title: Impact of Not Measuring Residual Gastric Volume on Nosocomial Pneumonia Rates in Mechanically Ventilated Patients Receiving Early Enteral Feeding: a Randomized-controlled Study

summary: Early enteral feeding is a key component of the management of critically ill patients receiving mechanical ventilation. However, enteral feeding has been associated with serious complications such as aspiration followed by ventilator-associated pneumonia (VAP). Many critically ill patients experience poor tolerance of early enteral nutrition because of impaired gastric motility, which leads to a sequence of delayed gastric emptying, increased gastric volume, gastroesophageal reflux, vomiting, aspiration, and VAP. Routine monitoring of residual gastric volume (RGV) to minimize the risk of aspiration is standard practice. RGV is assumed to reflect gastric content, with high RGVs indicating impaired gastric emptying that requires discontinuation of enteral feeding in order to prevent aspiration.However, RGV measurement is neither standardized nor validated. The cut-off value that may indicate an increased risk of aspiration and therefore a need for discontinuing enteral feeding has not been determined, and cut-offs used in studies have ranged from 150 to 500 ml. No data are available to support a correlation between RGV and the rates of adverse events. In experimental studies, RGV failed to correlate with vomiting, aspiration, or VAP. The investigators hypothesize that RGV monitoring fails to decrease the risk of VAP and leed to inappropriate interruptions in enteral feeding with a risk of underfeeding. To assess the effects of not measuring RGV on VAP and enteral feeding delivery, the investigators designed a prospective randomized controlled study.

ReferenceCitation: Reignier J, Mercier E, Le Gouge A, Boulain T, Desachy A, Bellec F, Clavel M, Frat JP, Plantefeve G, Quenot JP, Lascarrou JB; Clinical Research in Intensive Care and Sepsis (CRICS) Group. Effect of not monitoring residual gastric volume on risk of ventilator-associated pneumonia in adults receiving mechanical ventilation and early enteral feeding: a randomized controlled trial. JAMA. 2013 Jan 16;309(3):249-56. doi: 10.1001/jama.2012.196377.

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
CHU Orléans - Réanimation Médicale
CHD Vendée - Service de Réanimation
CHU Poitier - Réanimation Médicale
CHU Tours - Réanimation Polyvalente
CHU Limoges - Réanimation Polyvalente
CH Angoulème - Réanimation Polyvalente


status: Suspended

primary_purpose: Supportive Care

acronym: TALViSoP

intervention_type: Drug

title: Procedures of Locoregional Analgesia and Quality of Life in Palliative Care

study_completion_date_type: Anticipated

lead_sponsor: University Hospital, Limoges

source: euctr

study_type: Interventional

enrollment_type: Anticipated

location_facility: Centre Hospitalier Universitaire - Hôpital Saint André

summary:
Number of patients in mobile palliative care units have pain of both nociceptive and neuropathic origin. In certain cases, procedures of locoregional analgesia can be helpful.

The Purpose of this study is to evaluate the impact of techniques of locoregional analgesia in a palliative population

lead_sponsor_type: academique

status_simplified: Unknown


title: Assess the Risk-benefit Balance of the New Vacuum Assisted-delivery Device "iCUP" Versus the Reference Vacuum. Multicenter Prospective Randomized Controlled Study

acronym: ICUP

summary: The hypothesis is that the new vacuum assisted delivery device iCup is more effective than the reference cup, in terms of maternal and newborn morbidities and functioning

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Chalmers JA, Chalmers I. The obstetric vacuum extractor is the instrument of first choice for operative vaginal delivery. Br J Obstet Gynaecol. 1989 May;96(5):505-6.

ReferenceCitation: Johanson R, Menon V. Soft versus rigid vacuum extractor cups for assisted vaginal delivery. Cochrane Database Syst Rev. 2000;(2):CD000446. Review. Update in: Cochrane Database Syst Rev. 2010;(11):CD000446.

ReferenceCitation: Miksovsky P, Watson WJ. Obstetric vacuum extraction: state of the art in the new millennium. Obstet Gynecol Surv. 2001 Nov;56(11):736-51. Review.

ReferenceCitation: Schaal JP, Riethmuller D, Menget A. Extractions instrumentales du fœtus : ventouse obstétricale. Encycl Méd Chir Paris: Elsevier, 2004 (vol Obstétrique)

ReferenceCitation: Attilakos G, Sibanda T, Winter C, Johnson N, Draycott T. A randomised controlled trial of a new handheld vacuum extraction device. BJOG. 2005 Nov;112(11):1510-5.

ReferenceCitation: Vacca A. A randomised controlled trial of a new handheld vacuum extraction device. BJOG. 2006 Apr;113(4):492; author reply 494-5.

ReferenceCitation: Groom KM, Jones BA, Miller N, Paterson-Brown S. A prospective randomised controlled trial of the Kiwi Omnicup versus conventional ventouse cups for vacuum-assisted vaginal delivery. BJOG. 2006 Feb;113(2):183-9.

ReferenceCitation: Schaal JP, Equy V, Hoffman P. [Comparison vacuum extractor versus forceps]. J Gynecol Obstet Biol Reprod (Paris). 2008 Dec;37 Suppl 8:S231-43. doi: 10.1016/S0368-2315(08)74761-6. French.

ReferenceCitation: Riethmuller D, Ramanah R, Maillet R, Schaal JP. [Vacuum extractors: description, mechanics, indications and contra-indications]. J Gynecol Obstet Biol Reprod (Paris). 2008 Dec;37 Suppl 8:S210-21. doi: 10.1016/S0368-2315(08)74759-8. French.

ReferenceType: derived

ReferenceCitation: Verma GL, Spalding JJ, Wilkinson MD, Hofmeyr GJ, Vannevel V, O'Mahony F. Instruments for assisted vaginal birth. Cochrane Database Syst Rev. 2021 Sep 24;9:CD005455. doi: 10.1002/14651858.CD005455.pub3. Review.

ReferenceCitation: Equy V, David-Tchouda S, Dreyfus M, Riethmuller D, Vendittelli F, Cabaud V, Langer B, Margier J, Bosson JL, Schaal JP. Clinical impact of the disposable ventouse iCup® versus a metallic vacuum cup: a multicenter randomized controlled trial. BMC Pregnancy Childbirth. 2015 Dec 15;15:332. doi: 10.1186/s12884-015-0771-1.

lead_sponsor: University Hospital, Grenoble

location_facility:
Hospital
University Hospital

intervention_type: Device

status_simplified: Completed


title: Confocal Endomicroscopy in Patients With High Risk of Colorectal Cancer: Potential for Diagnosis of Early Neoplasia

summary: The principle objective of this study is to validate confocal endomicroscopy (CEM) in a national, multicenter study, in terms of its ability to diagnose neoplastic lesions in vivo, in two groups of patients at high risk of colorectal cancer (CRC): patients with familial adenomatous polyposis (FAP) after colectomy in whom the neoplastic lesions are probably under-diagnosed, and patients with inflammatory bowel diseases (IBD) in whom endoscopic surveillance is particularly difficult. Methods: The study will be comprised of two phases (Phase I and II). Phase I will serve to validate at the multicenter level the results of the first, recently published, monocenter German study in terms of capacity of CEM to identify the colonic neoplastic lesions in vivo. Phase II is destined to prospectively evaluate the diagnostic yield of CEM in detection and prediction of neoplastic lesions by developing and adding new features to the confocal pattern of in vivo diagnosis. Two cohorts of patients will be studied in parallel: Patients with inflammatory bowel diseases (IBD), like ulcerative colitis (UC) or Crohn's disease (CD), including those before planned colectomy, and patients with FAP after colectomy. During lower endoscopy performed under general anaesthesia, each colonic segment will be examined before and after staining with indigo-carmin. After intra-venous fluorescein injection, all macroscopically abnormal lesions will be examined by CEM, then biopsied. In parallel, multiple random biopsies will be performed, each coupled with simultaneous CEM "optical biopsy" at the same point. In addition, during Phase II, in IBD patients before planned colectomy and in patients with FAP, a "mapping" of colonic mucosa, by obtaining a very high number of CEM "optical biopsies", will be performed, and will be correlated with standard histology performed either on colectomy specimens (IBD) or on standard biopsies (FAP). Principal analysis (Phase I and II) will include evaluation of inter-observer variation in terms of interpretation of in vivo histology and diagnostic yield of CEM with respect to the detection of neoplastic lesions by evaluation of sensitivity and specificity, using standard histology as reference method. Additional analysis (Phase II) will be performed to evaluate the diagnostic and predictive (CRC risk) value of "colonic mapping" by correlating optical images pattern score to results of standard histology. Expected results: This study should guarantee high quality data, standardization of procedures and of interpretation of CEM images, which are prerequisite for dissemination of CEM in clinical practice. The investigators expect to show that CME allows to reliably discriminate between neoplastic and non-neoplastic lesions, that, compared to standard histology, provides better characterization of lesions, especially in the context of extended lesions like in IBD, an finally, that CME images can be used to develop a new "optical biopsy"-based score allowing prediction of high CRC risk in patients with FAP and IBD. The investigators believe that CEM may increase, as compared to currently used techniques, the diagnostic yield in terms of probability of the detection of neoplastic lesions in patients at high risk of CCR, and may become a new standard for endoscopic surveillance in these patients.

status: Terminated

primary_purpose: Diagnostic

lead_sponsor: Nantes University Hospital

location_facility:
Hôpital Saint Philibert
Institut Paoli Calmettes
CHU de Nantes
CHU de Toulouse
Hôpital Lyon Sud
CHU de Lille


title: A Phase I, Open-label, Dose-escalating Study of the Safety or Percutaneous Intra-tumoral Injection of TG4023 (MVA-FCU1) Combined With Systemic Administration of 5-fluorocytosine in Patients With Primary or Secondary Hepatic Tumors.

summary: This trial is a phase I, open-label, dose-escalating study of the safety or percutaneous intra-tumoral injection of TG4023 (MVA-FCU1) combined with systemic administration of 5-fluorocytosine in patients with primary or secondary hepatic tumors.

design_allocation: Non-Randomized

ReferenceCitation: Erbs P, Findeli A, Kintz J, Cordier P, Hoffmann C, Geist M, Balloul JM. Modified vaccinia virus Ankara as a vector for suicide gene therapy. Cancer Gene Ther. 2008 Jan;15(1):18-28. Epub 2007 Nov 9.

ReferenceCitation: Husseini F, Delord JP, Fournel-Federico C, Guitton J, Erbs P, Homerin M, Halluard C, Jemming C, Orange C, Limacher JM, Kurtz JE. Vectorized gene therapy of liver tumors: proof-of-concept of TG4023 (MVA-FCU1) in combination with flucytosine. Ann Oncol. 2017 Jan 1;28(1):169-174. doi: 10.1093/annonc/mdw440.

lead_sponsor: Transgene

location_facility:
Institut Paoli Calmette,
Centre René Gauducheau
Institut Claudius Regaud
Hôpitaux Civils de Lyon,
Hôpitaux Civils de Colmar
Hôpitaux Universitaires de Strasbourg

intervention_type: Biological

lead_sponsor_type: industriel


primary_purpose: Prevention

acronym: Immunogenicity and safety of different formulations of intramuscular swine-origin influenza vaccine

title: Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly Subjects

lead_sponsor: Sanofi Pasteur, a Sanofi Company

type: EudraCT Number

summary:
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.

Primary objectives:

To describe the immune response to study vaccine 21 days after each vaccination.
To describe the antibody persistence 8 months after the first vaccine administration using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects who received two injections.
To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza vaccine (TIV) administered 13 months after the first vaccination in a subset subjects who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin A/H1N1 strain.
To describe the safety profiles of study vaccines in all participants.


title: Inappropriate Medications and Alzheimer Disease: Prevalence and Associated Factors in Elderly Patients Treated With Anticholinesterase and/or Memantine. MIDA Study.

acronym: MIDA

summary: In each of the 7 French areas that should be involved, patients aged 75 years and over from three different sectors will be included: the geriatric consultation unit (60%) and two kinds of nursing homes, private (20%) and state (10%). Outpatients will be included in chronological order; patients in nursing homes will be included at random. The patients and their families will be asked about the treatments received on the day of inclusion. The inclusion period will extend over a year. The investigating practitioners will be asked to fill in a questionnaire reporting the main clinical data, adverse effects occurrence, and information on the treatment given.

study_type: Observational

time_perspective: Prospective

location_facility:
CHU Saint Etienne
CHU Montpellier
CHU Rouen
CHU Bordeaux
APHP Charles Foix
CH Le Mans


title: Immunogenicity of the Purified Vero Rabies Vaccine - Serum Free in Comparison With the Reference Purified Vero Rabies Vaccine in Pre-exposure Use in Healthy Adults

ReferenceType: result

ReferenceCitation: Pichon S, Guinet-Morlot F, Minutello M, Donazzolo Y, Rouzier R, Chassard D, Fitoussi S, Hou V. A serum-free, purified vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab for pre-exposure use in healthy adults: results from a randomized controlled phase-II trial. Vaccine. 2013 Apr 26;31(18):2295-301. doi: 10.1016/j.vaccine.2013.02.058. Epub 2013 Mar 16.

summary:
The purpose of this study is to generate data in human on immunogenicity and safety of Purified Vero Rabies Vaccine (VRVg) in support of the vaccine registration.

Primary Objective:

To demonstrate that VRVg is at least as immunogenic as the reference vaccine, Verorab, in terms of seroconversion rate at Day 42 of the primary vaccination series.

Secondary Objectives:

To assess the clinical safety of VRVg after each vaccination when administered in a pre-exposure vaccination schedule with a booster at 12 months after the first vaccination in all subjects.
To describe the immune response induced by VRVg 21 days after two vaccinations in a subset of randomized subjects and 14 days after the last vaccination of the primary vaccination series.


title: Neuroactive Steroids and Cognition in Humans: Pregnenolone Sulfate an Early Marker of the Memory Loss Associated With Alzheimer's Disease

acronym: STERMEM

summary: The steroid pregnenolone sulfate (PREGS) may be one of the factors responsible for the memory decline related to normal aging or associated with Alzheimer's disease (AD). The purpose of this study is to determine whether plasma levels of PREGS are decreased patients with at mild to moderate AD compared with AD-free control subjects matched for gender and age and to see whether they are inversely correlated with the severity of memory deficits in AD patients. The hypothesis is that blood levels of PREGS are decreased with advanced age and with the stage of AD that would be positively correlated with memory deficits. Therefore PREGS could be considered as an early marker of the memory deficits in AD.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique - Hôpitaux de Paris Hôpital Broca

location_facility: Assistance Publique - Hôpitaux de Paris, Hôpital Pitié-Salpétrière

location_facility: Assistance publique - Hôpitaux de Paris Hôpital Bicêtre

location_facility: Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse


title: Study of Predictive Proteomic Factors of the Response to Exclusive Concomitant Radiochemotherapy in Oesophageal Cancer

summary: The scope of the trial is to predict the early complete clinical response to exclusive concomitant radiochemotherapy in esophageal cancer by the study of the pre- and per- therapeutic proteomic profile.

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre François BACLESSE
CHU - Hopital Charles Nicolle
Centre Oscar Lambret
Centre Paul Papin
Centre Eugène Marquis
Centre Hospitalier Universitaire

intervention_type: Radiation


title: Impact of Clinical Follow-up and Therapeutic Education by Telemedicine in Chronic Heart Failure: a Randomized Multicenter Study.

acronym: SEDIC

summary: The purpose of the SEDIC study is to test a home based heart failure patient clinical follow-up and therapeutic education using telemedicine. This educational follow-up is based on an interactive information system (SCAD) including a touch screen personal computer for heart failure patient at home. An interactive algorithm has been developed to allow a self management teaching to the patient.Furthermore, a specialized nurse provide a clinical data follow-up.

lead_sponsor: University Hospital, Caen

location_facility:
Flers Hospital
Saint-Lo Hospital
Lisieux Hospital
Cherbourg Hospital
Caen University Hospital
Alençon-Mamers Hospital


title: A Phase II Open-label, Multicenter, Non Randomized Study Evaluating the Efficacy and the Safety of Clofarabine in Combination With IV Busulfan and Thymoglobulin (CBT) as a Reduced Intensity Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Adult Patients With High-risk AML, MDS or ALL.

acronym: Cloric

summary: Clofarabine is known to have a stronger anti-tumor effect than Fludarabine and has shown its efficacy in treating aggressive acute leukemias. In addition, evidence is that it is well-tolerated with manageable side effects especially in elderly patients. Thus, replacing Fludarabine with Clofarabine in a reduced intensity transplant regimen may provide a regimen with increased anti-tumor activity without adding significant risks of toxicity.The purpose of this study is to evaluate the efficacy and the safety of clofarabine in combination with IV busulfan and ATG as the backbone of a reduced intensity conditioning regimen for allogeneic stem cell transplantation for the treatment of patients with high-risk MDS/AML or ALL not eligible to conventional or standard myeloablative allo-SCT.

ReferenceCitation: Chevallier P, Labopin M, Socié G, Tabrizi R, Furst S, Lioure B, Guillaume T, Delaunay J, de La Tour RP, Vigouroux S, El-Cheikh J, Blaise D, Michallet M, Bilger K, Milpied N, Moreau P, Mohty M. Results from a clofarabine-busulfan-containing, reduced-toxicity conditioning regimen prior to allogeneic stem cell transplantation: the phase 2 prospective CLORIC trial. Haematologica. 2014 Sep;99(9):1486-91. doi: 10.3324/haematol.2014.108563. Epub 2014 Jun 20.

location_facility:
Hôpital Edouard Herriot
Institut Paoli Calmettes
Hôpital Saint Louis
CHU Haut-Lévêque
Nantes University hospital
CHRU Hautepierre


title: Impact of a Fermented Infant Formula in Weaning Babies

summary: When mothers wanted to shift from breast milk to infant formulae, babies were randomly assigned to receive a fermented or a standard formula. Biological and clinical investigations were achieved at baseline (V1), and after one (V2) and three months (V3) of consumption of study formula. Intestinal microbiota was assessed by using culture-dependent techniques.

lead_sponsor: Bledina

location_facility:
Cabinet médical
Hôpital saint Vincent de Paul
Cabinet medical

intervention_type: Other


title: Impact of the Hepatitis C Virus Variability on Liver Steatosis

acronym: Viro-steatosis

summary: Chronic infection by the hepatitis C virus (HCV) is a common cause of liver disease, which may progress to cirrhosis and eventually liver cancer. The therapeutic indication will depend mainly on the importance of liver damage (fibrosis), which can be assessed by physical techniques, blood tests and a liver biopsy. The overall objectives of the project are to understand how HCV variability may influence the severity of steatosis (accumulation of fat in the liver), studying 30 patients chronically infected with HCV (half of these patients infected by HCV genotype 3, versus the other half infected by HCV of another genotype). A small portion of the biopsy performed for the routine pathology examination will be placed in special fixation buffer for electron microscopy (EM). Counting and measuring the size of lipid droplets present in the liver by EM will be used to precisely quantify and characterize the liver steatosis. A blood sample of patients will also be collected to sequence the viral genome present in the patient and identify the amino acids involved in an increase in intracellular accumulation of lipid droplets. This work should clarify the impact of the viral variability in the severity of steatosis. Ultimately, the identification of viral sequences responsible for an increase of this phenomenon could be crucial for understanding the mechanisms involved in the steatosis.

lead_sponsor: University Hospital, Tours

location_facility:
CH de Châteauroux
CHR Orléans
CH de Blois
CH de Bourges
CHRU de Tours
CH de Dreux


acronym: FAKIR

title: Pharmaco Kinetic and Pharmacokinetic-Pharmacodynamic Variability of Infliximab

type: Other Identifier

ReferenceCitation: Ternant D, Ducourau E, Perdriger A, Corondan A, Le Goff B, Devauchelle-Pensec V, Solau-Gervais E, Watier H, Goupille P, Paintaud G, Mulleman D. Relationship between inflammation and infliximab pharmacokinetics in rheumatoid arthritis. Br J Clin Pharmacol. 2014 Jul;78(1):118-28. doi: 10.1111/bcp.12313.

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

summary:
Infliximab is a chimeric monoclonal antibody directed towards Tumor Necrosis Factor -alpha that is largely used in inflammatory diseases such as rheumatoid arthritis (RA).

A relationship between dose and clinical outcomes was shown in populations of RA patients but there is an interindividual variability of this relationship. At an individual level, this dose-effet relationship can be separated into the dose-concentration (pharmacokinetic or PK) and the concentration-effet (pharmacokinetic-pharmacodynamic or PK-PD) relationships.

Serum trough concentrations of infliximab have been shown to be variable between patients receiving the same treatment regimen. This PK variability may be explained by several factors (e.g. genetic and immunological factors). The concentration-effect relationship may also be variable and the sources of this variability need to be studied as well. To date no detailed infliximab PK analysis has been published. The sources of variability of the dose-effect relationship need to be characterized to optimize infliximab dosing regimen in patients.

The FAKIR study is a multicenter prospective observational study that will focus on patients treated with infliximab. Its aims are:

to characterize the PK and PK-PD variability of infliximab in RA, using clinical criteria and biomarkers, assessed over time ;
to study the influence of the polymorphism of FCGRT (the gene encoding FcRn) on the PK variability of infliximab; to study the influence of the polymorphism of FCGR3A (the gene encoding Fc gamma RIIIa) on the PK-PD variability of infliximab; and to study the influence of antibodies toward infliximab on the PK and PK-PD variabilities of infliximab.


title: Action of the Amantadine on Post Stroke Aphasic Patients' Language and Communication

summary: The objective of the study is to test the action of the amantadine, as DOPA-agonist, in a double blind cross-over trial, amantadine / placebo, on the verbal fluency of chronic post stroke aphasic patients.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
University hospital of Bordeaux
CH Saint Pierre La Réunion
CHU de Nice
CHU Rennes
CHU de Dijon
CHU Limoges


title: Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy in Patients With Uncertain Diagnosis Consulting for Clinical Symptoms Suggestive of Spondylarthropathy

acronym: EchoSpA

summary: The purpose of this study is to evaluate the interest of enthesis sonography for the diagnosis of spondylarthritis, in patients with uncertain diagnosis consulting for clinical symptoms suggestive of spondylarthritis

ReferenceCitation: Devauchelle-Pensec V, D'Agostino MA, Marion J, Lapierre M, Jousse-Joulin S, Colin D, Chary-Valckenaere I, Marcelli C, Loeuille D, Aegerter P, Guis S, Gaudin P, Breban M, Saraux A; Study Group of Spondylarthritis. Computed tomography scanning facilitates the diagnosis of sacroiliitis in patients with suspected spondylarthritis: results of a prospective multicenter French cohort study. Arthritis Rheum. 2012 May;64(5):1412-9. doi: 10.1002/art.33466.

ipd_sharing: No

lead_sponsor: Dr Maria-Atonietta D'AGOSTINO

location_facility:
Conception Hospital
South Hospital of Grenoble
Nancy Brabois Hospital
Cote de Nacre Hospital
Cavale Blanche Hospital
Ambroise Paré Hospital


title: Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery: a Multicenter, Randomized, Double-blind, Comparative Study

acronym: EVOLUTION

summary: The purpose of this study is to determine whether intraoperative goal-directed fluid management (with goal = cardiac stroke volume maximization) based on respiratory-induced pulse pressure variation monitoring may improve outcome after intrabdominal surgery

lead_sponsor: University Hospital, Lille

location_facility: Département d'Anesthésie-Réanimation, Hôpital Estaing, CHU


title: Chemotherapy With or Without Preventive Anticoagulation for Metastatic Cancer of the Pancreas

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

ReferenceCitation: Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12:CD008500. doi: 10.1002/14651858.CD008500.pub5.

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with chemotherapy. It is not yet known whether gemcitabine is more effective when given alone or together with dalteparin and/or capecitabine in treating patients with pancreatic cancer.

PURPOSE: This randomized phase III trial is studying whether dalteparin prevents blood clots in patients with pancreatic cancer receiving treatment with different combinations of gemcitabine and capecitabine.


acronym: NIMFEA

title: A Randomized Multicenter Phase II Study Identifying Hormone Sensitivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neo-adjuvant Treatment of Operable Breast Cancer in Postmenopausal Women.

lead_sponsor: UNICANCER

study_start_date_type: Actual

ReferenceCitation: Lerebours F, Rivera S, Mouret-Reynier MA, Alran S, Venat-Bouvet L, Kerbrat P, Salmon R, Becette V, Bourgier C, Cherel P, Boussion V, Balleyguier C, Thibault F, Lavau-Denes S, Nabholz JM, Sigal B, Trassard M, Mathieu MC, Martin AL, Lemonnier J, Mouret-Fourme E. Randomized phase 2 neoadjuvant trial evaluating anastrozole and fulvestrant efficacy for postmenopausal, estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients: Results of the UNICANCER CARMINA 02 French trial (UCBG 0609). Cancer. 2016 Oct;122(19):3032-40. doi: 10.1002/cncr.30143. Epub 2016 Jun 17.

ReferenceCitation: Lerebours F, Pulido M, Fourme E, Debled M, Becette V, Bonnefoi H, Rivera S, MacGrogan G, Mouret-Reynier MA, de Lara CT, Pierga JY, Breton-Callu C, Venat-Bouvet L, Mathoulin-Pélissier S, de la Motte Rouge T, Dalenc F, Sigal B, Bachelot T, Lemonnier J, Quenel-Tueux N. Predictive factors of 5-year relapse-free survival in HR+/HER2- breast cancer patients treated with neoadjuvant endocrine therapy: pooled analysis of two phase 2 trials. Br J Cancer. 2020 Mar;122(6):759-765. doi: 10.1038/s41416-020-0733-x. Epub 2020 Jan 31.

ReferenceCitation: Liang X, Briaux A, Becette V, Benoist C, Boulai A, Chemlali W, Schnitzler A, Baulande S, Rivera S, Mouret-Reynier MA, Bouvet LV, De La Motte Rouge T, Lemonnier J, Lerebours F, Callens C. Molecular profiling of hormone receptor-positive, HER2-negative breast cancers from patients treated with neoadjuvant endocrine therapy in the CARMINA 02 trial (UCBG-0609). J Hematol Oncol. 2018 Oct 11;11(1):124. doi: 10.1186/s13045-018-0670-9.

location_facility:
Centre Rene Huguenin
Centre Jean Perrin
Centre Eugene Marquis
Hopital Dupuytren
Institut Curie Hopital
Institut Gustave Roussy

summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy before surgery may be an effective treatment for breast cancer. It is not yet known whether anastrozole is more effective than fulvestrant when given before surgery in treating women with breast cancer.

PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal women with stage II or stage III breast cancer that can be removed by surgery.


title: Phase II Pilot Study Evaluating the Neoadjuvant Combination "Taxotere (Docetaxel) and Erbitux (Cetuximab) in Operable and "Triple Negative" Breast Cancer Patients. TENEO Study.

summary: The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination "Taxotere-Erbitux".

ReferenceCitation: Nabholtz JM, Chalabi N, Radosevic-Robin N, Dauplat MM, Mouret-Reynier MA, Van Praagh I, Servent V, Jacquin JP, Benmammar KE, Kullab S, Bahadoor MR, Kwiatkowski F, Cayre A, Abrial C, Durando X, Bignon YJ, Chollet P, Penault-Llorca F. Multicentric neoadjuvant pilot Phase II study of cetuximab combined with docetaxel in operable triple negative breast cancer. Int J Cancer. 2016 May 1;138(9):2274-80. doi: 10.1002/ijc.29952. Epub 2015 Dec 28.

lead_sponsor: Centre Jean Perrin

location_facility:
Hôpital Georges Pianta
Centre Hospitalier
Centre Jean Perrin
CHU Albert Michallon
Centre Oscar Lambret
Institut de Cancérologie de la LOIRE


title: Open-label, Dose-escalating, Phase I Study of TG4040 (MVA-HCV) in Treatment-naïve Patients Chronically Infected With Hepatitis C Virus (HCV Genotype 1)

summary:
The primary objective is to determine the safety of sub-cutaneous (SC) injections of TG4040 in non-cirrhotic, treatment-naïve patients chronically infected with HCV (genotype 1).

Patients will be sequentially treated at an escalting dose of TG4040. All patients will be followed up to at least 6 months after his/her first injection. In addition, all patients treated at the highest dose will receive a TG4040 boost injection 6 months after the first injection, and will be followed up during an additional 6-month period.

ReferenceCitation: Habersetzer F, Honnet G, Bain C, Maynard-Muet M, Leroy V, Zarski JP, Feray C, Baumert TF, Bronowicki JP, Doffoël M, Trépo C, Agathon D, Toh ML, Baudin M, Bonnefoy JY, Limacher JM, Inchauspé G. A poxvirus vaccine is safe, induces T-cell responses, and decreases viral load in patients with chronic hepatitis C. Gastroenterology. 2011 Sep;141(3):890-899.e1-4. doi: 10.1053/j.gastro.2011.06.009. Epub 2011 Jun 13.

location_facility:
Hôpital de Brabois
Hopital A. Michallon
Hopital Civil
Hôpital de l'Hôtel Dieu
Hopital de l'Hotel-Dieu
Hôpital Henri Mondor


title: Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

summary:
This is a prospective multicentric study including six clinical units of Gynecology and Obstetrics (5 public health hospital and one private team), one research team in clinical microbiology and one Center of Clinical investigation (CIC).

There is a correlation between premature delivery and bacterial vaginosis. So, the anomalies of vaginal flora are a potential target for the campaign against prematurity.

The main objective of this study is to achieve an objective and reproducible technique of identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies.

The secondary objectives are the exhaustive culture of bacteria, the characterisation of intermediate vaginal flora and bacterial vaginosis among pregnant woman by PCR targeting the ribosomic ADN 16S coupled with clonage techniques.

The number of patient to include is 1000 (time of inclusions: 24 months). The vaginal smears will be realized until 32 weeks of gestation (Max: 3 taking of vaginal smears by patient).

ReferenceCitation: Bretelle F, Rozenberg P, Pascal A, Favre R, Bohec C, Loundou A, Senat MV, Aissi G, Lesavre N, Brunet J, Heckenroth H, Luton D, Raoult D, Fenollar F; Groupe de Recherche en Obstetrique Gynecologie. High Atopobium vaginae and Gardnerella vaginalis vaginal loads are associated with preterm birth. Clin Infect Dis. 2015 Mar 15;60(6):860-7. doi: 10.1093/cid/ciu966. Epub 2014 Dec 1.

ReferenceCitation: Menard JP, Fenollar F, Raoult D, Boubli L, Bretelle F. Self-collected vaginal swabs for the quantitative real-time polymerase chain reaction assay of Atopobium vaginae and Gardnerella vaginalis and the diagnosis of bacterial vaginosis. Eur J Clin Microbiol Infect Dis. 2012 Apr;31(4):513-8. doi: 10.1007/s10096-011-1341-8. Epub 2011 Jul 26.

ReferenceCitation: Menard JP, Mazouni C, Salem-Cherif I, Fenollar F, Raoult D, Boubli L, Gamerre M, Bretelle F. High vaginal concentrations of Atopobium vaginae and Gardnerella vaginalis in women undergoing preterm labor. Obstet Gynecol. 2010 Jan;115(1):134-140. doi: 10.1097/AOG.0b013e3181c391d7.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility:
CHU Antoine BECLERE
Centre médicochirurgical et obstétrical
Centre Hospitalier Poissy-Saint-Germain
Hôpital Saint Joseph
Hôpital Nord-OB/GYN Department
Hôpital de la Conception

intervention_type: Procedure


title: Clinical Trial of the Neoadjuvant Standard Chemotherapy 3 FEC 100 + 3 TAXOTERE Protocol Versus the Same Protocol Adapted as a Function of Clinical Response

summary:
Neoadjuvant chemotherapy, known as "first" or "induction chemotherapy" in the therapeutic assumption of breast cancer is based on the narrow dependence preclinically revealed between primary tumour, tumoral angiogenesis and growth of distant metastases.

The results of the Aberdeen Group (Smith et al, 2002 ; Hutcheon et al, 2003), of the NSABP B27 trial (Bear et al, 2003) and of the Gepar-Duo Group (Von Minckwitz et al, 2002) have shown that a sequential protocol, using docetaxel after an anthracycline-based combination, allowed a better clinical response leading to more frequent conservative surgeries and, more importantly, to an increase in the rate of complete pathological response, assessing a better efficacy.

The use of a reference adjuvant protocol as a neo-adjuvant treatment is fully admissible because 7 randomized trials have shown a perfect equivalence between an adjuvant protocol and the same chemotherapy given as an induction treatment Even keeping the principle of a sequential treatment, a crucial question is to know if this sequential treatment should be the same for all patients, or if the oncologist could get a better complete pathological response, disease-free or overall survival rates by an adaptation of treatment to the objective result beginning after 2 FEC 100 courses by modulation of the following courses.

We will use as a primary regimen 3 FEC cycles + 3 TAXOTERE cycles, a standard adjuvant regimen (noted in the Temporary Protocol of Treatment of the Inca page 5 (October 2005) as well as in Saint Paul de Vence 2005 recommendations for adjuvant chemotherapy (Oncologie -- volume 7 - N°5, August 2005, p 370). This standard treatment will be compared to the same chemotherapy modulated in its repartition according to results obtained by subsequent tumor evaluations during induction therapy.

ReferenceCitation: Roché H, Fumoleau P, Spielman M et al. Breast Cancer Res Treat. 2004;88(suppl1):S16. Abstract 27

ReferenceCitation: Mouret-Reynier MA, Abrial CJ, Ferrière JP, Amat S, Curé HD, Kwiatkowski FG, Feillel VA, Lebouëdec G, Penault-Llorca FM, Chollet PJ. Neoadjuvant FEC 100 for operable breast cancer: eight-year experience at Centre Jean Perrin. Clin Breast Cancer. 2004 Oct;5(4):303-7.

ReferenceCitation: Wang-Lopez Q, Mouret-Reynier MA, Savoye AM, Abrial C, Kwiatkowski F, Garbar C, DuBray-Longeras P, Eymard JC, Lebouedec G, Vanpraagh I, Penault-Llorca F, Chollet P, Cure H. Is it important to adapt neoadjuvant chemotherapy to the visible clinical response? An open randomized phase II study comparing response-guided and standard treatments in HER2-negative operable breast cancer. Oncologist. 2015 Mar;20(3):243-4. doi: 10.1634/theoncologist.2014-0400. Epub 2015 Jan 30.

location_facility:
Institut Jean Godinot
Centre Jean Perrin
Institut de Cancérologie de la Loire
Edouard Herriot University Hospital
University Hospital La Tronche
Hospital center


title: Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by the Index Bispectral: Comparison Between Manual Perfusion and Automated Perfusion

summary: To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during anesthesia

ReferenceCitation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloë PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95.

ReferenceCitation: Liu N, Chazot T, Trillat B, Pirracchio R, Law-Koune JD, Barvais L, Fischler M. Feasibility of closed-loop titration of propofol guided by the Bispectral Index for general anaesthesia induction: a prospective randomized study. Eur J Anaesthesiol. 2006 Jun;23(6):465-9.

lead_sponsor: Hopital Foch

location_facility: Dept of Anesthesia, Clinique Saint Augustin

location_facility: Dept of Anesthesia and Intensive Care, Hôpital Beaujon


title: A Network to Control Risk Factors After Acute Coronary Syndrome

summary: The purpose of this study is to determine whether the follow up of patients with acute coronary syndrome and modifiable cardiovascular risk factors is efficient based on outpatients visits in a House of Education, underlining the importance of nicotinic weaning, weight loss and physical activity practice.

ReferenceCitation: Cohen A, Assyag P, Boyer-Chatenet L, Cohen-Solal A, Perdrix C, Dalichampt M, Michel PL, Montalescot G, Ravaud P, Steg PG, Boutron I; Réseau Insuffisance Cardiaque (RESICARD) PREVENTION Investigators. An education program for risk factor management after an acute coronary syndrome: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):40-8. doi: 10.1001/jamainternmed.2013.11342.

lead_sponsor: Resicard

location_facility:
Hopital Bichat
Hopital Lariboisiere
Hopital Saint Antoine
Clinique la Roseraie
Hopital Pitie Salpetriere
Hopital Tenon

intervention_type: Behavioral


title: A Phase IV, One-arm, Open-label, Multicenter Study Evaluating Effect of Treatment Change to Atazanavir/Ritonavir on Brachial Endothelial Function of HIV Infected Patient Receiving Function in HIV Infected Patient Receiving Potent Antiretroviral Combination Therapy

summary: The purpose of this clinical research study is to learn if BMS-232632 administered as Atazanavir/ritonavir (ATV/RTV) is superior to an anti-retroviral regimen including Lopinavir/ritonavir (LPV/RTV), as assessed by an increased brachial artery flow-mediated vasodilatation (FMD), in HIV-infected patients. The safety of this treatment will also be studied.

lead_sponsor: Bristol-Myers Squibb


title: Oral Vinorelbine and Cisplatin and Concurrent Radiotherapy After Induction Chemotherapy With Cisplatin-docetaxel in Patients With Locally Advanced Non-small-cell Lung Cancer. A Multicenter Phase II Trial

acronym: VINCR

summary:
Our aim is to conducted a multicenter phase II trial of the cisplatin-oral vinorelbine -radiotherapy combination after induction chemotherapy with cisplatin-docetaxel in patient with NSCLC. Oral vinorelbine will be used in the present study rather than the intravenous form because: 1- Previous investigations have demonstrated that oral vinorelbine is as effective as the intravenous form in the treatment of NSCLC. 2 - We think that the use of oral agents in CT will reduce some disagreements provoked by intravenous injections: stress, infections, hemorrhage, displacement at the hospital and cost of CT.

.

ReferenceCitation: Fournel P, Robinet G, Thomas P, Souquet PJ, Léna H, Vergnenégre A, Delhoume JY, Le Treut J, Silvani JA, Dansin E, Bozonnat MC, Daurés JP, Mornex F, Pérol M; Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Français de Pneumo-Cancérologie. Randomized phase III trial of sequential chemoradiotherapy compared with concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer: Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Français de Pneumo-Cancérologie NPC 95-01 Study. J Clin Oncol. 2005 Sep 1;23(25):5910-7. Epub 2005 Aug 8.

ReferenceCitation: Vergnenègre A, Daniel C, Léna H, Fournel P, Kleisbauer JP, Le Caer H, Letreut J, Paillotin D, Pérol M, Bouchaert E, Preux PM, Robinet G; Groupe Francais de Pneumo-Cancerologie. Docetaxel and concurrent radiotherapy after two cycles of induction chemotherapy with cisplatin and vinorelbine in patients with locally advanced non-small-cell lung cancer. A phase II trial conducted by the Groupe Francais de Pneumo-Cancerologie (GFPC). Lung Cancer. 2005 Mar;47(3):395-404.

lead_sponsor: University Hospital, Brest

location_facility:
CH GAP
Hopital de la Croix Rousse
CHU Hôpital Nord
CHU de LIMOGES
CHU of Brest
Hôpital Sainte Margueritte


title: Study of the Relationship Between the Rate of Residual Platinum in the Blood and the Incidence of Persistent Neurotoxicity in Patients Treated for Gastrointestinal Cancer With Oxaliplatin

summary:
RATIONALE: Learning about the relationship between platinum levels in the blood and neurotoxicity in patients receiving oxaliplatin may help plan treatment and may help patients live more comfortably.

PURPOSE: This phase IV trial is studying the relationship between platinum levels in the blood and neurotoxicity in patients who are receiving oxaliplatin for gastrointestinal cancer.

status: Unknown status

location_facility: Centre Hospital Universitaire Hop Huriez


title: Take Evaluation and Safety of Smallpox Vaccine (LISTER Strain) in Naïve Healthy Adults.

summary:
Primary Objective:

To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine.

Secondary Objectives:

To describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate local signs, symptoms, and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.

lead_sponsor: Sanofi


title: A Phase II Trial of Adjuvant Treatment With Gemcitabine and Oxaliplatin Followed by Concomitant Gemcitabine and Radiation Therapy in Patients With Resected Pancreatic Adenocarcinoma

summary: A non-randomized phase II study to determine the efficacy and safety of the combination of Gemcitabine and Oxaliplatin followed by Gemcitabine and radiotherapy in patients with surgically resected pancreatic cancer.

lead_sponsor: Eli Lilly and Company

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


title: Growth Hormone Treatment of Young Adults Deficient in Growth Hormone Since Childhood : Study of Body Composition Modifications.

summary:
Hypopituitary adults with all the hormonal deficiencies are well subsituted excepted for the growth hormone (GH) and died earlier than the rest of the population. GH deficiency involves a fat mass increase with regard to lean mass, an atherogenic lipidic profile and participating to osteopenia mechanism and decrease the life quality. All these dysfunctions are partially or totally corrected by the GH prescription with patient deficient since adulthood.

However, for patients deficient since childhood, no study have demonstrated that GH treatment during childhood present these same benefit when they are treated during adulthood.

Primary objective of this study is to examine that fat mass significantly decrease due to GH treatment in adulthood for patient GH deficient since childhood, treated by GH during childhood but stopped since the end of adolescence.

We compare the body composition and others energetic metabolism parameters in two patient groups, one treated by GH during 18 months, and the other with no treatment. Body composition and bone density are measured by pletysmography (DEXA). Metabolic parameters are : energetic balance (energy intake evaluation by questionnaire, energetic expenditure evaluated by doubly labelled water) and biologic parameters (lipidic profile, thyroid hormones).

This study will evaluate if the GH treatment of young GH deficient adults since childhood can be a benefit for body composition, lipidic profile and bone density.

lead_sponsor: University Hospital, Angers

location_facility:
UH of Brest
UH of Rennes
UH of Angers
UH of Caen
UH of Limoges
UH of Tours


title: Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women

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

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.

location_facility:
Polyclinique De Courlancy
Centre Medico-Chirurgical Foch
C.H. Senlis
Hopital Saint Antoine
Hopital Tenon
Centre Hospitalier Victor Dupouy


title: Combination Chemotherapy Concurrent With Postoperative Radiotherapy Epidermoid Carcinoma of the Head and Neck at High Risk of Recurrence - Study of Feasibility

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have head and neck cancer.

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours


title: Thromboembolic Risk Screening in Patients With Cancer and COVID-19

acronym: NEOTHROCOVID

summary:
Study Rational

Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. First data report high mortality in severe patients with 30% death rate at 28 days. Exact proportions of the reasons of death are unclear: severe respiratory distress syndrome is mainly reported which can be related to massive cell destruction by the virus, bacterial surinfection, cardiomyopathy or pulmonary embolism. The exact proportion of all these causes is unknown and venous thromboembolism could be a major cause because of the massive inflammation reported during COVID-19.

High levels of D-dimers and fibrin degradation products are associated with increased risk of mortality and some authors suggest a possible occurrence of venous thromboembolism (VTE) during COVID-19.

Indeed, COVID-19 infected patients are likely at increased risk of VTE. In a multicenter retrospective cohort study from China, elevated D-dimers levels (>1g/L) were strongly associated with in-hospital death, even after multivariable adjustment.

Also, interestingly,the prophylactic administration of anticoagulant treatment was associated with decreased mortality in a cohort of 449 patients, with a positive effect in patients with coagulopathy (sepsis-induced coagulopathy score ≥ 4) reducing the 28 days mortality rate (32.8% versus 52.4%, p=0.01).

However the presence/prevalence of VTE disease is unknown in COVID-19 cancer patients with either mild or severe disease. Cancer patients are at a higher risk of VTE than general population (x6 times) and could be consequently at a further higher of VTE during COVID-19, in comparison with non-cancer patients.

The exact rate of VTE and pulmonary embolism during COVID-19 was never evaluated, especially in cancer patients, and is of importance in order to understand if this disease needs appropriate prophylaxis against VTE.

The largest series of cancer patients so far included 28 COVID-19 infected cancer patients: the rate of mortality was 28.6%. 78.6% of them needed oxygen therapy, 35.7% of them mechanical ventilation. Pulmonary embolism was suspected in some patients but not investigated due to the severity of the disease and renal insufficiency, reflecting the lack of data in this situation.

The aim of the present study is to analyze the rate of symptomatic/occult VTE in a cohort of patients with cancer.

Expected benefits Anticipated benefits of the research are the detection of VTE in order to treat it for the included patient.

For all COVID-19 positive cancer patients it will enable to provide some guidelines and determine which patient are at risk for VTE and which will need ultrasound to detect occult VTE.

Foreseeable risks Foreseeable risks for patients are non-significant because the additional procedures needed are ultrasound exam, and blood sample test.

Methodology

Retrospective and prospective (ambispective), multicentric study to evaluate the occurrence of venous thromboembolism during COVID-19 infection.

Indeed, because the outbreak can end within the next 3-6 months, Investigators may not be able to answer the question if Investigators only focus on patients investigated prospectively. Investigators then decided to include patients from medical team who are already systemically screening patients with COVID-19 disease for VTE.

Trial objectives

Main objective To evaluate the rate of venous thromboembolism at 23 days during COVID-19 infection in cancer patients.

primary_purpose: Screening

lead_sponsor: Centre Antoine Lacassagne

location_country: France Monaco

location_facility:
CHPG
Centre Azuréen de Cancérologie
Centre Antoine Lacassagne
Clinique Saint-Georges
Clinique Saint-Jean
CHU Nice

intervention_type: Diagnostic Test


title: Observational, Multicentre, Investigator and Patient Blinded, Prospective, Randomized Comparator Study of Cardiac Resynchronization Therapy (CRT) Multi Point Pacing (MPP) Compared to Conventional CRT Pacing Response in Heart Failure Patients.

acronym: CRT-MPP

summary: The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy

study_start_date_type: Anticipated

status: Withdrawn

primary_purpose: Other

lead_sponsor: CMC Ambroise Paré

location_facility:
CMC Ambroise Paré
PHc hôpital d'Antibes la Fontonne
Centre Hospitalier de Perpignan
Centre Hospitalier Princesse Grace
Centre hospitalier de Cannes
CHU Nice


title: Immune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular Diseases

acronym: ISLE

summary:
Accelerated atherosclerosis is an established complication of systemic autoimmune diseases, particularly SLE. Young female patients with SLE are more likely to develop myocardial infarction than matched healthy controls, and CVD is nowadays one of the most common causes of death (27%) in lupus patients. While traditional CV risk factors cannot explain such increased CV morbidity associated with SLE, common disease factors shared between SLE, atherosclerosis and treatment exposure may be of outmost importance in this process. Our group made 3 findings of particular interest that could link SLE pathogenesis and atherosclerosis-associated immune dysregulation: 1/ the investigators identified specific immunometabolites (circulating nucleotide-derived metabolites adenine and N4-acetylcytidine), which are increased in the circulation of SLE patients. These immunometabolites trigger a constitutive inflammasome activation resulting in aberrant IL1-β production. Given that IL1-β inhibition was reported to significantly reduce CV events without altering lipid levels, the investigators propose that these immunometabolites may represent novel candidate biomarkers of CV risk stratification in SLE. 2/ the investigators identified OX40L as an important costimulatory molecule implicated in follicular helper T cell (Tfh) activation in SLE. Interestingly, OX40L polymorphism has been associated to both SLE and atherosclerosis, and Tfh have been recently shown to accelerate atherosclerosis progression. 3/ Immune complexes-activated platelets sustain aberrant immune response in SLE and block immunosuppressive functions of regulatory T cells (Tregs) in a P-selectin/PSGL1 dependent manner. Selectins and Tregs cell dysfunction are well accepted players in atherosclerosis pathogenesis.

Thus there are multiple pathways that are shared between SLE and atherosclerosis and that may results in an increased risk of CV-associated morbidity in SLE patients. Exploring these interconnected pathways in SLE patients together with traditional and other well-established disease-related factors, might lead to a better stratification of CV risk in SLE.

The aim of this study is to investigate the accuracy, predictive value and utility of immunological disease-related biomarkers in stratifying CV risk in patients with SLE.

status: Recruiting

lead_sponsor: University Hospital, Bordeaux

location_country: Germany France

location_facility: AP-HP - Hôpital Cochin - service de Médecine Interne

location_facility: CHRU de Lille - service de Médecine Interne

location_facility: CHU de Bordeaux - service de médecine interne

location_facility: CHU de Strasbourg - service d'Immunologie Clinique

status_simplified: Ongoing


title: A 3-month Randomized Double Blind Placebo-controlled Multicenter Study to Assess the Efficacy of STABLOR® on Visceral Fat Mass Reduction in Patients With Metabolic Syndrome

summary: The primary objective of the study is to assess the efficacy of STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome during 12 weeks of consumption.

lead_sponsor: LNC THERAPEUTICS

location_country: France Ireland

location_facility:
Institut Pasteur de Lille
CIC Pitié Salpêtrière
CEN Experimental
Biofortis
Atlantia Food Clinical Trials
Eurofins Optimed

intervention_type: Dietary Supplement


title: Randomized Phase III Study Comparing an Adjuvant Chemotherapy With Fotemustin to Intensive Surveillance in Patients With High Risk Uveal Melanoma

acronym: FOTEADJ

summary:
After the local treatment of the primary tumor (protonbeam-therapy, enucleation, external radiotherapy) patients with high risk of metastasis are randomized between:

Adjuvant chemotherapy with Fotemustin.
Observation

Both groups are followed during 3 years for Metastasis- Free Survival, safety and tolerance of Fotemustin, quality of life, and Overall Survival.

lead_sponsor: Institut Curie

location_country: France Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois


title: Diagnostic Performance of a New Bio-marker During Bacterial Sepsis

acronym: BACTIDIAG

summary:
Sepsis is a constant concern in ICU, frequent and severe, it requires early diagnosis and prompt implementation of the etiological treatment. The bacterial infections are the most common and are associated with high morbidity and mortality. Diagnosis is based on the detection of micro-organisms (bacteria) that can confirm the diagnosis and to tailor antibiotic treatments. Blood cultures are positive in 30-35% of cases and diagnosis is often based on a body of evidence that the use of biomarkers. No biomarkers (or even a combination of biomarkers) no evidence to confirm or refute the diagnosis of sepsis alone. During sepsis, gram + and gram - are circulating and often present in small amounts; they can be detected by sensitive and specific tools following a pretreatment of the blood sample (innovative technology Bacti-DIAG).

The main objective of the multicentre study Bacti-DIAG-Rea is testing in prospectively, in a suspicious population resuscitation of sepsis, this new bacterial biomarker. Secondary objectives will assess whether Bacti-DIAG provides time and precision gain (gram + vs grams) in the patient's care including diagnosis and treatment.

All ICU patients and with clinical criteria of Systemic Inflammatory Response Syndrome (SIRS) sepsis suspects will be included: in addition to the samples taken for routine care of the patient 4 tubes of whole blood will be collected 5mL. The definitive diagnosis of sepsis or SIRS be confirmed retrospectively by two independent experts blinded to Bacti-DIAG. The areas under the ROC curves for the detection of gram + and gram will be calculated and associated detection limits will be determined to meet the objectives of the study.

It is planned to include 400 consecutive patients with SIRS criteria for sepsis 300-360 and analyze biometric and biological data based on the subsequent evolution of the patients. The care of patients will be blinded to the results of the new biomarker Bacti-DIAG

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Antibes hospital Center
Monaco princesse grace Hospital
CHU de Nice
Cannes Hospital
Frejus Hospital
Draguignan Hospital


title: INTERNATIONAL STUDY of Chronic Myeloid Leukaemia (CML) Treatment and Outcomes in Children and Adolescents

acronym: ICMLPed

summary: The purpose of the study is to describe and characterize CML in a large pediatric cohort of patients.

ReferenceCitation: Meyran D, Petit A, Guilhot J, Suttorp M, Sedlacek P, De Bont E, Li CK, Kalwak K, Lausen B, Culic S, de Moerloose B, Biondi A, Millot F. Lymphoblastic predominance of blastic phase in children with chronic myeloid leukaemia treated with imatinib: A report from the I-CML-Ped Study. Eur J Cancer. 2020 Sep;137:224-234. doi: 10.1016/j.ejca.2020.06.024. Epub 2020 Aug 13.

ReferenceCitation: Millot F, Maledon N, Guilhot J, Güneş AM, Kalwak K, Suttorp M. Favourable outcome of de novo advanced phases of childhood chronic myeloid leukaemia. Eur J Cancer. 2019 Jul;115:17-23. doi: 10.1016/j.ejca.2019.03.020. Epub 2019 May 10.

ReferenceCitation: Millot F, Guilhot J, Suttorp M, Güneş AM, Sedlacek P, De Bont E, Li CK, Kalwak K, Lausen B, Culic S, Dworzak M, Kaiserova E, De Moerloose B, Roula F, Biondi A, Baruchel A. Prognostic discrimination based on the EUTOS long-term survival score within the International Registry for Chronic Myeloid Leukemia in children and adolescents. Haematologica. 2017 Oct;102(10):1704-1708. doi: 10.3324/haematol.2017.170035. Epub 2017 Aug 24.

lead_sponsor: Poitiers University Hospital

location_country: Croatia Spain Belgium Japan Czechia Poland Austria Australia Argentina Turkey Slovakia Brazil Lebanon China Germany Denmark Belarus Greece France Chile Netherlands

location_facility: National Research Center for Pediatric Oncology and Hematology

location_facility: Saint George Hospital University Medical Centre


type: Other Grant/Funding Number

title: Long-term, Prospective Study Evaluating Clinical and Molecular Biomarkers of Epileptogenesis in a Genetic Model of Epilepsy - Tuberous Sclerosis Complex

acronym: EPISTOP

summary:
The primary objective of clinical part of EPISTOP project is to identify the clinical and molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC.

Secondary objective of the clinical part of EPISTOP is to compare the effects of standard antiepileptic treatment in patients diagnosed as having epilepsy after clinical seizures vs after electroencephalographic epileptiform discharges, in a randomized trial in TSC patients.

ReferenceCitation: van der Poest Clement E, Jansen FE, Braun KPJ, Peters JM. Update on Drug Management of Refractory Epilepsy in Tuberous Sclerosis Complex. Paediatr Drugs. 2020 Feb;22(1):73-84. doi: 10.1007/s40272-019-00376-0. Review.

lead_sponsor: Sergiusz Jozwiak

location_country:
Poland
Italy
Austria
Netherlands
Czech Republic
France
Belgium
Germany

location_facility: Universita Degli Studi Di Roma Tor Vergata

location_facility: Institut National De La Sante et de la Recherche Medicale


title: A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients

acronym: COPERNIC

summary:
COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC subjects who meet all eligibility criteria will be treated with standard systemic chemotherapy (the decision about the treatment regimen being made by the treating physician) and undergo tumour assessment by standard imaging (either CT scan or MRI scan) at baseline and every 8 or 12 weeks until evidence of tumour progression. Response to treatment will be assessed by the local investigators according to the RECIST criteria version 1.1. Blinded, independent central review of the imaging scan will be carried out, this having no impact on treatment decisions thatwhich will remain the prerogative of the treating physician.

Serial blood samples from study subjects will be collected at pre-defined time points for ctDNA testing. Also, archived tumour tissue from each subject will be collected. Prospective and retrospective ctDNA analyses on blood samples will be carried out, and dynamics of ctDNA will be correlated with treatment outcomes prognosis.

status: Not yet recruiting

lead_sponsor: Jules Bordet Institute

location_country: France Belgium

location_facility:
Centre Georges François Leclerc
ICO
Hopital St-Louis
CHU Poitiers
ICANS Strasbourg
Institut Jules Bordet


title: Exception Cementless Femoral Stem in Total Hip Arthroplasty. A Multicenter, Retrospective and Prospective, Non-controlled Post Market Clinical Follow-up Study (Implants and Instrumentation)

acronym: Exception

summary: This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, performance and clinical benefits the Exception Cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.

time_perspective: Other

lead_sponsor: Zimmer Biomet

location_facility:
Hôpital Princesse Paola
Clinique Basseres Kacem-Boudhar
CH Annecy Genevois
Hopital Renee Sabran
CH Alpes Léman
Hôpitaux Du Léman


title: Intérêt de la règle CARE Pour Exclure l'hypothèse d'un Syndrome Coronarien Aigu Sans Dosage Biologique - ICARE

acronym: ICARE

summary:
Acute coronary syndrome (ACS) is a major health problem and its diagnosis remains a challenge for the emergency physician. The management of a suspected ACS is well codified, based on troponin assays, renewed if necessary.

Conversely, the criteria leading to initiate a diagnostic procedure in chest pain to the Emergency department are unclear. The fear is, firstly, to miss a potentially life treating diagnosis and, secondly, exposing many patients to unnecessary examinations. The advent of highly sensitive troponin assays also increases the risk of over-investigation by a larger number of elevations of the biomarker in non-coronary circumstances leading to a prolongation of hospitalization and, possibly, unnecessary treatments and invasive investigations.

CARE rule could help to streamline this first step. It is established by assigning a value from 0 to 2 to the items: Characteristic of pain, Age, Risk factors and ECG. The search for an ACS is not justified if the sum of points is ≤1 (negative rule) and, conversely, a troponin should be performed if the sum is > 1 (positive rule).

Indeed, CARE rule corresponds to the first 4 items of the HEART score (the latter standing for troponin at admission) whose reliability has been demonstrated, a ≤3 income excluding ACS with a risk of false negatives <2%. A negative CARE rule always corresponds to a HEART score ≤3.

Our study aims to confirm the interest of CARE rule to streamline the search for an ACS in chest pain as an observational European multicenter prospective study.

ReferenceCitation: Moumneh T, Penaloza A, Cismas A, Charpentier S, Schotté T, Pernet S, Malatest S, Prunier F, Warnant A, Mezdad TH, Gangloff C, Soulat L, Douillet D, Riou J, Roy PM. Evaluation of HEAR score to rule-out major adverse cardiac events without troponin test in patients presenting to the emergency department with chest pain. Eur J Emerg Med. 2021 Aug 1;28(4):292-298. doi: 10.1097/MEJ.0000000000000791.

location_facility:
University Hospital Toulouse
Hospital of Cholet
Hospital of Saint-Malo
SCHOTTE Thibault
University Hospital Angers
Cliniques Universitaires Saint-Luc


title: A Proof of Concept Study to Investigate the Effect of T4P1001 Treatment in Patients With Peripheral Neuropathic Pain or Osteoarthritic Pain of Knee or Hip

summary: The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response

primary_purpose: Basic Science

location_facility: CIC Clermont-Ferrand, CHU Clermont-Ferrand

location_facility: Centre d'Evaluation et Traitement de la Douleur, CHU Saint-Etienne


ipd_sharing: Yes

acronym: FLU D-QIV-010 PRI

title: Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine 2014/2015 Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) When Co-administered With Pneumovax™ 23 in Adults 50 Years of Age and Older

lead_sponsor: GlaxoSmithKline

ReferenceCitation: Ofori-Anyinam O, Leroux-Roels G, Drame M, Aerssens A, Maes C, Amanullah A, Schuind A, Li P, Jain VK, Innis BL. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine co-administered with a 23-valent pneumococcal polysaccharide vaccine versus separate administration, in adults ≥50years of age: Results from a phase III, randomized, non-inferiority trial. Vaccine. 2017 Nov 1;35(46):6321-6328. doi: 10.1016/j.vaccine.2017.09.012. Epub 2017 Oct 5.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

summary: The purpose of this study is to investigate the immunogenicity and safety when GSK Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with Merck & Co. Inc.'s pneumococcal vaccine (Pneumovax™23/Pneumovax) in adults 50 years of age and older at risk for complications from influenza and pneumococcal infections.


title: A Phase 1 / 2 Study of CAN04, a Fully Humanized Monoclonal Antibody Against IL1RAP, in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumours

summary: This is a Phase 1/2, open-label, multicentric, non-randomised, parallel-arm study that aims to establish the safety, tolerability, and initial efficacy of CAN04 in combination with 3 SoC chemotherapies (mFOLFOX, DTX, and G/C).

status: Active, not recruiting

lead_sponsor: Cantargia AB

location_country: France Spain

location_facility: EDOG Institut de Cancerologie de l'Ouest - PPDS


title: Cross-validation of the Finger Prick Dried Blood Spot Assay Method With the Established Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients

summary: The principal aim of this study is to define the relationship between tacrolimus concentrations determined from the finger prick DBS (Dry Blood Spot) method and those determined from blood samples collected by venepuncture in transplant recipients.

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
France
United Kingdom

location_facility:
Site: 7
Site: 3
Site: 6
Site: 1
Site: 2
Site: 5


summary: This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic shoulder osteoarthritis (OA). Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 month follow up period.

lead_sponsor: Genzyme, a Sanofi Company

location_facility: Centre de Medecine et Traumatologie du Sport Clinique du Sport

location_facility: Universitatsklinik und Poliklinik Orthopadie & Physikalische Medizin


title: A Phase II Randomized, Blinded, Dose-Ranging Multicenter Study to Evaluate the Safety and Efficacy of Different Regimens of 1592U89 Monotherapy Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy-Naive Patients

summary: The purpose of this study is to see if giving 1592U89 to HIV-infected patients is safe and effective in lowering viral load (level of HIV in the blood) and raising the level of CD4 cells (cells of the body that help fight infection).

ReferenceCitation: Staszewski S, Katlama C, Harrer T, Massip P, Yeni P, Cutrell A, Tortell SM, Harrigan RP, Steel H, Lanier RE, Pearce G. A dose-ranging study to evaluate the safety and efficacy of abacavir alone or in combination with zidovudine and lamivudine in antiretroviral treatment-naive subjects. AIDS. 1998 Nov 12;12(16):F197-202.

lead_sponsor: Glaxo Wellcome

location_facility: Hopital de Purpan / Service du Professeur Auvergnat

location_facility: Group Hospier Pitie-Salpetriere / Maladies Infec et Trop

location_facility: Hopital de Purpan / CHU de Rangueil / Medecine Interue

location_facility: Groupe Hospitalier Bichat-Claude Bernard


title: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence: an Open-label Randomized Controlled Trial: TRAPIST - TRAP Intervention STudy

acronym: TRAPIST

summary: Multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women diagnosed with TRAP sequence diagnosed between 12.0 and 13.6 weeks to an early or late intervention group (1:1), using a web-based application and a computer-generated list with random permuted blocks of sizes 2 or 4 (www.sealedenvelope.com), stratified by gestational age (GA) at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by intention to treat.

ReferenceCitation: Moore TR, Gale S, Benirschke K. Perinatal outcome of forty-nine pregnancies complicated by acardiac twinning. Am J Obstet Gynecol. 1990 Sep;163(3):907-12.

ReferenceCitation: Pagani G, D'Antonio F, Khalil A, Papageorghiou A, Bhide A, Thilaganathan B. Intrafetal laser treatment for twin reversed arterial perfusion sequence: cohort study and meta-analysis. Ultrasound Obstet Gynecol. 2013 Jul;42(1):6-14. doi: 10.1002/uog.12495. Review.

ReferenceCitation: Hecher K, Lewi L, Gratacos E, Huber A, Ville Y, Deprest J. Twin reversed arterial perfusion: fetoscopic laser coagulation of placental anastomoses or the umbilical cord. Ultrasound Obstet Gynecol. 2006 Oct;28(5):688-91.

ReferenceCitation: Chaveeva P, Poon LC, Sotiriadis A, Kosinski P, Nicolaides KH. Optimal method and timing of intrauterine intervention in twin reversed arterial perfusion sequence: case study and meta-analysis. Fetal Diagn Ther. 2014;35(4):267-79. doi: 10.1159/000358593. Epub 2014 Apr 16.

ReferenceCitation: Lewi L, Valencia C, Gonzalez E, Deprest J, Nicolaides KH. The outcome of twin reversed arterial perfusion sequence diagnosed in the first trimester. Am J Obstet Gynecol. 2010 Sep;203(3):213.e1-4. doi: 10.1016/j.ajog.2010.04.018. Epub 2010 Jun 3.

ReferenceCitation: O'Donoghue K, Barigye O, Pasquini L, Chappell L, Wimalasundera RC, Fisk NM. Interstitial laser therapy for fetal reduction in monochorionic multiple pregnancy: loss rate and association with aplasia cutis congenita. Prenat Diagn. 2008 Jun;28(6):535-43. doi: 10.1002/pd.2025.

ReferenceCitation: Scheier M, Molina FS. Outcome of twin reversed arterial perfusion sequence following treatment with interstitial laser: a retrospective study. Fetal Diagn Ther. 2012;31(1):35-41. doi: 10.1159/000334156. Epub 2011 Dec 23.

ReferenceCitation: Berg C, Holst D, Mallmann MR, Gottschalk I, Gembruch U, Geipel A. Early vs late intervention in twin reversed arterial perfusion sequence. Ultrasound Obstet Gynecol. 2014 Jan;43(1):60-4. doi: 10.1002/uog.12578.

ReferenceCitation: Jelin E, Hirose S, Rand L, Curran P, Feldstein V, Guevara-Gallardo S, Jelin A, Gonzales K, Goldstein R, Lee H. Perinatal outcome of conservative management versus fetal intervention for twin reversed arterial perfusion sequence with a small acardiac twin. Fetal Diagn Ther. 2010;27(3):138-41. doi: 10.1159/000295176. Epub 2010 Mar 9.

ReferenceCitation: Lewi L, Gratacos E, Ortibus E, Van Schoubroeck D, Carreras E, Higueras T, Perapoch J, Deprest J. Pregnancy and infant outcome of 80 consecutive cord coagulations in complicated monochorionic multiple pregnancies. Am J Obstet Gynecol. 2006 Mar;194(3):782-9.

ReferenceCitation: Kerstjens JM, Nijhuis A, Hulzebos CV, van Imhoff DE, van Wassenaer-Leemhuis AG, van Haastert IC, Lopriore E, Katgert T, Swarte RM, van Lingen RA, Mulder TL, Laarman CR, Steiner K, Dijk PH. The Ages and Stages Questionnaire and Neurodevelopmental Impairment in Two-Year-Old Preterm-Born Children. PLoS One. 2015 Jul 20;10(7):e0133087. doi: 10.1371/journal.pone.0133087. eCollection 2015.

lead_sponsor: Universitaire Ziekenhuizen KU Leuven

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
United States
France
Israel
Belgium
Germany

location_facility: Universitätsklinik für Frauenheilkunde und Geburtshilfe

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_facility: Centre Médico-Chirurgical et Obstétrical

location_facility: St. George's Hospital, University of London (UK sponsor)


title: A Prospective, Observational Long-term Follow-up Trial of Kidney Transplant Patients Treated With Imlifidase or Plasma Exchange After an Active/Chronic Active Antibody-Mediated Rejection Episode

lead_sponsor: Hansa Biopharma AB

location_country: Austria Germany France

location_facility: Hôpital Saint-Louis. Service de Néphrologie et Transplantation

location_facility: Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie MUW

location_facility: CHU Grenoble Alpes - Néphrologie, dialyse et transplantation

location_facility: Hôpital Necker - Service de Néphrologie - Transplantation

summary: The aim of this trial is to collect data and provide a better understanding of the long-term outcome of imlifidase treatment on active or chronic active antibody-mediated rejection (AMR) in kidney transplant recipients. This is done by collecting data during an extended follow-up period of 3 years of clinical study trial 16-HMedIdeS-12, in which patients received either imlifidase or plasma exchange (PE) as AMR treatment. Data for parameters such as kidney graft survival, patient survival, kidney function, treatment of rebound of donor specific antibodies (DSA) and anti-drug antibodies (ADAs) are collected.


title: BIOMARGIN European, Ambispective Cohort of Adult and Paediatric Renal Transplant Patients for the Evaluation of the Diagnostic and Prognostic Performance of Biomarkers of Renal Graft Injuries

acronym: BECS

summary:
Biomargin is a European research program aimed at evaluating the diagnostic performance of biomarkers with respect to renal graft injuries, as well as their prognostic performance with respect to 3-year and 5-year graft outcomes.

Nucleic acids, proteins and metabolites previously identified as candidate biomarkers of individual kidney graft lesions will be determined systematically in urine and blood samples collected in patients from the time of transplantation onwards, as well as in the graft tissue when biopsies are required for medical causes or performed systematically in the investigation centres. Their diagnostic and prognostic performance will be checked against histological reading of the biopsies and evolution of the graft function over time.

ReferenceCitation: Van Loon E, Gazut S, Yazdani S, Lerut E, de Loor H, Coemans M, Noël LH, Thorrez L, Van Lommel L, Schuit F, Sprangers B, Kuypers D, Essig M, Gwinner W, Anglicheau D, Marquet P, Naesens M. Development and validation of a peripheral blood mRNA assay for the assessment of antibody-mediated kidney allograft rejection: A multicentre, prospective study. EBioMedicine. 2019 Aug;46:463-472. doi: 10.1016/j.ebiom.2019.07.028. Epub 2019 Aug 1.

lead_sponsor: University Hospital, Limoges

location_country: Germany France Belgium

location_facility:
University Hospital - INSERM
University of Leuven - KU Leuven
Medizinische Hochschule Hannover (MHH)
Purpan Children University Hospital
Necker Children University Hospital


title: A New Adaptive Feeding Plan for Newborns: Effects on Gut Maturity and Gut Microbiota

summary: The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.

lead_sponsor: Nestlé

location_country: Austria France Greece

location_facility: Hôpital Charles Nicolle, Département de Pédiatrie

location_facility: Alexandra Regional General Hospital, Department of Neonatology

location_facility: Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse

location_facility: Maternité Régionale, Service de Néonatologie


title: A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants With Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer With Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST)

acronym: ZEST

summary: This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor [HR] status, including HR positive [+] and TNBC) or tumor BRCA wild type (tBRCAwt) TNBC with molecular disease based on the presence of circulating tumor Deoxyribonucleic acid (ctDNA) following surgery or completion of adjuvant therapy. Participants who have completed definitive therapy at any time in the past are eligible for ctDNA monitoring and potential enrollment onto the trial.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Norway
Brazil
Canada
Switzerland
Germany
Ireland
Finland
France
Chile
Netherlands


title: A Study to Evaluate the Safety and the Efficacy of Transient Opening of the Blood-brain Barrier (BBB) by Low Intensity Pulsed Ultrasound With the SonoCloud-9 Implantable Device in Recurrent Glioblastoma Patients Eligible for Surgery and for Carboplatin Chemotherapy

summary:
Recurrent glioblastoma (GBM) is a disease with high unmet clinical need. The standard of care for patients with GBM includes surgery, radiotherapy and chemotherapy. Despite this aggressive treatment, the overall median survival of patients with GBM remains at 15-20 months.

In more than 95% of cases, tumor recurrence is observed within 2 cm to 3 cm of the resection cavity within 4-7 months after initial treatments. One of the main causes of recurrence is the inability of chemotherapies to enter the brain from the systemic circulation due to the blood-brain barrier (BBB). The BBB is unique to cerebral blood vessels and blocks most drugs from entering the brain in sufficient concentrations.

The SonoCloud-9 (SC9) System delivers ultrasound to locally and transiently increase the permeability of the BBB to allow the passage of drugs into the cerebral parenchyma. The SC9 is dimensioned to cover the resection area and surrounding tissues in patients with recurrent GBM. The large sonicated volume covered by the SC9 device allows for broad BBB disruption and should allow for carboplatin chemotherapy to penetrate the surrounding tumor infiltrative area. By enhancing drug concentrations, it is hypothesized that further disease progression will be prevented.

ReferenceCitation: Carpentier A, Canney M, Vignot A, Reina V, Beccaria K, Horodyckid C, Karachi C, Leclercq D, Lafon C, Chapelon JY, Capelle L, Cornu P, Sanson M, Hoang-Xuan K, Delattre JY, Idbaih A. Clinical trial of blood-brain barrier disruption by pulsed ultrasound. Sci Transl Med. 2016 Jun 15;8(343):343re2. doi: 10.1126/scitranslmed.aaf6086.

lead_sponsor: CarThera

location_country:
United States
France

location_facility:
Hôpital de la Pitié-Salpêtrière
CHU
Hôpital de La Timone
Northwestern University
Hôpital Neurologique Pierre Wertheimer
MD Anderson Cancer Center


title: A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled, Multicenter, Single and Multiple Ascending Dose Study of NI006 in Patients With Amyloid Transthyretin Cardiomyopathy Followed by an Open-Label Extension

summary: A phase 1, randomized, placebo-controlled, double-blind, dose escalation trial combining single-ascending dose and multiple-ascending dose phases of NI006 or placebo, followed by an open-label extension phase in subjects with Amyloid Transthyretin Cardiomyopathy (ATTR-CM).

ipd_sharing: Undecided

lead_sponsor: Neurimmune AG

location_country: Germany France Netherlands Spain

location_facility: Hospital Universitario Puerta de Hierro Majadahonda


title: Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.

acronym: CirB-RNA

summary: The " CirB-RNA " cohort aims to create a biological collection associated with clinical and biological data from patients with hepatitis B infection. This project is part of a much larger program that aims to characterize and quantify circulating viral RNAs as a possible new biomarker of hepatitis B functional cure.

lead_sponsor: Hospices Civils de Lyon

location_country: France Italy

location_facility: Gastroenterology and Hepatology department - • Università degli Studi di Palermo

location_facility: Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant

location_facility: Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Infectious diseases and hepatology unit - Azienda Ospedaliero

location_facility: Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales

location_facility: Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse


title: A Phase I/II, Open-label, Dose-Escalating Study With a Proof of Concept Cohort to Evaluate the Safety, Tolerability and Efficacy of ARGX-110 in Combination With Azacytidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) of ARGX-110 and/or the recommended Phase II dose (RP2D) in combination with a standard dose of azacytidine (AZA) in Phase 1; and to evaluate efficacy of ARGX-110 when administered at a RP2D level established in Phase I in combination with a standard dose of AZA (proof-of concept) by evaluating overall response rate (ORR) in Phase 2.

ReferenceCitation: Riether C, Pabst T, Höpner S, Bacher U, Hinterbrandner M, Banz Y, Müller R, Manz MG, Gharib WH, Francisco D, Bruggmann R, van Rompaey L, Moshir M, Delahaye T, Gandini D, Erzeel E, Hultberg A, Fung S, de Haard H, Leupin N, Ochsenbein AF. Targeting CD70 with cusatuzumab eliminates acute myeloid leukemia stem cells in patients treated with hypomethylating agents. Nat Med. 2020 Sep;26(9):1459-1467. doi: 10.1038/s41591-020-0910-8. Epub 2020 Jun 29.

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC


title: An Open-label Study to Assess the Long-term Safety and Efficacy of ONO/GS-4059 in Subjects With Relapsed/Refractory B-cell Malignancies

summary: The primary objective of this study is to determine the long-term safety and tolerability of tirabrutinib in adults with relapsed/refractory B-cell malignancy who have tolerated and achieved stable disease or improved with tirabrutinib treatment while enrolled in a prior (parent study) tirabrutinib study (NCT01659255). The dosing regimen will be based on the prior dosing regimen from the parent study.

ReferenceCitation: Yu H, Truong H, Mitchell SA, Liclican A, Gosink JJ, Li W, Lin J, Feng JY, Jürgensmeier JM, Billin A, Xu R, Patterson S, Pagratis N. Homogeneous BTK Occupancy Assay for Pharmacodynamic Assessment of Tirabrutinib (GS-4059/ONO-4059) Target Engagement. SLAS Discov. 2018 Oct;23(9):919-929. doi: 10.1177/2472555218786165. Epub 2018 Jul 16.

ReferenceCitation: Rule SA, Cartron G, Fegan C, Morschhauser F, Han L, Mitra S, Salles G, Dyer MJS. Long-term follow-up of patients with mantle cell lymphoma (MCL) treated with the selective Bruton's tyrosine kinase inhibitor tirabrutinib (GS/ONO-4059). Leukemia. 2020 May;34(5):1458-1461. doi: 10.1038/s41375-019-0658-7. Epub 2019 Dec 11.

ReferenceCitation: Walter HS, Jayne S, Rule SA, Cartron G, Morschhauser F, Macip S, Karlin L, Jones C, Herbaux C, Quittet P, Shah N, Hutchinson CV, Fegan C, Yang Y, Mitra S, Salles G, Dyer MJS. Long-term follow-up of patients with CLL treated with the selective Bruton's tyrosine kinase inhibitor ONO/GS-4059. Blood. 2017 May 18;129(20):2808-2810. doi: 10.1182/blood-2017-02-765115. Epub 2017 Apr 4.

ReferenceCitation: Walter HS, Rule SA, Dyer MJ, Karlin L, Jones C, Cazin B, Quittet P, Shah N, Hutchinson CV, Honda H, Duffy K, Birkett J, Jamieson V, Courtenay-Luck N, Yoshizawa T, Sharpe J, Ohno T, Abe S, Nishimura A, Cartron G, Morschhauser F, Fegan C, Salles G. A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies. Blood. 2016 Jan 28;127(4):411-9. doi: 10.1182/blood-2015-08-664086. Epub 2015 Nov 5.

ReferenceCitation: Walter HS, Salles GA, Dyer MJ. New Agents to Treat Chronic Lymphocytic Leukemia. N Engl J Med. 2016 Jun 2;374(22):2185-6. doi: 10.1056/NEJMc1602674.

lead_sponsor: Gilead Sciences

location_facility:
Hopital Saint Eloi
Derriford Hospital
Leicester Royal Infirmary
University Hospital of Wales
Centre Hospitalier Lyon Sud
CHRU de Lille


title: A Phase 2, Open-label, Single-arm Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of 12 Weeks Treatment With Simeprevir and Daclatasvir in Subjects With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.

summary: The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)

lead_sponsor: Janssen R&D Ireland


title: Post Market Study to Evaluate Safety and Effectiveness of the InnFocus Microshunt™ (MIDI Arrow) in Patients With Primary Open Angle Glaucoma

summary: Prospective, multicentric, single arm post market study to gather safety and effectiveness data on the CE Marked InnFocus MicroShunt (MIDI Arrow) device in primary open angle glaucoma patients

ReferenceCitation: Beckers HJM, Aptel F, Webers CAB, Bluwol E, Martínez-de-la-Casa JM, García-Feijoó J, Lachkar Y, Méndez-Hernández CD, Riss I, Shao H, Pinchuk L, Angeles R, Sadruddin O, Shaarawy TM. Safety and Effectiveness of the PRESERFLO® MicroShunt in Primary Open-Angle Glaucoma: Results from a 2-Year Multicenter Study. Ophthalmol Glaucoma. 2022 Mar-Apr;5(2):195-209. doi: 10.1016/j.ogla.2021.07.008. Epub 2021 Jul 28.

lead_sponsor: InnFocus Inc.

location_country: Netherlands France Switzerland Spain

location_facility: Clinicovision - Hospital Clinico San Carlos

location_facility: Pole Ophtalmologique de la Clinique Mutualiste

location_facility: Clinique Ophtalmologique Universitaire de Grenoble, Hôpital A. Michallon - CHU de Grenoble

location_facility: Groupe hospitalier Paris Saint-Joseph, Service d'Ophtalmologie

location_facility: Hôpitaux Universitaires de Genève, Policlinique d'Ophtalmologie


title: An Open-label, Multi-Center, Non-Randomised Phase I Dose-Escalation Study to Investigate the Safety and Tolerability of ONO-4059 (ONO/GS-4059) Given as Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma (NHL) and Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL)

summary: The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

ReferenceCitation: Fegan, C, Bagshawe J, Salles G, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity and well tolerated in patients with high risk chronic lymphocytic leukaemia (CLL). Paper presented at: 56th American Society of Hematology Annual Meeting and Exposition; December 6-9, 2014; San Franscisco, CA.

ReferenceCitation: Morschhauser F, Terriou L, Dyer M, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity in patients with relapsed and refractory NHL. Haematologica. 2014 Jun; 99: 150.

location_facility:
Centre hospitalier Lyon Sud
CHU St Eloi
CHRU - Hopital Claude HURIEZ
Derriford Hospital
Leicester Royal Infirmary
University Hospital of Wales


title: A Randomised, Double-blind, Placebo-controlled, Multi National, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablet, Starting 2 Months Before the Grass Pollen Season Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

summary: The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.

lead_sponsor: Stallergenes Greer

location_country: France Spain Italy

location_facility:
Complejo Hospitalario de Caceres
HGU La Paz
Hop Montauban
Azienda Ospedaliera
Cab medical
Stallergenes Sa


title: Phase II Open-label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily or Twice Daily at 1250 mg as Second-line Monotherapy in Patients With Stage IIIB or Stage IV Non-small-cell Lung Cancer (NSCLC)

summary: The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.

ReferenceCitation: Gauler TC, Besse B, Mauguen A, Meric JB, Gounant V, Fischer B, Overbeck TR, Krissel H, Laurent D, Tiainen M, Commo F, Soria JC, Eberhardt WEE. Phase II trial of PTK787/ZK 222584 (vatalanib) administered orally once-daily or in two divided daily doses as second-line monotherapy in relapsed or progressing patients with stage IIIB/IV non-small-cell lung cancer (NSCLC). Ann Oncol. 2012 Mar;23(3):678-687. doi: 10.1093/annonc/mdr255. Epub 2011 May 26.

lead_sponsor: Bayer

location_country: Germany France


title: Outcome of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab (CREHA Study)

acronym: CREHA

summary: CREHA project is a study comparing steroid combined with cyclophosphamide versus steroid combined with rituximab in patients with acquired haemophilia. The study will test the hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus rituximab for FVIII inhibitor eradication in acquired haemophilia.

lead_sponsor: University Hospital, Rouen

location_facility: University Hospital of Brest - Hospital La cavale Blanche

location_facility: Regional Center of Haemophilia Treatment (CRTH) de Lorraine

location_facility: University Hospital of Bordeaux - Hospital Haut-Lévêque

location_facility: AP-HM, University Hospital La Conception

location_facility: Europen Hospital of Georges Pompidou (HEGP)

location_facility: University Regional Hospital Hautepierre

location_facility: University Hospital of Dijon - Hospital Général

location_facility: University Hospital of Nantes, Hospital Hôtel-Dieu


title: Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry

acronym: PRIME-MR

summary: This multinational, non-interventional, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR).

time_perspective: Retrospective

lead_sponsor: Universitätsklinikum Hamburg-Eppendorf

location_country:
Germany
United States
France

location_facility: University Heart & Vascular Center Hamburg

location_facility: Université Lille, Inserm, Centre Hospitalier Universitaire de Lille

location_facility: University Hospital of Rennes, Centre Hospitalier de Rennes


title: A Phase II Study to Evaluate the Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)

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

location_country:
Ireland
United States
Spain
France

location_facility:
Novartis Investigative Site
Boston Childrens Hospital

summary: This is a prospective interventional Phase II multi center study, open label, preceded by a retrospective non-interventional period, to assess the long-term safety and efficacy of alpelisib, in pediatric and adult participants with PROS.


title: Prospective, Multi-country, Observational Registry to Collect Clinical Information on Patients With Endogenous Cushing's Syndrome to Assess Drug Utilization Pattern and to Document the Safety and Effectiveness of Ketoconazole.

acronym: KetoPASS

summary: This is a non-interventional, prospective, multinational, multicentre, observational study, in which data collected are those derived from routine clinical practice via an European registry on CS: ERCUSYN.

lead_sponsor: HRA Pharma

location_country: Sweden Croatia France Spain

location_facility: Institut de Recerca de la Santa Creu i Sant Pau


title: R-One Efficiency For PCI Evolution With Robotic Assistance

acronym: R-EVOLUTION

summary: This study is a Prospective, Multi-center, Single-arm clinical study, in patients with Coronary Artery Disease, including patients with silent ischemia (excluding STEMI), who qualify for elective Percutaneous Coronary Intervention (PCI), aimed to assess the Safety and Efficacy of the R-One device in elective PCI.

lead_sponsor: Robocath

location_country: Netherlands France Luxembourg Belgium

location_facility:
Het Ziekenhuisnetwerk Antwerpen vzw
CHU Rouen
CHU Caen Normandie
INCCI
Maastad Ziekenhuis
Clinique Pasteur


intervention_type: Genetic

title: Validation Study to Investigate the Effect of a New Treatment in Patients With Osteoarthritic Pain of Knee or Hip

location_country:
France
United Kingdom
Belgium

location_facility: Hopital Saint Antoine AP-HP Rhumatologie

location_facility: Hopital Cochin AP-HP Evaluation et traitement de la Douleur

location_facility: CHU Liège, Médecine de l'appareil locomoteur

summary: The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response


title: A Phase I , Open Label, Single Center, Dose Escalation Study to Assess the Pharmacokinetics, Safety and Tolerability of a Single Dose of a New Extended Long-acting Formulation of Octreotide Pamoate Administered i.m. in Healthy Cholecystectomized Volunteers

summary: This study will assess the pharmacokinetic profile, safety and tolerability of an octreotide extended long-acting formulation after a single dose in humans. It will investigate the profile of a single dose of drug in a healthy volunteer subject in order to understand the timing and extent of fluctuations in octreotide concentrations in the blood with this formulation, the relationship of drug concentration with dose, and how long the drug remains in the body system.

location_country: France Italy Belgium


title: A Phase I Trial Evaluating a Mutanome-directed Immunotherapy in Patients With High Grade Serous Carcinoma (HGSC) of the Ovary, Fallopian Tube or Peritoneum.

summary: This is a multicenter, open-label, single arm phase I study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.

lead_sponsor: Transgene

location_facility:
Mayo Clinic Rochester
Mayo Clinic Phoenix
Mayo Clinic Jacksonville
IUCT Toulouse
Hôpital Pitié-Salpêtrière
Institut Curie