title: Cost-utility Evaluation of Two Strategies of Perineal Reconstruction After Abdominoperineal Resection for Anorectal Carcinoma: Perineal Filling With Biological Meshes vs. Primary Perineal Wound Closure

summary: Abdominoperineal resection performed for anorectal tumors leaves a large pelvic and perineal defect causing a high rate of morbidity of the perineal wound (40 - 60 %). Biological meshes offer possibility for a new standard of perineal wound reconstruction. Perineal filling with biological mesh is expected to increase quality of life by reducing perineal morbidity.

ReferenceCitation: Buscail E, Canivet C, Ghouti L, Kirzin S, Carrere N, Molinier L, Rosillo A, Lauwers-Cances V, Costa N; French Research Group of Rectal Cancer Surgery (GRECCAR Group). Randomised clinical trial for the cost-utility evaluation of two strategies of perineal reconstruction after abdominoperineal resection in the context of anorectal carcinoma: biological mesh repair versus primary perineal wound closure, study protocol for the GRECCAR 9 Study. BMJ Open. 2021 Apr 1;11(4):e043333. doi: 10.1136/bmjopen-2020-043333.

lead_sponsor: University Hospital, Toulouse

location_facility:
Amiens University Hospital
Saint-Antoine Hospital
Institut de Cancérologie de Lorraine
Paoli Calmettes Institut
Besançon University Hospital
Centre Oscar Lambret
University Hospital of Toulouse
Nancy University Hospital
Angers University Hospital
Clermont-Ferrand University Hospital
Bordeaux University Hospital
Lyon University Hospital
Caen University Hospital
Grenoble University Hospital
CHRU Lille
Rouen University Hospital
Nantes University Hospital


title: " Endarterectomy Combined With Optimal Medical Therapy Versus Optimal Medical Therapy Alone in Patients With Asymptomatic Severe Atherosclerotic Carotid Artery Stenosis at Higher-than-average Risk of Ipsilateral Stroke "

acronym: ACTRIS

summary: The purpose of this study is to determine whether carotid surgery combined with optimal medical therapy improves long-term survival free of ipsilateral stroke in patients with asymptomatic carotid stenosis at higher-than-average risk of ipsilateral stroke when compared with optimal medical therapy alone.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Centre Hospitalier St Anne

location_facility: CHU de Toulouse Hôpital Pierre-Paul Riquet

location_facility: Centre Hospitalier régional de Besançon, Hôpital Jean Minjoz

location_facility: Hôpital Neurologique Pierre Wertheimer GHE

location_facility: Centre Hospitalier Bichat-Claude Bernard

location_facility: CHU de Strasbourg, Hôpital de Hautpierre

location_facility: CHU Bordeaux, Groupe Hospitalier Pellegrin

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Observational Multicenter Cohort Study of French Patients With a Central or Combined Syndrome of Sleep Apnea With a Predominant Central SAS Treated by Adaptive Servo-Ventilation

acronym: FACIL-VAA

summary: The main goal of this French multicenter observational cohort study is to prospectively collect data assessing the impact of the Adaptative Servo-Ventilation treatment on the quality of sleep of patients with central or combined sleep apnea syndrome (SAS) out of Heart Failure (HF) with altered ejection fraction, with a predominant central SAS.

study_start_date_type: Actual

status: Unknown status

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: oversight committee

lead_sponsor: Société Française de Recherche et de Médecine du Sommeil

location_facility: Hôpital Arnaud de Villeneuve CHU de Montpellier

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

location_facility: Centre Hospitalier Intercommunal Compiègne-Noyon

location_facility: Groupe Hospitalier Public du Sud de l'Oise

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Unknown


title: NADIR: Multicentre, Open-Label Trial Evaluating a Simple NeoRecormon Regimen in Anemic Patients With Diabetes and Chronic Kidney Disease (Stage 2 to 5) Who Are Not on Dialysis

summary: This study will evaluate the effect of epoetin beta (NeoRecormon) on correction of anemia and quality of life in participants with diabetes and chronic renal failure and who are not receiving dialysis.

status: Completed

study_completion_date_type: Actual

primary_purpose: Treatment

lead_sponsor: Hoffmann-La Roche

intervention_type: Drug

status_simplified: Completed


title: Assessment of the Clinic-pathological Correlation of Basal Cell Carcinoma: Establishment of a Prospective Observational Cohort and Followed 3 Years

acronym: CAC-CBC

summary: Assessment of the concordance of the initial clinical and histological diagnosis and to explore its prognostic impact in terms of risk of recurrence.

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility: Tranchand (Dermatologue - Le Puy En Velay)

location_facility: University Hospital of Bordeaux - Hospital Saint André

location_facility: Groupe Hospitalier de L'Institut Catholique de Lille


status: Active, not recruiting

acronym: BEVANEC

title: Assessment of the Efficacy of Bevacizumab in Combination With Folfiri as Second-line Treatment After the Failure of the Cisplatin (or Carboplatin)-Etoposide Combination in Patients Suffering From an Advanced Inoperable Poorly Differentiated Neuroendocrine Carcinoma of an Unknown or Gastroentero-pancreatic Primary Cancer. A Phase 2 Non-comparative Randomized Study

lead_sponsor: Hospices Civils de Lyon

type: EudraCT Number

source: euctr

location_facility: Service d'Hépato-Gastroenterologie et Oncologie Digestive, Hôpital Européen Georges Pompidou, APHP

location_facility: Service de Gastroentérologie et Pancréatologie, Hôpital Beaujon, APHP

location_facility: Service d'Oncologie Médicale, Hôpital Saint Eloi, CHU de Montpellier

location_facility: Service de Gastro-Entérologie, Hôpital Nord, CHU de ST-Etienne

location_facility: Service d'Hépatogastroentéologie, Hôpital Michallon, CHU de Grenoble

location_facility: Service d'Oncologie Médicale, Hôpital Civil, CHU de Strasbourg

location_facility: Service de Gastroentérologie, CHU Henri Mondor

location_facility: Service d'Hépato-Gastroentérologie et Oncologie Digestive, CHU de Dijon

location_facility: Service d'Hépato-Gastroenterologie et Oncologie Digestive, Hôpital Sud, CHU d'Amiens

location_facility: Département d'Oncologie Médicale, Institut Paoli Calmettes

location_facility: Service d'Hépatogastroentérologie, CHR d'Orléans

location_facility: Département d'Oncologie Médicale, Hôpital Saint-Antoine

location_facility: Service d'Hépato-Gastroentérologie et d'Oncologie Digestive, Hôpital Haut Lévêque, CHU Bordeaux

location_facility: Service d'Oncologie et Radiothérapie, Institut Sainte Catherine

location_facility: Service d'Oncologie Endocrinienne, Institut Gustave Roussy

location_facility: Service de Gastroentérologie et Oncologie Digestive, Hôpital Avicenne

location_facility: Pôle Régional de Cancérologie, CHU de Poitiers

location_facility: Service d'Hépatogastroentérologie, Hôpital Pontchaillou, CHU de Rennes

location_facility: Service d'Hépatogastroentérologie, CHU d'Angers

location_facility: Département de cancérologie médicale - Groupe des tumeurs endocrines, Centre Léon Bérard

location_facility: Service de Gastroentérologie, CHU de Rouen

location_facility: Service d'Hépato-Gastroentérologie et Cancérologie, Hôpital Robert Debré, CHU de Reims

location_facility: Service de Gastroentérologie, Hôpital Cochin, APHP

location_facility: Service d'Oncologie Médicale - Hôpital Edouard Herriot - Hospices Civils de Lyon

location_facility: Service d'Hépato-Gastroentérologie et d'Oncologie Digestive, Hôpital de la Timone, APHM

location_facility: Département de Cancérologie Urologique et Digestive, Centre Oscar Lambret

summary:
Poorly differentiated neuroendocrine carcinomas (NEC) are a sub-group of aggressive neuroendocrine neoplasms (NEN). The most common primary sites are broncho-pulmonary and digestive. The gastroentero-pancreatic NECs (GEP-NEC) represent 7-21% of all of the NENs.

Recent data on the initial presentation of GEP-NEC have been reported in two retrospective studies and a French cohort study. No standard second-line treatment has been defined for NECs. Despite a very negative prognosis, these NECs have a certain amount of chemosensitivity, close to that of bronchial NECs. Multiple-drug therapies such as Folfiri, or Folfox, or single drug treatments such as temozolomide are the proposed options but with a low level of proof Bevacizumab associated with a cytotoxic chemotherapy has shown promising results in well differentiated neuroendocrine tumors (NET), known for being hypervascular. The efficacy of bevacizumab has also been suggested in patients with NEC, but never in the context of a phase II study. Its combination with Folfiri is efficient and well tolerated in metastatic colorectal cancer. The combination Folfiri-bevacizumab potentially represents an optimized treatment compared to chemotherapy with only Folfiri. No phase II or III studies have reported results for these patients, and no on-going phase II or III trial have been identified to date.

The main objective of this study is to show that, after the failure of a first-line chemotherapy using platinum-etoposide, the combination Folfiri-bevacizumab allows significant prolongation of overall survival in adult patients with GEP-NEC.


title: Intensified Methotrexate, Vinblastine, Doxorubicin and Cisplatin +/-Panitumumab as First-line Treatment of Advanced Urothelial Carcinoma in Patients Without Harvey Nor Kirsten Rat Sarcoma Viral Oncogene Homolog Mutations. Phase II Study

lead_sponsor: UNICANCER

location_facility:
Centre Alexis Vautrin
Institut Claudius Regaud
Institut Bergonie
Hopital Henri Mondor
Centre Hospitalier Lyon Sud
Institut Paoli Calmettes
Hopitaux Universitaires
Pitie Salpetriere
Centre Francois Baclesse
Chu de Nimes
Diaconesses - Croix St Simon
Institut Gustave Roussy
Institut Cancerologie de La Loire
Centre Leon Berard
Institut Curie
Hopital Saint Andre
Centre Rene Gauducheau

summary:
OBJECTIVES OF THE TRIAL

Primary objective

Evaluation of efficacy in terms of progression-free survival at 9 months of the combination of intensified methotrexate, vinblastine, doxorubicin and cisplatin with or without panitumumab as first-line treatment of advanced urothelial carcinoma in patients without Harvey nor Kirsten rat sarcoma viral oncogene homolog mutations.

Secondary objectives

To assess toxicity
To assess response rate
To assess overall survival
To assess time to progression
To study the correlation between response rate, time to progression, overall survival and biological parameters


title: Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment

acronym: ADNCirc

summary:
Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses is based on surgical resection, when possible, chemotherapy and targeted therapies. To detect recurrences or metastases, a surveillance strategy is recommended for patients able to withstand complementary treatment during a five-year period. Over this period, the probability of one false-positive result is 87%. Considering that less than 10% of recurrent patients are suitable for potentially curative treatment and that more intensive programs enable an increase of the overall rate of curative resection but do not result in reduced mortality, less time and cost-consuming, tailored follow-up is necessary. The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance.

Tubes for ccfDNA analysis will be taken during medical examination at the same time of the CEA dosage (if it was not made before the consultation). Cryotubes of plasma will be sent for analysis in the laboratory INSERM (National Health Institute) of Montpellier and the remaining plasma will be kept in biological collection.

Patients will have a consultation of follow-up every 3-4 months during which the dosage of CEA and ccfDNA will be realized as well as a medical examination, a general examination (weight, size, and blood pressure), an evaluation of the indices of performance status and a nutritional evaluation in case of loss of weight.

primary_purpose: Diagnostic

ipd_sharing_description: the data are anonymized

lead_sponsor: University Hospital, Limoges

location_facility:
Montpellier University Hospital
Gueret Hospital
Sainte feyre Hospital
Saint Antoine AP-HP
Cahors Hospital
Moulins Hospital
Bergonie institute
Brive Hospital
Aurillac Hospital
Montpellier Institute
Clermont Ferrand University Hospital
Vichy Hospital
La marche clinical
Perigueux clinical
Les Cèdres clinical
Bordeaux University Hospital
Périgueux Hospital
Saint Junien Hospital
Limoges Hospital

intervention_type: Genetic


title: Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections: EVALYMPH Study

acronym: EVALYMPH

summary: Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis. The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Centre de Lutte contre le Cancer, TOULOUSE

location_facility: Hôpital La pitié-Salpetrière CHU PARIS 3

location_facility: Hôpital Saint Louis-Lariboisière CHU PARIS 5


title: Candidate Therapies in Combination or Sequentially With Tyrosine Kinase Inhibitors in Chronic Phase-chronic Myelogenous Leukemia Patients in CCR Without Achieving a Deep Molecular Response: an Adaptative Trial Based on a Drop Loser Design

acronym: ACTIW

summary:
Patients will be randomized in phase II trials to continue on the same TKI versus one of the alternative treatment approaches. If a patient is not eligible for one of the treatments, he (she) will be randomized between the options for which he (she) is eligible.

The trial will start with current available treatment options (experimental arms). New available treatment options may be open at any times later on. Authorized TKIs are imatinib, nilotinib, dasatinib, bosutinib and ponatinib.

For all options the treatment duration is for a minimum of 12 months and will be continued in the absence of adverse events following investigator decision. Each therapeutic option will be detailed in term of combination modalities, dose, dose adaptation, specific warnings, specific exclusion and inclusion criteria. The decision to introduce a new option will depend on the general pace of recruitment and on the assessment of the potential efficacy and safety of the new treatment, and will be implemented after scientific review by a protocol amendment.

Primary objective:

A. To select molecules in combination or sequentially with imatinib, nilotinib, dasatinib, bosutinib or ponatinib potentially able to produce a 25% increase in the Cumulative Incidence of MR4.5 as compare to control.

Secondary objectives:

A. To determine the safety of selected therapies

B. To determine the rate of MR4 by 12, 24, 36, 48 months in experimental and control arms

C. To determine the rates of MR4.5 by 24, 36, 48 months in experimental and control arms

D. To determine the rate of undetectable BCR-ABL1 transcript (sensitivity 40000 ABL copies) by 12, 24, 36, 48 months in experimental and control arms

E. To estimate treatment free remission (TFR) in patients eligible for discontinuation studies

F. To investigate the relationship between biological activity and the clinical efficacy of the selected therapies

G. To assess the effects of the treatments on the number and clonogenicity of CML stem cells and other biological markers of interest

H. To estimate duration of response, progression-free survival, event free survival and overall survival.

status: Recruiting

lead_sponsor: Versailles Hospital

location_facility:
Hopital l'Archet
CHU Lille
Thorsten BRAUN
Cayssials
CHU Côte de Nacre
CH Henri Mondor
Viviane DUBRUILLE
Martine GARDEMBAS
Hôpital René Huguenin
CHU Tours
Etienne
CHU de Rennes - Pontchaillou
Eric JOURDAN
Institut Universitaire contre le Cancer
Institut P Calmette
Rousselot
Simona LAPUSAN_St Antoine
CHU de LIMOGES
Delphine REA _St louis
CHU Estaing
Franck NICOLINI
Pascale CONY.MAKHOUL
Hôpital La Source


title: Impact of Early Optimization of Brain Oxygenation on Neurological Outcome After Severe Traumatic Brain Injury

acronym: OXY-TC

summary:
Post-traumatic brain hypoxia/ischemia develops hours after traumatic brain injury (TBI), and its intensity is directly related to the neurological outcome. The thresholds for irreversible tissue damage following TBI indicate a particular vulnerability of injured brain. Improving brain oxygenation after severe TBI is the focus of modern TBI management in the intensive care unit (ICU).

The calculation of cerebral perfusion pressure (CPP), with CPP = mean arterial pressure (MAP) - intracranial pressure (ICP), has become the most used estimator of cerebral blow flow. To prevent ischemia due to elevated ICP, current international guidelines recommend maintaining CPP at 60-70 mmHg and ICP below 20 mmHg. However, episodes of brain hypoxia/ischemia, as assessed with brain tissue oxygen pressure (PbtO2) measurements, might occur despite optimization of CPP and ICP, and have been independently associated with poorer patient outcome. PbtO2 values lower than 15 mmHg for more than 30 minutes were shown to be an independent predictor of unfavorable outcome and death. The aggressive treatment of low PbtO2 was associated with improved outcome compared to standard ICP/CPP-directed therapy in cohort studies of severely head-injured patients. On the basis of these findings, it is hypothesized that an early optimization of brain oxygenation, together with keeping ICP and CPP within recommended values, could reduce the volume of vulnerable lesions following severe TBI and possibly improve neurological outcome.

ReferenceType: background

ReferenceCitation: Cunningham AS, Salvador R, Coles JP, Chatfield DA, Bradley PG, Johnston AJ, Steiner LA, Fryer TD, Aigbirhio FI, Smielewski P, Williams GB, Carpenter TA, Gillard JH, Pickard JD, Menon DK. Physiological thresholds for irreversible tissue damage in contusional regions following traumatic brain injury. Brain. 2005 Aug;128(Pt 8):1931-42. Epub 2005 May 11.

ReferenceCitation: Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS, Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. IX. Cerebral perfusion thresholds. J Neurotrauma. 2007;24 Suppl 1:S59-64. Erratum in: J Neurotrauma. 2008 Mar;25(3):276-8. multiple author names added.

ReferenceCitation: Oddo M, Levine JM, Mackenzie L, Frangos S, Feihl F, Kasner SE, Katsnelson M, Pukenas B, Macmurtrie E, Maloney-Wilensky E, Kofke WA, LeRoux PD. Brain hypoxia is associated with short-term outcome after severe traumatic brain injury independently of intracranial hypertension and low cerebral perfusion pressure. Neurosurgery. 2011 Nov;69(5):1037-45; discussion 1045. doi: 10.1227/NEU.0b013e3182287ca7.

ReferenceCitation: van den Brink WA, van Santbrink H, Steyerberg EW, Avezaat CJ, Suazo JA, Hogesteeger C, Jansen WJ, Kloos LM, Vermeulen J, Maas AI. Brain oxygen tension in severe head injury. Neurosurgery. 2000 Apr;46(4):868-76; discussion 876-8.

ReferenceCitation: Stiefel MF, Spiotta A, Gracias VH, Garuffe AM, Guillamondegui O, Maloney-Wilensky E, Bloom S, Grady MS, LeRoux PD. Reduced mortality rate in patients with severe traumatic brain injury treated with brain tissue oxygen monitoring. J Neurosurg. 2005 Nov;103(5):805-11.

ReferenceCitation: Narotam PK, Morrison JF, Nathoo N. Brain tissue oxygen monitoring in traumatic brain injury and major trauma: outcome analysis of a brain tissue oxygen-directed therapy. J Neurosurg. 2009 Oct;111(4):672-82. doi: 10.3171/2009.4.JNS081150.

ReferenceType: derived

ReferenceCitation: Mistral T, Roca P, Maggia C, Tucholka A, Forbes F, Doyle S, Krainik A, Galanaud D, Schmitt E, Kremer S, Kastler A, Troprès I, Barbier EL, Payen JF, Dojat M. Automated Quantification of Brain Lesion Volume From Post-trauma MR Diffusion-Weighted Images. Front Neurol. 2022 Feb 23;12:740603. doi: 10.3389/fneur.2021.740603. eCollection 2021.

ReferenceCitation: Payen JF, Richard M, Francony G, Audibert G, Barbier EL, Bruder N, Dahyot-Fizelier C, Geeraerts T, Gergele L, Puybasset L, Vigue B, Skaare K, Bosson JL, Bouzat P. Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol. BMJ Open. 2020 Aug 20;10(8):e040550. doi: 10.1136/bmjopen-2020-040550.

lead_sponsor: University Hospital, Grenoble

location_facility: University Hospital of Paris-Salpetriere


title: Frequency of Pompe's Disease and Neuromuscular Etiologies in Patients With Restrictive Respiratory Failure Associated With Signs of Muscle Weakness

summary:
A breach of respiratory function may be one of the elements more or less early or predominant clinical picture of neuromuscular diseases. It is considered that the obstructive syndromes represent 64% and restrictive or mixed syndromes 36% of chronic respiratory insufficiency, approximately 7% due to a neuromuscular disease. The frequency and type of impairment are dependent on the underlying pathology.

The neuromuscular restrictive respiratory failure (IRR) remains partially unknown pulmonologists, especially because the signs of muscle weakness are sometimes difficult to detect. However, respiratory diseases are a major concern in neuromuscular diseases because they can have an impact both on sleep (not sleep, ...) on the daily activities (breathlessness on exertion, dyspnea) and thereby alter the quality of life of patients. Moreover, they represent a significant morbidity and mortality factor. Chest tightness may in some cases reveal the disease and thus constitute the chief complaint of a patient with a neuromuscular disease. In late-onset Pompe disease, lung disease is the predominant clinical symptoms in about 30% of patients.

An algorithm was developed to guide practitioners and help them in their diagnostic approach to the cause of the IRR (diagnostic algorithm ATS / ERS 2005). However, this algorithm does not allow precise identification of the neuromuscular causes.

At the patient level, this can have an impact by extending the time before placing a diagnosis. In Pompe disease, the average time to diagnosis reached 7.9 years. However, there are for this disease a simple and rapid diagnostic test. Therefore, a greater awareness of practitioners with regard to the particular Pompe disease and neuromuscular diseases in general may be beneficial to patients.

This study aims to:

i) awareness pulmonologists to the possibility of neuromuscular an IRR.

ii) characterize the frequency of neuromuscular origin of IRR in a broad population of patients with concomitant signs muscle weakness.

iii) reduce the time to diagnosis by directing patients to neuromuscular reference center early.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CH de Cannes
CHU de Rouen
CHU le Bocage
CHU de St Etienne
Cabinet Dr Pereira-Cortese
CHU de Toulouse
CHRU de Tours
CHI de Créteil
CH d'Escartons
CHU de Nice
Hôpital Saint Louis
Polyclinique les Bleuets
Hôpital Tenon
Hôpital Raymond Poincaré
CHU d'Angers
Centre hospitalier d'Argenteuil
CHU de Brest
CHU de Limoges
Clinique Saint Joseph
CHRU de Lille
GH Pitié Salpêtrière


type: Other Identifier

title: Impact of a Simple Clinical Tool for Increasing Enrollment on a Kidney Transplant Waiting List for Patients Aged Over 70 and Initiating Dialysis

acronym: KITE

summary:
The main objective of this study is to show that the systematic use of a prognostic score as early as possible after the initiation of dialysis in patients over 70 years of age and with a good prognosis at 3 years of dialysis results in an increase in the number of entries on a kidney transplant waiting list at 12 months after the initiation of dialysis.

This prospective assessment is carried out as part of a historico-prospective before-after study in parallel with a survey of changes in national practices over the same time period via a here-elsewhere type study.

Historical data (i.e the. "before" period) will include incident dialysis cases during the calendar years 2013, 2014 and 2015 before the start of the prospective phase (i.e. "after" period, which is represented by the current declaration); since a preliminary study demonstrated that the data are comparable from 2011 to 2013, we will use the average of data thus obtained. Historical data will be retrieved from the REIN (The French Renal Epidemiology and Information Network) registry data and will be validated by investigators at each center.

status: Terminated

primary_purpose: Screening

ReferenceCitation: Dusseux E, Albano L, Fafin C, Hourmant M, Guérin O, Couchoud C, Moranne O. A simple clinical tool to inform the decision-making process to refer elderly incident dialysis patients for kidney transplant evaluation. Kidney Int. 2015 Jul;88(1):121-9. doi: 10.1038/ki.2015.25. Epub 2015 Feb 11.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: Centre Hospitalier Intercommunal du Val d'Ariège

location_facility: CHRU de Montpellier - Hôpital Lapeyronie

location_facility: Centre d'Hemodialyse Languedoc Méditérranéen


title: Evaluation of Human HER-2 Status in Gastric and Gastro-Oesophageal Junction Cancer.

summary: The primary objective is to evaluate the concordance between human epidermal growth factor receptor 2 (HER2) status determined by the participating laboratory and by the centralized laboratory. HER2 status of samples was tested by the participating laboratories (investigator's choice of immunohistochemistry [IHC] and in situ hybridization [ISH] methods) and by the centralized laboratories (IHC using the 4B5 anti-HER antibody and Silver ISH). Positive HER2 status was defined as a score of IHC3+ or IHC2+/ISH+.

time_perspective: Cross-Sectional

intervention_type: Biological


title: Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements

acronym: CLINALK

summary: Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib

time_perspective: Retrospective

ReferenceCitation: Shaw AT, Kim DW, Nakagawa K, Seto T, Crinó L, Ahn MJ, De Pas T, Besse B, Solomon BJ, Blackhall F, Wu YL, Thomas M, O'Byrne KJ, Moro-Sibilot D, Camidge DR, Mok T, Hirsh V, Riely GJ, Iyer S, Tassell V, Polli A, Wilner KD, Jänne PA. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013 Jun 20;368(25):2385-94. doi: 10.1056/NEJMoa1214886. Epub 2013 Jun 1. Erratum in: N Engl J Med. 2015 Oct 15;373(16):1582.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Vénissieux - Groupe Hospitalier Mutualiste les Portes du Sud

location_facility: Saint Herblain - Institut de Cancérologie de l'Ouest - René Gauducheau

location_facility: Vannes - Centre Hospitalier Bretagne Atlantique

location_facility: Paris - Hôpital Européen Georges Pompidou


title: Randomized, Open Label Study to Evaluate Renal Safety of Intravenous Bondronat 6 mg Infusions Over 15 Minutes Versus 60 Minutes in Patients With Metastatic Bone Disease Due to Breast Cancer

summary: This study will evaluate renal function in participants with metastatic bone disease due to breast cancer receiving intravenous (IV) infusions of ibandronate (Bondronat) 6 milligrams (mg), over either 15 minutes or 60 minutes, every 3 weeks. Efficacy and safety of ibandronate in the 2 groups of participants will also be compared. The anticipated time on study treatment is 7 months, and the target sample size is 318 individuals.


acronym: ACE-Lung

title: Phase II Study Evaluating the Combination of Cetuximab With Afatinib as First-line Treatment for Patients With EGFR Mutated Non Small Cell Lung Cancer

ReferenceType: result

ReferenceCitation: Cortot AB, Madroszyk A, Giroux-Leprieur E, Molinier O, Quoix E, Bérard H, Otto J, Rault I, Moro-Sibilot D, Raimbourg J, Amour E, Morin F, Hureaux J, Moreau L, Debieuvre D, Morel H, Renault A, Pichon E, Huret B, Charpentier S, Denis MG, Cadranel J. First-Line Afatinib plus Cetuximab for EGFR-Mutant Non-Small Cell Lung Cancer: Results from the Randomized Phase II IFCT-1503 ACE-Lung Study. Clin Cancer Res. 2021 Aug 1;27(15):4168-4176. doi: 10.1158/1078-0432.CCR-20-4604. Epub 2021 May 24.

location_facility: Montpellier - GCS Centre de Cancérologie du Grand Montpellier

summary:
Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved in several phase III trials with gefitinib, erlotinib or afatinib.

Nevertheless, all patients will progress after 9 to 12 months of treatment due to the appearance of a treatment resistance.

Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that afatinib delay the appearance of resistance.

Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The hypothesis of this study is that the combination between cetuximab and afatinib will permit to delay or decrease the appearance of resistances.


title: A Randomized Phase II Study Evaluating Efficacy and Safety of 2nd or 3rd Line Treatment by Nivolumab Monotherapy or Nivolumab Plus Ipilimumab, for Unresectable Malignant Pleural Mesothelioma (MPM) Patients

ReferenceCitation: Scherpereel A, Mazieres J, Greillier L, Lantuejoul S, Dô P, Bylicki O, Monnet I, Corre R, Audigier-Valette C, Locatelli-Sanchez M, Molinier O, Guisier F, Urban T, Ligeza-Poisson C, Planchard D, Amour E, Morin F, Moro-Sibilot D, Zalcman G; French Cooperative Thoracic Intergroup. Nivolumab or nivolumab plus ipilimumab in patients with relapsed malignant pleural mesothelioma (IFCT-1501 MAPS2): a multicentre, open-label, randomised, non-comparative, phase 2 trial. Lancet Oncol. 2019 Feb;20(2):239-253. doi: 10.1016/S1470-2045(18)30765-4. Epub 2019 Jan 16. Erratum in: Lancet Oncol. 2019 Mar;20(3):e132.

location_facility:
CHU Strasbourg
AP-HM Hôpital Nord
AP-HP Hôpital Bichat
Toulouse - CHU Larrey
Centre Hospitalier - Pneumologie
Avignon - Institut Sainte-Catherine
CHU
AP-HP Hopital Tenon - Pneumologie
Centre Etienne Dolet
CHU Tours - Pneumologie
Pontoise - CH
Angers - CHU
Grenoble - CHU
HCL Lyon Sud
Mulhouse - CH
Toulon - CHI
Rennes - CHU
CHRU Lille - Hopital Calmette
Dijon - CHU
Rouen - CHU
Gustave Roussy

summary: The sponsor raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s) would delay tumor progression in patients with unresectable MPM, experiencing disease progression after one or two lines of chemotherapy including at least first-line with pemetrexed and platinum, without altering significantly the quality of life of patients.


title: A French Protocol for the Treatment of Acute Lymphoblastic Leukemia (ALL) in Children and Adolescents

summary:
A still major question in the field of acute lymphoblastic leukemia (ALL) in children - an extremely heterogeneous disease though curable in 80-90% of children and 70-80% of the adolescents - is the optimal use of L-asparaginase (ASNase). It is known that administering ASNase results in the depletion of asparagine circulating in the blood, which starves the leukemic cells and results in their death. But indeed the use of ASNase varies between protocols considering the different brands, the dose and the administration modalities. Oncaspar (PEGylated E. coli asparaginase, pegaspargase) was thus developed with the goal of reducing the immunogenicity of the native ASNase.

This is a French prospective multicentric cohort study of children and adolescents with ALL, stratified on (i) the type of ALL ( B vs T) and (ii) the anticipated risk (stratified in 3 groups for childhood B-cell precursor (BCP)-ALL and 2 groups for T-cell ALL).

It aims to answer to two different issues:

Randomized question: what is the best way to administer pegaspargase? A cohort of children and adolescents with standard or medium risk ALL will be randomized to receive during induction either one infusion of ONCASPAR® 2500 IU/m2 at D12 or two infusions of ONCASPAR® at 1250 IU/m2 each at D12 and D26. Patients will then receive 2500 IU/m2 or 1250 IU/m2 per dose during consolidation and delayed intensification according to the initial arm of randomization.
Non randomized question: In the High/Very High Risk groups, a non randomized intensification of the scheme of asparaginase administration is proposed during induction therapy: 2 infusions of 2500 IU/m2/day (D12 and D26) will be administered. All patients will receive 2500 IU/m2 per dose during consolidation and delayed intensifications.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
CHU Robert Debré
CHU Saint Louis
CHu
CHU Armand Trousseau
CHRU
CHU
Chu-Ihope


type: Registry Identifier

title: Low Level of Genomic Alteration to Predict Exceptional and Unexpected Response to Targeted Therapies in Patients With Solid Tumors

acronym: EXPRESS

summary: Adult patients with metastatic or locally advanced solid malignancies (including but not limited to breast, cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal cancer, ovarian cancer, renal clear cell cancer, skin cutaneous melanoma), presenting or having presented an exceptional and unexpected response to an antineoplastic targeted therapy.

design_allocation: Non-Randomized

primary_purpose: Other

location_facility: Centre Hospitalier Annecy Genevois (CHANGE) - site d'Annecy

location_facility: Institut de Cancérologie de l'Ouest (site René Gauducheau)

location_facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur

location_facility: Institut de Cancérologie de l'Ouest (site Paul Papin)

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: CHU de Poitiers - Pôle régional de Cancérologie

location_facility: Hôpitaux Drôme-Nord- Site de Romans sur Isère

location_facility: Centre Hospitalier Lyon Sud - Hospices Civils de Lyon


title: Multicentre, Prospective, Randomized, Open-label Study Comparing the Efficacy and Safety of CellCept With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Standard Immunosuppression Comprising CellCept and Long-term Continuation of Cyclosporine in Renal Transplant Recipients Receiving Induction by Zenapax and Treated With Corticosteroids for 8 Months

summary: This multicentre, prospective, randomized, open-label study will compare the safety and efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation of cyclosporine, with those of mycophenolate mofetil and long term continuation of cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction treatment and followed by 8 month treatment with corticosteroids. The anticipated time on study treatment is 12 months. Participants who will complete the initial 12-month study and who will provide written informed consent will be eligible to participate in a 60-month follow-up phase.


title: Safety of Antiepileptic Withdrawal in Long Term Video-EEG Monitoring

acronym: SAVE

summary:
SAVE is a stratified cluster-randomised controlled, parallel group, open-label trial, with Epileptic Monitoring Unit (EMU) as the units of randomisation and patients as the unit of analysis.

The focus of research is the management of AntiEpileptic Drugs (AEDs) withdrawal during long term Video EEG (VEEG) monitoring in patients with drug resistant seizures. This non-standardised medical practice, which aims at promoting the occurrence of seizures during the time limit of the monitoring period, exposes patients to significant risks which should be minimised by harmonisation of practice and a standardised protocol of AEDs withdrawal.

SAVE will assess the impact of a standardised protocol of AEDs withdrawal during long-term VEEG monitoring on the frequency of seizure-related serious adverse events occurring during these monitorings and on the ability to obtain VEEG recording of seizures within appropriate time limits.

10 of the 22 EMUs will be randomised to the group where the standardised protocol of AEDs withdrawal will be used systematically, while the other ten EMUs will continue their current non-standardised practice of AEDs withdrawal, and will serve as a control group.

The setting of the study will include a 6 months evaluation phase, prior to randomisation, during which the organisational characteristics, baseline EMUs' activity, current management of AEDs withdrawal, and rate of Serious Adverse Events (SAEs) of each participating center will be evaluated.

The standardised study protocol of AEDs withdrawal has been defined on the basis of a systematic review of all relevant publications in the field.

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Two Arm, Prospective, Multicenter Randomized Phase II Trial of Neoadjuvant Modified Folfirinox Regimen, With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma

summary: This is a prospective, randomized phase II trial. The aim of this study is to assess the efficacy of two therapeutics strategies. Patients with borderline-resectable pancreatic cancer (BRPC) will be randomly in two arms : neoadjuvant mFolfirinox followed with or without preoperative chemoradiotherapy with capecitabine.

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility:
CHP Saint Grégoire
Chru Nancy
Centre Oscar Lambret
Hôpital Henri Mondor (APHP)
CHU Reims
Chru Tours
Institut Mutualiste Montsouris
Hôpital Paul Brousse
Institut de Cancérologie de l'Ouest
Hôpital Beaujon
Hôpital Européen Marseille
Chu Nantes
Hôpital Cochin (APHP)
Infirmerie Protestante de Lyon
Institut Bergonié
Institut Paoli CALMETTES
CH Bicêtre (APHP)
Hôpital La Timone
Institut du Cancer de Montpellier
Institut de Cancérologie de Lorraine
Chru Lille
Polyclinique Bordeaux Nord
Pitié Salpêtrière (APHP)
CHU Morvan
Chu Colmar
Chu Rouen
Hôpital Haut-Lévêque
Centre Eugène Marquis

intervention_type: Radiation


title: Amniotic Fluid Biomarker Research for Prediction of Postnatal Renal Function in Fetus With a Bilateral Abnormal Renal Development: National, Multicenter, Prospective and Non-interventional Study.

acronym: BIOMAN

summary:
The discovery of antenatal bilateral renal anomaly poses an essential question: can we predict postnatal renal function? Ultrasound is insufficiently precise to predict postnatal renal function evolution.

The objective of this study is to estimate the specificity and sensitivity of amniotic fluid biomarkers to predict postnatal renal function in fetuses with bilateral developmental nephropathies.

Both fetuses with bilateral renal anomalies and control (healthy) fetuses will be included.

For this study amniotic fluid will only be collected according to routine clinical practice and only excess amniotic fluid sample will be used for the study.

The potentially identified biomarkers will not change routine management of the pregnancies in the study.

location_facility: Maison de Sante Protestante de Bagatelle/Bordeaux


title: Comparison of Pre-oxygenation by Non-invasive Ventilation With High-flow Nasal Oxygen Therapy for Intubation of Intensive Care Patients in Cases of Acute Respiratory Failure: A Prospective, Randomized, Controlled Study (FLORALI 2)

summary:
The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation:

NIV (Non Invasive Ventilation)
HFNC (High-flow nasal canula oxygen therapy)

ReferenceCitation: Rodriguez M, Ragot S, Coudroy R, Quenot JP, Vignon P, Forel JM, Demoule A, Mira JP, Ricard JD, Nseir S, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Merdji H, Petitpas F, Vivier E, Mekontso-Dessap A, Nay MA, Asfar P, Dellamonica J, Argaud L, Ehrmann S, Fartoukh M, Girault C, Robert R, Thille AW, Frat JP; REVA Network. Noninvasive ventilation vs. high-flow nasal cannula oxygen for preoxygenation before intubation in patients with obesity: a post hoc analysis of a randomized controlled trial. Ann Intensive Care. 2021 Jul 22;11(1):114. doi: 10.1186/s13613-021-00892-8.

ReferenceCitation: Frat JP, Ricard JD, Quenot JP, Pichon N, Demoule A, Forel JM, Mira JP, Coudroy R, Berquier G, Voisin B, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Clere-Jehl R, Petitpas F, Vivier E, Razazi K, Nay MA, Souday V, Dellamonica J, Argaud L, Ehrmann S, Gibelin A, Girault C, Andreu P, Vignon P, Dangers L, Ragot S, Thille AW; FLORALI-2 study group; REVA network. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial. Lancet Respir Med. 2019 Apr;7(4):303-312. doi: 10.1016/S2213-2600(19)30048-7. Epub 2019 Mar 18.

ReferenceCitation: Frat JP, Ricard JD, Coudroy R, Robert R, Ragot S, Thille AW; on-behalf-of REVA network. Preoxygenation with non-invasive ventilation versus high-flow nasal cannula oxygen therapy for intubation of patients with acute hypoxaemic respiratory failure in ICU: the prospective randomised controlled FLORALI-2 study protocol. BMJ Open. 2017 Dec 22;7(12):e018611. doi: 10.1136/bmjopen-2017-018611.

lead_sponsor: Poitiers University Hospital

location_facility:
CHU louis MOURIER
CHU marseille
CHU Strasbourg
CHU Angers
CHU Lille
Hôpital FOCH
CH
Chu Cochin
CHU La cavale Blanche
CHU La Pitié Salpétrière
CHU Lapeyronie
CHU Poitiers
Hôpital C. NICOLLE
University Hospital of Poitiers
CH Vendée
CH St Joseph St Luc
CHU Guadeloupe
Chu E. Herriot
CH La Rochelle
CHU La Source
Hopital de l'Archet
Chu Tenon
Limoges University Hospital
Chu Tours
Chu Mondor
CHU Dijon
LYON Sud

intervention_type: Procedure


acronym: VISMONEO

title: Phase II Study Evaluating the Interest of Vismodegib as Neo-adjuvant Treatment of Basal Cell Carcinoma (BCC)

lead_sponsor: University Hospital, Lille

location_facility:
Centre hospitalier Lyon Sud
CH de Boulogne sur mer
CHU - Hôpital d'Estaing
Hôpital St André
Hôpital de la Timone
Clinique de Dermatologie
Hôpital Pontchaillou
CHU Ambroise Paré
Hôpital Robert Debré
Hôpitaux de Brabois
CHU de Besançon
Hôpital Saint Eloi
Hôpital Haut-Lévêque
Institut Gustave Roussy
Hôpital Saint-Louis
Hôpital Bichat
CHU Bocage

summary: Open-label, non-comparative, multicenter, phase II study of Vismodegib in patients with locally advanced BCC.


title: A Multicenter Phase II Study of Ipilimumab Combined With a Stereotactic Radiosurgery in Melanoma Patients With Brain Metastases

acronym: IPI+RTS

summary: This is a non-controlled, open label, Phase II Study of ipilimumab combined with a Stereotactic Radiosurgery. The study included an induction phase of four IV infusions of Ipilimumab at 10 mg/kg every 3 weeks associated with a stereotactic radiosurgery performed 3 days before 2nd ipilimumab administration. A Maintenance phase included Ipilimumab, IV, 10 mg/kg once every 12 weeks, starting at week 24, in the absence of PD, unacceptable toxicity or withdrawal of consent or disease progression. The primary objective is the overall survival. The Secondary objectives include safety, ORR, PFS and peripheral blood absolute lymphocyte count (ALC) as a predictive biomarker.

location_facility: Centre Régional de Lutte Contre le Cancer Eugène Marquis


title: Treatment of Chronic Subdural Hematoma by Corticosteroids

acronym: SUCRE

summary: Chronic subdural hematomas are a frequent neurosurgical pathology in the elderly. Gold standard is surgical evacuation of these hematomas. Physiopathology of chronic subdural hematoma involves numerous inflammatory processes which could be inhibited by steroids.

ReferenceCitation: Henaux PL, Le Reste PJ, Laviolle B, Morandi X. Steroids in chronic subdural hematomas (SUCRE trial): study protocol for a randomized controlled trial. Trials. 2017 Jun 5;18(1):252. doi: 10.1186/s13063-017-1990-8.

lead_sponsor: Rennes University Hospital

location_facility:
CHU Besançon
CHU Nantes
CHU Saint Etienne
AP-HM - Hôpital La Timone
CHU Tours
CHU Bordeaux Neurochirurgie A
HC Lyon
CHU Strasbourg
CHU Caen
CHU Poitiers
CHU Angers
CHU Bordeaux Neurochirurgie B
CHU Brest
CHU Lille
CHU Rouen
CHU Nancy
CHU Amiens


title: Analyse du caractère prédictif de l'échographie Ganglionnaire Pour le Diagnostic de bégninité ou malignité d'Une adénopathie Superficielle

acronym: EGAS

summary:
Investigators need to establish a formal diagnostic of superficial adenopathy through complementary investigations to find etiologic diagnostic ( Echography, adenogram).

Echography examination should be a guide to take in charge the adenopathy and to predict presence of malignant (primitive) or benin (reactional) character of adenopathy. The aim of this study is to codify the management of adenopathic patient with a diagnostic in 48 hours after examination. This fast diagnostic helps to prevent unnecessary biopsy, to avoid wasting time in case of a serious pathology.

lead_sponsor: University Hospital, Brest

location_facility:
Cabinet Ergue Gaberit
Cabinet Le Guilvinec
Cabinet Ergue Gaberic
Cabinet Brest
CHIC Quimper
Cabinet Lamneur
Cabinet Plouegat Guerrand
Cabinet Lanmeur
Cabine Le Guivinec
CHRU de Brest
Caninet Brest Centre
Cabinet Brest Centre
Cabinet Penmarch
Cabinet Lesconil
Cabinet Quimper


title: Validation de la Version française du Score de Fatigue " Brief Fatigue Inventory (BFI)

acronym: EAMG

summary:
Fatigue, or asthenia, is an important symptom for the diagnosis and follow-up of patients in routine as well as research oriented clinical practice.

Various questionnaires measuring fatigue have been developed, but few have been validated in french. MFI (Multidimensional Fatigue Inventory) has been validated in french in only one study. BFI (Brief Fatigue Inventory) has been translated but never validated in french language.

The main purpose of this study is to validate psychometrically the french version of BFI.

location_facility:
Cabinet Le Guilvinec
Cabinet Ergue Gaberic
Cabinet Lamneur
Cabinet Plouegat Guerrand
Cabinet Rosporden
Cabinet Lanmeur
Cabinet Penmarch
Cabinet Brest Centre
Cabinet Lesconil
Cabinet Camaret/mer
Cabinet Quimper


title: Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia

acronym: LABMI

summary: B-acute lymphoblastic leukaemia (ALL) is the most common childhood malignancy. Despite enhancement of childhood B-ALL outcome, relapses remain difficult to treat. Several studies in adult acute myeloid leukaemia have shown that proliferation of immunosuppressive cells -particularly T regulatory (Treg) cells and deficient natural killer (NK) cells- was associated with poor response to chemotherapy. However, few studies have been done on childhood ALL and none on relapse of B-ALL. Moreover, a newly described immunosuppressive B cells subset (Breg cells) seems to have a role in oncogenesis in mice model, but its significance has never been evaluated in human cancers. The purpose of this study is to prospectively evaluate the immune status of children newly diagnosed with first relapse of B-cell ALL, and to compare results with those of children treated for B-ALL in complete remission. Classic lymphocytic phenotype, proportions of immunosuppressive cells (Treg cells, deficient NK cells, Cytotoxic T-lymphocyte-associated protein 4 and/or Programmed T cell death 1) and thymopoiesis will be evaluated. The investigators assume that increase of immunosuppressive cells proportions could be associated with B-ALL relapse.

lead_sponsor: University Hospital, Angers

location_facility: University Hospital of Trousseau (Paris)

location_facility: University Hospital of Robert Debre (Paris)


title: Subcutaneous Tocilizumab in Monotherapy or in Combination With csDMARD in Patients With Moderate to Severe Active Rheumatoid Arthritis and Followed by Hospital and Office Based Rheumatologists: Non Interventional Study to Describe Real-World Drug Retention Rate of the Biotherapy at 1 Year

summary: This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).

ReferenceCitation: Hilliquin P, Barnetche T, Baillet A, Flipo RM, Lespessailles E, Roux C, Fardellone P, Gilbert-Marceau A, Idier I, Constantin A, Shipley E, Baudens G, Saraux A. Real-World 1-Year Retention Rate of Subcutaneous Tocilizumab Treatment in Patients with Moderate to Severe Active Rheumatoid Arthritis: TANDEM Study. Rheumatol Ther. 2021 Mar;8(1):95-108. doi: 10.1007/s40744-020-00253-0. Epub 2020 Nov 20.

lead_sponsor: Hoffmann-La Roche

location_facility: Hopital Pierre Nouveau;Medecine C Unite Rhumatologie

location_facility: Hopital Lapeyronie; Immunologie Rhumatologie

location_facility: Infirmerie Protestante; Medecine interne Cancerologie

location_facility: Hopitaux du Leman site Thonon; Rhumatologie

location_facility: Centre medical des coteaux; Rhumatologie

location_facility: Ch Lyon Sud; Rhumato Secteur Jules Courmont

location_facility: CH de Juvisy sur Orge; Consult. externes

location_facility: Hopital Sud Anne de Bretagne; Rhumatologie

location_facility: Cabinet de Rhumatologie MSP de Beaublanc

location_facility: Fondation Hopital Saint Joseph; Rhumatologie

location_facility: CH Jean Rougier; Rhumato Reed Fonctionnelle

location_facility: Ch Louis Pasteur; Rhumato Med Interne Neurologie

location_facility: Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

location_facility: Institut Calot Helio Marin; Rhumatologie

location_facility: Centre Hopsitalier Saint Nazaire; Medecine Polyvalente

location_facility: Hopital Gabriel Montpied; Service de Rhumatologie

location_facility: Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen

location_facility: Hopital Edouard Herriot; Pavillon F Rhumatologie

location_facility: Hopital Instruction Armees Begin; Rhumatologie

location_facility: Hopital De La Croix Saint Simon; Medecine Interne Rhumatologie

location_facility: Hopital Victor Jousselin; Rhumatologie 4EME Sud


title: Evaluation of the Analgesic Effects of Prolonged-release Oxycodone and of Levodopa, Versus Placebo, on Central Neuropathic Pain in Parkinson's Disease: OXYDOPA Trial

acronym: OXYDOPA

summary: This study will be conducted in three parallel groups receiving oxycodone, levodopa or placebo, administered as an add-on therapy, in addition to the usual antiparkinsonian treatment. As this study focuses on chronic central neuropathic pain caused by PD, the effects of study treatments will be evaluated after a 10-week treatment period

ReferenceCitation: Lawn T, Rukavina K, Malcangio M, Howard M, Chaudhuri KR. Response to Mylius et al. Pain. 2022 Mar 1;163(3):e496-e497. doi: 10.1097/j.pain.0000000000002445.

lead_sponsor: University Hospital, Toulouse

location_facility:
University Hospital of Nancy
University Hospital of Limoges
University Hospital of Lille
University Hospital of Clermont-Ferrand
Hospital Pierre Wertheimer
University Hospital of Nantes
University Hospital of Rennes
Chu Toulouse
Henri Mondor Hospital
Pitié-Salpêtrière Hospital
University Hospital of Marseille
University Hospital of Poitiers
University Hospital of Rouen
University Hospital of Strasbourg
University Hospital of Nîmes - Caremeau
CHU Amiens
University Hospital of Bordeaux
Hospital of Aix-en-Provence


acronym: IPSI-PSO

title: A 52-week (Plus Extension Until Commercialization), Single-arm Study to Evaluate Psoriasis Severity and Its Psychosocial Impact Using the Simplified Psoriasis Index (SPI) at 16 Weeks, as Well as Long-term Safety, Tolerability and Efficacy of Secukinumab Administered Subcutaneously in Participants Suffering From Moderate to Severe Psoriasis

lead_sponsor: Novartis Pharmaceuticals

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

summary: Evaluate psoriasis severity and its psychosocial impact using a novel Patient Reported Outcome (the Simplified Psoriasis Index SPI) at 16 weeks, as well as long-term safety, tolerability and efficacy of secukinumab administered subcutaneously during 52 weeks (plus extension) in patients with moderate to severe psoriasis.


title: A Novel Hemostatic Powder for the Endoscopic Treatment of Gastrointestinal Bleeding: Evaluation of Efficacy, Feasibility and Rebleeding Predictive Factors Results From a Multicenter Prospective Study Performed in Routine Practice

acronym: GRAPHE

summary: Hemospray™ is a new endoscopic hemostatic powder. Aims of this multicenter prospective study is to determine effectiveness of Hemospray™ on short and medium term in different clinical situations, predictive factors of rebleeding after Hemospray™ application, and feasibility of the application of hemostatic powder in routine clinical practice studying in a large sample of patients.

ReferenceCitation: Haddara S, Jacques J, Lecleire S, Branche J, Leblanc S, Le Baleur Y, Privat J, Heyries L, Bichard P, Granval P, Chaput U, Koch S, Levy J, Godart B, Charachon A, Bourgaux JF, Metivier-Cesbron E, Chabrun E, Quentin V, Perrot B, Vanbiervliet G, Coron E. A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry). Endoscopy. 2016 Dec;48(12):1084-1095. Epub 2016 Oct 19.

lead_sponsor: Nantes University Hospital

location_country: France Monaco

location_facility: Georges Pompidou University Hospital (AP-HP)

location_facility: Lariboisière University Hospital (AP-HP)

location_facility: Henri Mondor University Hospital (AP-HP)


title: Evolution of the PR Interval in Patients Implanted With a Dual Chamber Pacemaker With Algorithm for Spontaneous AV Conduction Preservation

acronym: PRECISE

summary: Observational study on long PR interval using the SafeR mode in bradycardia patients.

lead_sponsor: LivaNova

location_facility:
CMCM Le Mans
hôpital privé Antony
CH Valenciennes
Clinique des 2 Caps
CH Chartres
HIA Percy
CH Orléans
CH Poissy St Germain
Clinique St Hilaire
CH Evreux
Hôpital Nord
CH Basse Terre
CH Lorient
CH Thionville
CH Alençon
CH Forbach
hôpital St André
Ch Chaumont
CH Villefrance
CH Lannion
CH du Pays d'Aix
Clinique Melun
CMC Port Marly
CH St Malo
NCN Nantes
CH Montfermeil
CH Annecy
CH Haguenau
CH Le Havre
Cabinet Alès
CH Dinan
CHU Poitiers
CH Bourges
Clinique A. Paré
hôpital Sud
Cabinet Creutzwald
Clinique Montpellier
CH St Nazaire
CH Corbeil Essonnes
Cabinet Forbach
CH St Joseph
CH Privé Metz
CH Lomme
Hopital Henri Mondor
CH Douarnenez
CH Helfaut
CHU Caen
CHU La Timone
Cabinet Paris
CHU Brest
CH Sens
Hôpital L. Pasteur
CMCO Evry
Clinique Keraudren
hôpital d'Argenteuil
Cabinet Cherbourg
CCN St Denis
Cabinet Valognes


title: A Randomized Phase II, Multicenter Study Evaluating the Benefit of Adding a Non Steroidal Aromatase Inhibitor to Oral Vinorelbine in Patients With Pretreated Metastatic Breast Cancer

acronym: CHEOPS

summary: The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Centre Hospitalier Intercommunal des Alpes du Sud

location_facility: Centre Hospitalier de l'Agglomération Montargoise


title: A Randomized, Open-label, Comparative, Multicenter, Phase II Study of the Efficacy and Safety of REGorafenib Versus Tamoxifen in Patients With Platinum-sensitive OVARian Carcinoma and Isolated Biological Progression

acronym: REGOVAR

summary: The objective of this randomized phase II is to evaluate the benefit of regorafenib for ovarian patients who reported a confirmed elevated CA-125 level under surveillance or bevacizumab, compared with tamoxifen.

location_facility: Centre Hospitalier Universitaire Bretonneau

location_facility: Centre de Radiothérapie - Clinique Sainte-Anne

location_facility: Centre Hospitalier Universitaire Dupuytren


title: Multicentric, Prospective Open-label Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With Atypical Hemolytic Uremic Syndrome (aHUS)

acronym: STOPECU

summary: Atypical hemolytic syndrome (aHUS) is a severe renal disease affecting children and adults. It is characterized by the occlusion of intrarenal vessels due to the presence of platelet/fibrin thrombi, and leads to end-stage renal disease in up to 2/3 of patients. The discovery of complement alternative pathway as a major risk factor for aHUS has led to the design of a disease-specific treatment, the anti-C5 monoclonal antibody, eculizumab. Complement inhibition using eculizumab has clearly improved the renal outcome of aHUS patients with a dramatic decrease in the risk of end-stage renal disease. However, the optimal duration of eculizumab therapy is still debated. The present study aims to assess the feasibility and safety of the discontinuation of eculizumab treatment in children and adults with aHUS.

ReferenceCitation: Fakhouri F, Fila M, Hummel A, Ribes D, Sellier-Leclerc AL, Ville S, Pouteil-Noble C, Coindre JP, Le Quintrec M, Rondeau E, Boyer O, Provôt F, Djeddi D, Hanf W, Delmas Y, Louillet F, Lahoche A, Favre G, Châtelet V, Launay EA, Presne C, Zaloszyc A, Caillard S, Bally S, Raimbourg Q, Tricot L, Mousson C, Le Thuaut A, Loirat C, Frémeaux-Bacchi V. Eculizumab discontinuation in children and adults with atypical hemolytic-uremic syndrome: a prospective multicenter study. Blood. 2021 May 6;137(18):2438-2449. doi: 10.1182/blood.2020009280.

location_facility:
CHU Strasbourg
CHU Bordeaux
CH métropole Savoie
CHU toulouse
BICHAT
CHU Amiens
CH Dijon
CHU Nice
CHRU Lille
CHU Rouen
Hôpital Européen Georges Pompidou
Hopital Tenon
Hopital FOCH
CHU Nantes
CHU Caen
CHU Montpellier
CH Metz Thionville
Hopital Necker
Ch Le Mans
CH Alpes Léman
CHU lyon
AP-HM


acronym: Btx-HT

title: Evaluation of Botulinum Toxin Injection Efficacy in the Treatment of Head Essential Tremor by a Multi-center, Randomized, Double-Blind, Parallel-group, Placebo-controlled Study

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU d'Amiens
CHU Gui de Chauliac
Hôpital de la Timone
Hôpital R Salendro
Hôpital Haut-Levêque
Hôpital neurologique
Hôpital Jean Minjoz
CHU de Poitiers
CHU de Clermont-Ferrand
Centre Hospitalier Pays D'Aix
Fondation Rothschild
CH F. Mittérand
Hôpital Caremeau
Hôpital de Hautepierre
CHU de Toulouse
AP-HP
CH Narbonne

summary:
Essential head tremor (HT) does not usually respond to drug treatment such as propranolol or primidone or to surgical treatment such as deep brain stimulation of the thalamic ventralis intermedius nucleus. Botulinum toxin (Btx) is widely used and efficient in the treatment of blepharospasm and cervical dystonia. Btx prevents the release of acetylcholine in synapses, leading to a reduction of pathological muscle movement. Very little information is available on its efficacy on HT. Two published reports suggested that local Btx A injections could be an effective and safe approach for treating HT. Given the scarcity of published data (small samples, open studies, different doses of Btx used, heterogeneous populations, several muscles injected, etc.), the aim of this study is to demonstrate the efficacy of Btx injections in essential HT by a multi-center, randomized, double-blind, parallel-group, placebo-controlled study.

Principal objective: To evaluate the efficacy of botulinum toxin injections in the treatment of head tremor.

Secondary objectives:

- To evaluate the tolerance of botulinum toxin injections in the treatment of head tremor.
- To evaluate the impact of botulinum toxin injections on the patients' quality of life and embarrassment.
To evaluate the changes of tremor characteristics induced by a Btx treatment using a 3D accelerometer wireless portable system (Xsens MTw wireless motion tracker system) (tremor frequency, tremor displacement, mean peak amplitude, distance traveled) and a new video system device to analyze head tremor characteristics


title: SYSTEMATIC SURGERY VERSUS SURVEILLANCE AND RESCUE SURGERY IN OPERABLE CANCER OF THE OESOPHAGUS WITH A COMPLETE CLINICAL RESPONSE TO RADIOCHEMOTHERAPY

acronym: Esostrate

summary:
Step 1: Inclusion of eligible patients to carry out a translational search for prognostic and predictive markers of Complete Clinical Response and Pathologic Complete Response (using blood samples and diagnostic biopsies) and to collect data on radiochemotherapy and its toxicity.

The trial will evaluate strategies after neoadjuvant treatment and not RCT protocols. The RCT will thus be chosen by the investigator from published effective schemes in a pre-operative setting or in patients not undergoing surgery.

Evaluation of the response 5 to 6 weeks after the RCT.

Step 2: Randomisation in patients with a complete clinical response:

Arm A: Systematic surgery Arm B: Surveillance and rescue surgery in cases with resectable loco-regional recurrence

Patients not eligible for randomisation will have the possibility to participate in a specific study (information can be obtained from the SAKK group (Switzerland Group Clinical Research on Cancer)).

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Centre d'oncologie et de radiothérapie du Pays Basque


title: A Phase III Study Evaluating Two Neoadjuvant Treatments Radiochemotherapy (5 Weeks - 50Gy+Capecitabine) and Radiotherapy (1week - 25Gy) in Patient Over 75 With Locally Advanced Rectal Carcinoma

acronym: NACRE

summary: The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).

lead_sponsor: UNICANCER

location_facility: Centre Médical Oncogard Institut de cancérologie du Gard

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Gustave Roussy Cancer Campus Grand Paris


title: A Randomized Controlled Study Evaluating the Impact of an Educational Program "EDU-MICI" on Patients With Inflammatory Bowel Disease

acronym: ECIPE

summary: This study has the objective to demonstrate that an education program could have a significant impact on Inflammatory Bowel Disease (IBD) patient's skills with regards to their disease.

primary_purpose: Supportive Care

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Chu Amiens
Hopital Tourcoing
Hopital Nord
Hopital Louis Mourier
Hopital Beaujon
CHU NICE
Chu Rouen
Chu Nantes
Chi Le Raincy Montfermeil
Chu Tours
Hopital Saint Louis
Hopital Saint-Antoine
Chu Montpellier
Chu Saint-Etienne
Chu Toulouse
CHRU Lille
Institut Mutualiste Montsouris
Hopital Bicetre


acronym: SUNRISE

title: A Phase IV, Multicenter, Single-arm and Open-label Study With Omalizumab (Xolair®) in Chronic Spontaneous Urticaria (CSU) Patients Who Remain Symptomatic Despite Antihistamine (H1) Treatment

summary: Evaluate the proportion of patients with an urticaria control test [UCT] score of greater than or equal to 12 at Week 12.


acronym: NEOPAN

title: A Randomized Phase III Trial Comparing Chemotherapy With Folfirinox to Gemcitabine in Locally Advanced Pancreatic Carcinoma

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

location_facility: Groupe Hospitalier du Havre Jacques Monod

location_facility: Institut de cancérologie Lucien Neuwirth

location_facility: Centre Hospitalier Intercommunal Aix-Pertuis

summary: French national multicentric phase III trial evaluating chemotherapy with Folfirinox or gemcitabine in locally advanced pancreatic carcinoma.


title: Characterization of Sensory Neuropathies Associated With Anti-FGFR3 Antibodies

summary:
Sensory neuronopathies affect sensory neuron in the posterior spinal ganglion. They are responsible for pain, balance disorder (ataxia) and the use of hands. They depend on multiple etiologies. In a retrospective study, the investigators showed that the anti-FGFR3 antibody is a diagnostic marker of a subset of sensory neuronopathies. The investigators believe that other antibodies can be discovered in patients who remain seronegative changing.

However, the study is retrospective and only a small number of patients could be identified. Several points therefore need to be clarified or confirmed in a second prospective study.

ReferenceCitation: Tholance Y, Moritz CP, Rosier C, Ferraud K, Lassablière F, Reynaud-Federspiel E, França MC Jr, Martinez ARM, Camdessanché JP, Antoine JC; anti-FGFR3 antibody Study Group. Clinical characterisation of sensory neuropathy with anti-FGFR3 autoantibodies. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):49-57. doi: 10.1136/jnnp-2019-321849. Epub 2019 Nov 5.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Chu Creteil
CH Saint Denis - Hôpital Delafontaine
Chu Strasbourg
CHU Clermont-Ferrand
Hôpital BICETRE
CHU Poitiers
CHU Bordeaux
CH Cornouailles
CHU de Grenoble
CHU de NICE
Hopital Pitie Salpetriere
CHRU de Nantes
Fondation Rothschild
Chu Saint-Etienne
CHU de Limoges
Hospices Civils de Lyon
AP-HM


acronym: CONVERCE

title: Evaluation of Cobimetinib + Vemurafenib Combination Treatment in Patients With Brain Metastasis BRAFV600 Mutated Cutaneous Melanoma

lead_sponsor: Center Eugene Marquis

location_facility:
CHU Tours
Centre Hospitalier du Mans
CHU de Nantes
CHU Albert Michallon
Groupe Hospitalier l'Archet
Hôîtal St louis
Hôpital Cochin
CHU Ambroise Paré
CHU de Dijon
CHU de Bordeaux
CHU Caen - Hôpital Clémenceau
Centre Hospitalier Lyon Sud
Centre Eugène Marquis
Hôpital Henri Mondor
Hôpital Bichat
CHRU Lille
CHU Brest - Hôpital Morvan

summary: The purpose of this study is to determine wether cobimetinib + vemurafenib combination treatment is effective in the treatment of BRAFV600-mutated melanoma patients with brain metastasis


title: Renal Arteries Dysplastic Aneurysms: Anatomopathological and Genetic Study

summary:
Fibromuscular dysplasia (FMD) is localized structural defects in the arterial wall, whose innate or acquired character is still unknown. This segmental non atheromatous injury, leads to stenosis of the arteries of small and medium caliber. Renal arteries are the most commonly affected with 60-75% of total fibrodysplasia. Three histological subtypes have been described: intimal, medial and peri-medial. They are not mutually exclusive and can be observed in the same patient.

This is a rare blood disease, occurring in children and young adults. In this young population with long life expectancy, these aneurysmal lesion are associated with 10% risk of rupture. To date, no data have shown in the literature that FMD is link to genetic causes, or if there is specific histopathologic lesions for non-atherosclerotic renal artery aneurysms.

To answer these questions, Cardiovascular Surgery Unit of the University Hospital of Saint-Etienne, French national reference center for renal artery surgery, in association with the Reference Center for Rare Vascular Disease in Paris, designed the first study for pathological and genetic characteristics of dysplastic renal artery aneurysms in young patients.

location_facility:
CH Emile Roux
CHU Nantes
Hôpital Jeanne de Flandre
Centre Hospitalier A. Gayraud
Hôpital Robert Schuman
Hôpital de la mère et de l'enfant
CH W. Morey
Hôpital Gabriel Montpied
CHRU Tours
Hôpital Européen Georges Pompidou
Groupe Hospitalier Pellegrin
CHU Saint-Jacques
CH Louis Pasteur
CH Niort
Clinique Saint-Germain
CH Henri Mondor
Hôpital Lapeyronie


title: Multicentre Randomized Cross-over Study Assessing in Type 1 Diabetic Patients With Pump Insulin the Non-inferiority of Glycemic Control Obtained With the Algorithms Tested in DIABRASPORT Versus the Rest Period Without Physical Activity

summary:
There is no specific recommendations on the adjustments of the insulin treatment in the event of physical activity (PA) in T1D patients treated on insulin pump therapy. Patients often prefer additional carbohydrates intake rather than the reduction of their insulin doses because of the lack of specific algorithms.

The DIABRASPORT 2 study aims to demonstrate that using algorithms DIABRASPORT, during a week of physical activity (PA), the incidence of hypoglycaemia is not different from that obtained during a week of rest without physical activity.

It is a multi-center European, controlled, randomized, cross-over, study, in 100 T1D patients practicing an occasional AP.

25 centers involved in this study.

After agreeing to participate in the study, patients will read the information leaflet, ask questions to the investigator physician and they will date and sign the consent form. The investigator physician will do the same.

They will be then drawn randomly via the electronic CRF (eCRF) to determine the order in which they will realize the rest vs DIABRASPORT sessions.

The study will take place in 5 weeks:

During the weeks Baseline and Diabrasport, patients will have to make 3 physical activity of 30 to 60 minutes separated by at least 24 hours:

moderate activity 3 hours after lunch
intense activity 3 hours after lunch
activity moderate 90 min after lunch They will use their usual algorithms (Cho intake or adjustment of the dose of insulin) during the week Baseline and they will use the Diabrasport algorithm during the week Diabrasport.

Patients will be equipped with a holter Glycemic iPro2, Medtronic, whose data are hidden.

During the week of rest, patients should do no physical activity during the week. They will be equipped with the Glycemic holter.

Patients will have to fill a food survey the days they practice PA. Between each period, the patient must respect a period of wash-out for one week at least, during which he will be asked to not practice physical activity.

Validation of algorithms simple, easy to implement, adaptable by patients, could help to improve balance metabolic and practice of sport among the T1D.

primary_purpose: Basic Science

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility: Centre Hospitalier Régional Universitaire


title: Effects of Low-dose Corticosteroids on Survival of Severe Community-acquired Pneumonia

summary:
Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of inflammation-associated systemic complications. Two recent meta-analyses suggest a positive effect on severe CAP day 28 survival when CTx are added to standard therapy. However they are based on only four trials gathering less than 300 patients, of which only one was positive. Recently published guidelines do not recommend CTx as part of CAP treatment. Therefore a well-powered trial appears necessary to test the hypothesis that CTx - and more specifically hydrocortisone - could improve day 28 survival of critically-ill patients with severe CAP, severity being assessed either on a Pulmonary Severity Index ≥ 130 (Fine class V) or by the use of mechanical ventilation or high-FiO2 high-flow oxygen therapy.

A phase-III multicenter add-on randomized controlled double-blind superiority trial assessing the efficacy of hydrocortisone vs. placebo on Day 28 all-causes mortality, in addition to antibiotics and supportive care, including the correction of hypoxemia.

Randomization will be stratified on: (i) centers; (ii) use of mechanical ventilation at the time of inclusion.

ReferenceCitation: Dequin PF, Heming N, Meziani F, Plantefève G, Voiriot G, Badié J, François B, Aubron C, Ricard JD, Ehrmann S, Jouan Y, Guillon A, Leclerc M, Coffre C, Bourgoin H, Lengellé C, Caille-Fénérol C, Tavernier E, Zohar S, Giraudeau B, Annane D, Le Gouge A; CAPE COVID Trial Group and the CRICS-TriGGERSep Network. Effect of Hydrocortisone on 21-Day Mortality or Respiratory Support Among Critically Ill Patients With COVID-19: A Randomized Clinical Trial. JAMA. 2020 Oct 6;324(13):1298-1306. doi: 10.1001/jama.2020.16761.

lead_sponsor: University Hospital, Tours

location_facility: Service de Réanimation Médicale, CHU de Nancy

location_facility: Service des Maladies Infectieuses et Réanimation Médicale, CHU de Rennes

location_facility: Service de Réanimation HIA Clermont-Tonnerre

location_facility: Service de Réanimation Polyvalente - Surveillance Continue, CH de Montauban

location_facility: Service de Réanimation - Unité de Soins Continus, CH d'Angoulême

location_facility: Service de Réanimation Médicale, Hôpital de Hautepierre, CHU de Strasbourg

location_facility: Service de Réanimation Médicale et Médecine Interne, CHU de Poitiers

location_facility: Service de Réanimation Médicale, Hôpital Louis Pasteur, Chartres

location_facility: Service de Réanimation, Hôpital Louis Mourier

location_facility: Service de Réanimation, CHU Côte de Nacre

location_facility: Service de Réanimation Polyvalente, Hôpital Salengro, CHU de Lille

location_facility: Service de Réanimation Médicale, CHU de Dijon

location_facility: Service de Réanimation Médicale, CHU de Brest

location_facility: Service de Réanimation Médicale, Hôpital Nord

location_facility: Service de Réanimation Polyvalente, CHD La Roche sur Yon

location_facility: Service de Réanimation Polyvalente, Hôpital Hôtel Dieu, CHU de Nantes

location_facility: Service de Réanimation Polyvalente, CH d'Argenteuil

location_facility: Service de Réanimation Médico-Chirurgicale, Hôpital Raymond Poincarré, APHP

location_facility: Service de Réanimation Polyvalente, CH de Saint Malo

location_facility: Service de Réanimation et USC médico-chirurgicale, Hôpital Tenon, APHP

location_facility: Service de Réanimation, CHR Metz-Thionville

location_facility: Service de Réanimation Médicale, Nouvel Hôpital Civil, CHU de Strasbourg

location_facility: Service de Réanimation Médicale, CHR d'Orléans

location_facility: Service de Réanimation Polyvalente, CHU de Limoges

location_facility: Service de Réanimation Médicale Polyvalente, Hôpital G Montpied

location_facility: Service de Réanimation Médicale, CHU de Grenoble

location_facility: Service de Réanimation Médicale, Hôpital Cochin, APHP


title: Circulating Tumor Cells and Early Diagnosis of Lung Cancer in Patients With Chronic Obstructive Pulmonary Disease

acronym: AIR

summary:
This trial is intended to evaluate the value of circulating tumor cells (CTC), in combination with unenhanced (without injection of contrast media) low dose (to limit the effective radiation dose below 1,5 mSv) chest computed tomography (LDCT) in the screening of Lung cancer (LC).

LDCT screening was shown to reduce LC mortality in smokers and ex-smokers, older than 55 years, with a history of more than 30 pack-years. LDCT however shows a close to 30% rate of false positive that require repeat follow-up and also invasive investigations, but also false negatives with metastatic LC being discovered between screening rounds.

Migration of circulating tumor cells (CTC) is an early event of carcinogenesis and characterizes aggressive cancers. We recently showed that CTC can be detected with the ISET technique in a population at high risk for LC, i.e. COPD patients before LC was detectable on LDCT.

The study will focus on patients at very high risk for lung cancer i.e. smokers and ex-smokers suffering Chronic Obstructive Pulmonary Disease (COPD).

The study will enroll 600 participants who will undergo three rounds of screening at one year intervals, each round combining search for CTC on a blood sample and LDCT. Each participant will be followed for at least one year after the last screening round

ReferenceCitation: Ilie M, Hofman V, Long-Mira E, Selva E, Vignaud JM, Padovani B, Mouroux J, Marquette CH, Hofman P. "Sentinel" circulating tumor cells allow early diagnosis of lung cancer in patients with chronic obstructive pulmonary disease. PLoS One. 2014 Oct 31;9(10):e111597. doi: 10.1371/journal.pone.0111597. eCollection 2014.

ReferenceCitation: Marquette CH, Boutros J, Benzaquen J, Ferreira M, Pastre J, Pison C, Padovani B, Bettayeb F, Fallet V, Guibert N, Basille D, Ilie M, Hofman V, Hofman P; AIR project Study Group. Circulating tumour cells as a potential biomarker for lung cancer screening: a prospective cohort study. Lancet Respir Med. 2020 Jul;8(7):709-716. doi: 10.1016/S2213-2600(20)30081-3. Erratum in: Lancet Respir Med. 2020 Dec;8(12):e94.

ReferenceCitation: Leroy S, Benzaquen J, Mazzetta A, Marchand-Adam S, Padovani B, Israel-Biet D, Pison C, Chanez P, Cadranel J, Mazières J, Jounieaux V, Cohen C, Hofman V, Ilie M, Hofman P, Marquette CH; AIR Project Study Group. Circulating tumour cells as a potential screening tool for lung cancer (the AIR study): protocol of a prospective multicentre cohort study in France. BMJ Open. 2017 Dec 26;7(12):e018884. doi: 10.1136/bmjopen-2017-018884.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CHU d'Amiens
CHU de Rouen
CHU de Grenoble
Hôpital Nord
Hôpital Cochin
CHU de Dijon
Hôpital Européen Georges Pompidou
Hôpital TENON
CHU de Saint Etienne
CHU de Strasbourg
CHU de Reims
CHRU de Lille
CH de Roubaix
CHU de Montpellier
CHU de Toulouse
Hospices Civils de Lyon
Hôpital Bichat
CHU de Tours
CHU de Nancy
CHU de Rennes


title: Evaluation of the Information of the Patient Before a Scheduled Coronarography

acronym: INFOCORO

summary: French study, multicentrique with the cooperation of several hospital centers . 700 patients (200 in the stage 1 and 500 in the stage 2). Every patient will complete questionnaires in a anonymous way.

ReferenceCitation: Lattuca B, Barber-Chamoux N, Alos B, Sfaxi A, Mulliez A, Miton N, Levasseur T, Servoz C, Derimay F, Hachet O, Motreff P, Metz D, Lairez O, Mewton N, Belle L, Akodad M, Mathivet T, Ecarnot F, Pollet J, Danchin N, Steg PG, Juillière Y, Bouleti C; INFOCORO investigators. Impact of video on the understanding and satisfaction of patients receiving informed consent before elective inpatient coronary angiography: A randomized trial. Am Heart J. 2018 Jun;200:67-74. doi: 10.1016/j.ahj.2018.03.006. Epub 2018 Mar 12.

lead_sponsor: French Cardiology Society

location_facility: Groupe intercommunal Le Raincy Montfermeil


title: Evaluation of the Impact of a Nurse-led Telephone Follow-up on Treatment Compliance of Patients Treated From a Locally Advanced or Metastatic Non-small-cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) Mutation(s).The PARTAGE Study.

summary:
The study will take place over a period of 27 months. The recruitment phase will last approximately 24 months and each patient will participate for approximately 3 months.

At the inclusion visit (D0), the investigator will ask the patient whether he would like to participate in the study and will obtain his written consent.

Patients agreeing to participate will be randomised (3:1 ratio) and included in one of the following 2 groups:

Group without 'remote additional personalised nurse-led follow-up: patients will receive the healthcare given routinely by their medical team (100 patients).

Group with 'remote additional personalised nurse-led follow-up: patients will receive telephone calls from a nurse in addition to the healthcare given routinely by their medical team (300 patients).

All the patients will be seen according to normal practice by the study medical team.

Patients in the group with 'remote additional personalised nurse-led follow-up will be contacted 8 times during the study (at D1, D7, D14, D21, D28, D44, D59 and D89). The nurse will make sure that the treatment takes place in good conditions; she cannot intervene in the medical care of the patient, nor give answer to the questions relative to the disease or to the treatment of the patient. The medical team remains the privileged contact of the patient.

lead_sponsor: Boehringer Ingelheim

location_facility: HOP Centre Hospitalier de Mulhouse, Pneumo, Mulhouse

location_facility: Centre médical N de Pontoux, Oncologie, Chalon sur Saône

location_facility: Centre Hospitalier Intercommunal, Oncolgie, Crétail

location_facility: HOP Saint Joseph et Saint Luc, Pneumo, Lyon

location_facility: HOP Hôpital Robert Boulin, Pneumo, Libourne

location_facility: HOP CHD La Roche sur Yon - Montaigu - Luçon, Pneumo

location_facility: HOP Nord Ouest de Villefranche, oncologie, Gleize

location_facility: CLI Polyclinique du Parc Rambot, Pneumo, Aix en Provence

location_facility: HOP Centre Hospitalier de Saint Quentin, Pneumo, St-Quentin

location_facility: HOP Centre Hospitalier Pays d'Aix, Pneumo, Aix en Provence

location_facility: HOP CH Emile Roux Le Puy, Pneumo, Le puy en Velay

location_facility: CTR d'Oncologie de Gentilly, Onco, Nancy

location_facility: HOP Centre Hospitalier de Béziers, Pneumo, Béziers


title: Etude Exploratoire randomisée Comparant le Traitement Par Gemtuzumab Ozogamicin /Cytarabine au Traitement Standard Par Idarubicine/Cytarabinechez Les Sujets âgés de 60 à 80 Ans et présentant Une LAM et un Caryotype Non défavorable

summary:
Purpose : The main objective of this study is to assess the efficacy and tolerance of the addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition with standard doses of Ara-C in previously untreated patients aged 60 to 80 years with de novo acute myeloblastic leukemia (AML) and non adverse cytogenetics. The main end point for efficacy is 2 years-event free survival. The secondary efficacy endpoints are CR/Cri rates, cumulative incidence of relapse and overall survival. The secondary endpoints for safety are early death rate (before day 30 and 60), grade 3 to 5 adverse events and severe adverse events, cardiac toxicity and quality of life. Additional secondary endpoints are treatment by covariate interactions with respect to biological characteristics present at diagnosis (CD33 positivity, cytogenetic, molecular abnormalities) or after treatment (Minimal residual disease levels). This study is an exploratory study. Patients will be allocated at inclusion with a 2/1 ratio either to receive treatment with GO and cytarabine or Idarubicin and cytarabine in a 3+7 regimen similar to the "backbone" ALFA 1200 scheme used concurrently by the ALFA group as treatment of AML patients aged >60 years.

Primary objective. The primary objective is to assess the efficacy of two doses of Gemtuzumab ozogamicin (GO) during induction and one dose of GO during first consolidation in combination with Cytarabine in elderly patients with AML in the non adverse cytogenetics-risk group.

lead_sponsor: Versailles Hospital

location_facility:
HIA Percy
Hôpital Huriez, CHU de Lille
Institut de Cancérologie de la Loire
CH Avicenne
IGR
Hôpital V. Dupouy
Centre Antoine Lacassagne
CH Dunkerque
Hopital St Louis
Hôpital Saint Antoine
Centre H Becquerel
CHU d'Orléans
Hôpital de la Conception
Hopital Henri Mondor
CHU Lyon Sud
CHU Caen
CH Versailles
C.H.U d'Amiens - Hôpital Sud
CHU Limoges
Hopital Necker
CHU Dijon


acronym: BacloTox

title: Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment: Double Blinded Comparison Between Botulinum Toxin and Baclofen.

lead_sponsor: University Hospital, Toulouse

ReferenceCitation: Jørgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Støier M, Olsen TS. Outcome and time course of recovery in stroke. Part II: Time course of recovery. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 May;76(5):406-12.

ReferenceCitation: Jørgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Støier M, Olsen TS. Outcome and time course of recovery in stroke. Part I: Outcome. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 May;76(5):399-405.

ReferenceCitation: Kwakkel G, Kollen B, Twisk J. Impact of time on improvement of outcome after stroke. Stroke. 2006 Sep;37(9):2348-53. Epub 2006 Aug 24.

ReferenceCitation: Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, Wellwood I, Langhorne P. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004 Nov;35(11):2529-39. Epub 2004 Oct 7. Review.

ReferenceCitation: Feeney DM, Gonzalez A, Law WA. Amphetamine, haloperidol, and experience interact to affect rate of recovery after motor cortex injury. Science. 1982 Aug 27;217(4562):855-7.

ReferenceCitation: Goldstein LB, Davis JN. Physician prescribing patterns following hospital admission for ischemic cerebrovascular disease. Neurology. 1988 Nov;38(11):1806-9.

ReferenceCitation: Goldstein LB, Davis JN. Clonidine impairs recovery of beam-walking after a sensorimotor cortex lesion in the rat. Brain Res. 1990 Feb 5;508(2):305-9.

ReferenceCitation: Goldstein LB. Influence of common drugs and related factors on stroke outcome. Curr Opin Neurol. 1997 Feb;10(1):52-7. Review.

ReferenceCitation: Goldstein LB. Potential effects of common drugs on stroke recovery. Arch Neurol. 1998 Apr;55(4):454-6.

ReferenceCitation: Goldstein LB. Effects of amphetamines and small related molecules on recovery after stroke in animals and man. Neuropharmacology. 2000 Mar 3;39(5):852-9. Review.

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location_facility: l'Institut Hélio Marin de la côte d'azur

location_facility: Groupe Pellegrin, University Hospital Bordeaux

summary: Stroke is the first cause of motor impairment and disability in adults. Then the main objective of rehabilitation during the first six months following stroke is to facilitate motor recovery. Many post-stroke hemiplegics develop spasticity which is responsible for an increase of disability. Then antispastic drugs are frequently prescribed to the patients even during the post-stroke recovery phase. Until recently most of french patients were treated by oral tablets of baclofen. Now the number of patients receiving intramuscular injections of botulinum A toxin is increasing. However in the literature, these drugs have been tested in post-stroke spasticity during the chronicle phase, after the sixth month and their action on motor recovery remain largely unknown. Then it is necessary to evaluate more accurately the effects of its drugs on motor recovery. The main criterion of its study is the time course of Fugl-Meyer Motor Assessment (FMA). Spastic patients with a single stroke, since less than two months, will be included in the try. They receive at the same time oral tablets for five months and intramuscular injections. Patients are randomized in three arms planned with a distribution balanced by group of 5 patients with a 2 -2- 1 model: botulinum toxin and placebo baclofen (120 patients), oral baclofen and placebo botulinum toxin (120 patients), placebo baclofen and placebo botulinum toxin (60 patients). The FMA score will be assessed before treatment start, one month and three months later. Spasticity, functional abilities, capacity in the activities of daily life, pain and quality of life will be also assessed during the study with Tardieu score, Rivermead Motor Assessment scale, Barthel index, Rankin score, Visual Analogic Scale and Reintegration to Normal Life Index respectively. A positive difference of 12 points in the time course of FMA in the botulinum toxin group in comparison with the baclofen group will be considered as the minimum relevant effect. 300 patients have been planned to be included in 20 centers during the 2 years of trial.


title: Evaluation of Liver Grafts With FibroScan® Before Organ Retrieval in Patients With Brain Death

acronym: FIBROSCAME

summary:
According to the French Biomedicine Agency annual report on retrieval activities and transplants, 1,164 liver transplants were performed in 2011 and 1,161 in 2012. If the amount of brain death donors and retrieved liver grafts appears relatively stable, it remains clearly insufficient compared to the increasing number of patients on the waiting list for liver transplantation (2,462 in 2011). The median time on the waiting list before liver transplantation which was established from the cohort of patients registered between 2007 and 2011 (excluding patients registered for emergency transplantation and for living related-donor transplantation) increased significantly from 4.4 months between 2007 and 2009 to 6.6 months between 2010 and 2011. In order to compensate for the lack of liver grafts, donors acceptance criteria were broadened. For example, alternative transplantation lists were created with liver grafts coming from so-called "marginal" donors. However, despite these efforts, livers were retrieved on only two out of three brain death donors, i.e. in 1,572 and 1,589 organ donors in 2011 and 2012, respectively. This is unfortunately not enough to meet the increasing needs in liver grafts and a growing number of patients wait each year for transplant. Strategic lines of improvement were defined in order to meet the "2012-2016 transplant perspective" which targets 5,700 transplants carried out in 2015 (+5% every year, all transplants included, with 5,023 transplants in 2012).

According to the last consensus conference on liver transplantation of the HAS (French High Authority of Health) the assessment of the degree of macrovacuolar and microvacuolar steatosis determines the possibility to retrieve the graft or not. Liver steatosis consists in an accumulation of fatty droplets in hepatocytes. Its prevalence is high, ranging from 16% to 31% in the general population, and increases up to 46% in heavy drinkers and to 50-80% in the obese population. Steatosis results mostly from alcohol consumption and from metabolic syndrome (obesity, type 2 diabetes, hypertriglyceridemia) called non-alcoholic fatty liver disease (NAFLD), and is more rarely secondary to viral hepatitis or exposure to certain medications. NAFLD involves up to 30% of the population in Western countries and its prevalence is increasing. NAFLD may lead to asymptomatic steatosis, but also to steatohepatitis or advanced fibrosis including cirrhosis and its complications Accordingly, the improvement of liver grafts selection based on objective quantitative criteria which takes into account the degree of liver steatosis appears crucial to increase the number of hepatic transplants.

lead_sponsor: University Hospital, Limoges

location_facility:
AP-HP Henri MONDOR
University Hospital
Estaing University Hospital
Croix Rousse Hospital
Univesity Hospital
AP-HP Kremlin Bicêtre
Nice University Hospital