Trial Evaluating [Radiotherapy-Docetaxel-5 Fluorouracil] Association Versus [Radiotherapy-Docetaxel-Cisplatin] Association in Non Resecables First Line of Chemotherapy in Metastatics Pancreas Cancers Patients

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy, docetaxel, and fluorouracil are more effective than radiation therapy, docetaxel, and cisplatin as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy, docetaxel, and fluorouracil to see how well they work as first-line therapy compared to radiation therapy, docetaxel, and cisplatin in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

ReferenceCitation: Oberic L, Viret F, Baey C, Ychou M, Bennouna J, Adenis A, Peiffert D, Mornex F, Pignon JP, Celier P, Berille J, Ducreux M. Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer: a FNCLCC-ACCORD/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival. Radiat Oncol. 2011 Sep 26;6:124. doi: 10.1186/1748-717X-6-124.

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


title: Radio-Surgical Treatment of Breast Cancer of Women Aged Over 70: Phase II Trial of Feasibility and Reproducibility of a Concentrated and Focalized Radiotherapy

summary:
RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for stage I or stage II breast cancer.

location_facility:
Institut Bergonie
Hopital Saint-Louis
Centre Antoine Lacassagne
CHU Pitie-Salpetriere
Centre Leon Berard
Institut Gustave Roussy
Centre Oscar Lambret
Centre Paul Strauss
Centre Hospitalier Lyon Sud
Centre Alexis Vautrin


title: First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne/Mer


title: Assessment of HGI (Hemoglobin Glycation Index) Variability Over Time in Patients Living With Diabetes Using Continuous Glucose Monitoring

acronym: GAP OUEST

summary: The goal of this clinical trial is to learn about the variability of HGI (Hemoglobin Glycation Index) over time in patients living with diabetes using a continuous glucose monitoring.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Nantes University Hospital

location_facility:
CH de La Rochelle
CHU de Caen
CHU de Poitiers
CHU de Toulouse
CH du Mans
CHU de Brest
CHU d'Angers
CHU de Rennes
CHU de Nantes


title: Phase III Randomized, Multicenter Open Label Study to Evaluate the Efficacy of Immunomodulatory Therapy in Case of Psychiatric Disorders With Proven Dysimmunity.

acronym: TIM-DePisT

summary: This is an open phase III randomized clinical trial studying the superiority of management by immunomodulator treatment of psychiatric disorders (psychosis and bipolar disorders) for patients previously identified as carriers of autoimmunity such as as the presence of a pathogenic anti-glutamatergic NMDA receptor antibody (NMDAr-Ac).

lead_sponsor: University Hospital, Bordeaux

location_facility:
APHP Kremlin Bicetre
Centre Hospitalier Charles Perrens
APHP Louis Mourier
CHU de Clermond Ferrand
CHU de Strasbourg
Centre hospitalier le Vinatier
CHU de Montpellier
APHP Henri Mondor
CHU de Bordeaux


title: "French National Cohort of Patients With Pediatric-onset of Autoimmune Cytopenia (OBS'CEREVANCE Cohort)"

acronym: OBS'CEREVANCE

summary: From 2004, OBS'CEREVANCE is a national real-world prospective clinical cohort of patients with auto-immune cytopenia of pediatric-onset : Immune thrombocytopenia (ITP), Autoimmune Hemolytic anemia (AIHA), or Evans syndrome (all bi or tri cytopenias). Thanks to the collaboration of the 30 French pediatric hematologic centers, this cohort supports all of the Rare Disease Centre CEREVANCE (Centre de Référence National des Cytopénies Auto-Immunes de l'Enfant) missions for care, education and research. Specifically, this original unbiased database allows to describe the long-term health of adult patients, to identify the heterogenous genetic underlying pathophysiologic contexts, and to study the benefit-risk balance of treatments, including the growing development of targeted therapies.

ReferenceCitation: Ducassou S, Leverger G, Fernandes H, Chambost H, Bertrand Y, Armari-Alla C, Nelken B, Monpoux F, Guitton C, Leblanc T, Fisher A, Lejars O, Jeziorski E, Fouissac F, Lutz P, Pasquet M, Pellier I, Piguet C, Vic P, Bayart S, Marie-Cardine A, Michel M, Perel Y, Aladjidi N. Benefits of rituximab as a second-line treatment for autoimmune haemolytic anaemia in children: a prospective French cohort study. Br J Haematol. 2017 Jun;177(5):751-758. doi: 10.1111/bjh.14627. Epub 2017 Apr 26.

ReferenceCitation: Aladjidi N, Jutand MA, Beaubois C, Fernandes H, Jeanpetit J, Coureau G, Gilleron V, Kostrzewa A, Lauroua P, Jeanne M, Thiebaut R, Leblanc T, Leverger G, Perel Y. Reliable assessment of the incidence of childhood autoimmune hemolytic anemia. Pediatr Blood Cancer. 2017 Dec;64(12). doi: 10.1002/pbc.26683. Epub 2017 Jul 27.

ReferenceCitation: Penel Page M, Bertrand Y, Fernandes H, Kherfellah D, Leverger G, Leblanc T, Libbrecht C, Michel G, Jeziorski E, Armari-Alla C, Nelken B, Pellier I, Pasquet M, Perel Y, Aladjidi N. Treatment with cyclosporin in auto-immune cytopenias in children: The experience from the French cohort OBS'CEREVANCE. Am J Hematol. 2018 May 14. doi: 10.1002/ajh.25137. Online ahead of print. No abstract available.

ReferenceCitation: Pincez T, Neven B, Le Pointe HD, Varlet P, Fernandes H, Gareton A, Leverger G, Leblanc T, Chambost H, Michel G, Pasquet M, Millot F, Hermine O, Mathian A, Hully M, Zephir H, Hamidou M, Durand JM, Perel Y, Landman-Parker J, Rieux-Laucat F, Aladjidi N. Neurological Involvement in Childhood Evans Syndrome. J Clin Immunol. 2019 Feb;39(2):171-181. doi: 10.1007/s10875-019-0594-3. Epub 2019 Jan 22.

ReferenceCitation: Hadjadj J, Aladjidi N, Fernandes H, Leverger G, Magerus-Chatinet A, Mazerolles F, Stolzenberg MC, Jacques S, Picard C, Rosain J, Fourrage C, Hanein S, Zarhrate M, Pasquet M, Abou Chahla W, Barlogis V, Bertrand Y, Pellier I, Colomb Bottollier E, Fouyssac F, Blouin P, Thomas C, Cheikh N, Dore E, Pondarre C, Plantaz D, Jeziorski E, Millot F, Garcelon N, Ducassou S, Perel Y, Leblanc T, Neven B, Fischer A, Rieux-Laucat F; members of the French Reference Center for Pediatric Autoimmune Cytopenia (CEREVANCE). Pediatric Evans syndrome is associated with a high frequency of potentially damaging variants in immune genes. Blood. 2019 Jul 4;134(1):9-21. doi: 10.1182/blood-2018-11-887141. Epub 2019 Apr 2.

ReferenceCitation: Margot H, Boursier G, Duflos C, Sanchez E, Amiel J, Andrau JC, Arpin S, Brischoux-Boucher E, Boute O, Burglen L, Caille C, Capri Y, Collignon P, Conrad S, Cormier-Daire V, Delplancq G, Dieterich K, Dollfus H, Fradin M, Faivre L, Fernandes H, Francannet C, Gatinois V, Gerard M, Goldenberg A, Ghoumid J, Grotto S, Guerrot AM, Guichet A, Isidor B, Jacquemont ML, Julia S, Khau Van Kien P, Legendre M, Le Quan Sang KH, Leheup B, Lyonnet S, Magry V, Manouvrier S, Martin D, Morel G, Munnich A, Naudion S, Odent S, Perrin L, Petit F, Philip N, Rio M, Robbe J, Rossi M, Sarrazin E, Toutain A, Van Gils J, Vera G, Verloes A, Weber S, Whalen S, Sanlaville D, Lacombe D, Aladjidi N, Genevieve D. Immunopathological manifestations in Kabuki syndrome: a registry study of 177 individuals. Genet Med. 2020 Jan;22(1):181-188. doi: 10.1038/s41436-019-0623-x. Epub 2019 Jul 31.

ReferenceCitation: Ducassou S, Gourdonneau A, Fernandes H, Leverger G, Pasquet M, Fouyssac F, Bayart S, Bertrand Y, Michel G, Jeziorski E, Thomas C, Abouchallah W, Viard F, Guitton C, Cheikh N, Pellier I, Carausu L, Droz C, Leblanc T, Aladjidi N; Centre de Reference National des Cytopenies Auto-immunes de l'Enfant (CEREVANCE). Second-line treatment trends and long-term outcomes of 392 children with chronic immune thrombocytopenic purpura: the French experience over the past 25 years. Br J Haematol. 2020 Jun;189(5):931-942. doi: 10.1111/bjh.16448. Epub 2020 Mar 4.

ReferenceCitation: Ducassou S, Fernandes H, Savel H, Bertrand Y, Leblanc T, Abou Chahla W, Pasquet M, Leverger G, Barlogis V, Thomas C, Bayart S, Pellier I, Armari-Alla C, Guitton C, Cheikh N, Kherfellah D, Vassal G, Thiebaut R, Laghouati S, Aladjidi N. Prospective Evaluation of the First Option, Second-Line Therapy in Childhood Chronic Immune Thrombocytopenia: Splenectomy or Immunomodulation. J Pediatr. 2021 Apr;231:223-230. doi: 10.1016/j.jpeds.2020.12.018. Epub 2020 Dec 17.

ReferenceCitation: Pincez T, Fernandes H, Leblanc T, Michel G, Barlogis V, Bertrand Y, Neven B, Chahla WA, Pasquet M, Guitton C, Marie-Cardine A, Pellier I, Armari-Alla C, Benadiba J, Blouin P, Jeziorski E, Millot F, Paillard C, Thomas C, Cheikh N, Bayart S, Fouyssac F, Piguet C, Deparis M, Briandet C, Dore E, Picard C, Rieux-Laucat F, Landman-Parker J, Leverger G, Aladjidi N. Long term follow-up of pediatric-onset Evans syndrome: broad immunopathological manifestations and high treatment burden. Haematologica. 2022 Feb 1;107(2):457-466. doi: 10.3324/haematol.2020.271106.

ReferenceCitation: Pincez T, Aladjidi N, Heritier S, Garnier N, Fahd M, Abou Chahla W, Fernandes H, Dichamp C, Ducassou S, Pasquet M, Bayart S, Moshous D, Cheikh N, Paillard C, Plantaz D, Jeziorski E, Thomas C, Guitton C, Deparis M, Marie Cardine A, Stephan JL, Pellier I, Dore E, Benadiba J, Pluchart C, Briandet C, Barlogis V, Leverger G, Leblanc T. Determinants of long-term outcomes of splenectomy in pediatric autoimmune cytopenias. Blood. 2022 Jul 21;140(3):253-261. doi: 10.1182/blood.2022015508.

ReferenceCitation: Pincez T, Fernandes H, Pasquet M, Abou Chahla W, Granel J, Heritier S, Fahd M, Ducassou S, Thomas C, Garnier N, Barlogis V, Jeziorski E, Bayart S, Chastagner P, Cheikh N, Guitton C, Paillard C, Lejeune J, Millot F, Li-Thiao Te V, Mallebranche C, Pellier I, Neven B, Armari-Alla C, Carausu L, Piguet C, Benadiba J, Pluchart C, Stephan JL, Deparis M, Briandet C, Dore E, Marie-Cardine A, Leblanc T, Leverger G, Aladjidi N. Impact of age at diagnosis, sex, and immunopathological manifestations in 886 patients with pediatric chronic immune thrombocytopenia. Am J Hematol. 2023 Jun;98(6):857-868. doi: 10.1002/ajh.26900. Epub 2023 Mar 21.

location_facility: CHU de Bordeaux - Unité d'Hématologie et d'Oncologie pédiatrique

location_facility: BESANCON CHU de Besançon Hôpital Jean MINJOZ Unité d'Hémato-Oncologie Pédiatrique, Pédiatrie 1

location_facility: CHU d'Angers Unité d'Hémato-Oncologie Pédiatrique

location_facility: APHP Hôpital Bicêtre Service de Pédiatrie générale

location_facility: CHU Amiens Picardie Service d' Onco-Immuno-Hématologie Pédiatrique

location_facility: CHU BREST Hôpital Morvan Unité d'Onco-Hématologie