acronym: EWALL-INO

title: A Phase 2 Study of Inotuzumab Ozogamicin (INO) Combined to Chemotherapy in Older Patients With Philadelphia Chromosome-negative CD22+ B-cell Precursor Acute Lymphoblastic Leukemia

lead_sponsor: Versailles Hospital

location_facility:
CHU Besançon
CH Valenciennes
HIA Percy
CHU Strasbourg
Hopital St Antoine
CHU Angers
CH Lyon Sud
CH Roubaix
CH Reims
CHRU Nancy
Hopital Mondor
Hopital Avicenne
CHU Nice
CHR Orléans
Hopital St Louis
IUCT Oncopole
CH metropole Savois_ chambery
CHU Haut Leveque
CHU Grenoble
CH Meaux
Institut de cancerologie
Centre H Becquerel Rouen
CHU Nantes
CH Montpellier
Centre Lacassagne
CHU Caen
CH Versailles
IPC
Hopital Dijon
CHU Limoges
Hopital Duchenne
Hopital Necker
CH Amiens sud
Centre Leon Berard
CHU Clermond Ferrand

summary: The aim of the present EWALL-INO study is to confirm very promising results obtained with a combination of INO and mild chemotherapy in older de novo CD22+ B-ALL patients. For that purpose, safety and efficacy of a weekly INO administration combined to mild-intensity chemotherapy will be evaluated in a cohort of patients aged more than 55 years with newly diagnosed previously untreated Ph-negative (CD22+) BCP-ALL. Conversely to the MDACC miniHCVD-INO study and in order to lower the overall toxicity of the combination, INO will be given as part of the remission induction treatment phase during the first 2 treatment cycles only, in combination with corticosteroid, vincristine, cyclophosphamide and intrathecal prophylaxis only; then, all responding patients will received standard INO-free chemotherapy as consolidation and maintenance.


title: ANRS CO1 EPF Prospective Observational Cohort Study on Mother-to-child Transmission HIV1 and/or HIV2 and Prevention

acronym: EPF

summary: The purpose of this study is to describe over time the rate of mother to child transmission of HIV and its prevention (PMTCT), to identify risk factors for transmission and to evaluate the safety of PMTCT strategies on outcome of pregnancy and in children not infected with HIV

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Mandelbrot L, Tubiana R, Le Chenadec J, Dollfus C, Faye A, Pannier E, Matheron S, Khuong MA, Garrait V, Reliquet V, Devidas A, Berrebi A, Allisy C, Elleau C, Arvieux C, Rouzioux C, Warszawski J, Blanche S; ANRS-EPF Study Group. No perinatal HIV-1 transmission from women with effective antiretroviral therapy starting before conception. Clin Infect Dis. 2015 Dec 1;61(11):1715-25. doi: 10.1093/cid/civ578. Epub 2015 Jul 21.

ReferenceCitation: Taron-Brocard C, Le Chenadec J, Faye A, Dollfus C, Goetghebuer T, Gajdos V, Labaune JM, Perilhou A, Mandelbrot L, Blanche S, Warszawski J; France REcherche Nord&Sud Sida-HIV Hepatites - Enquete Perinatale Francaise - CO1/CO11 Study Group. Increased risk of serious bacterial infections due to maternal immunosuppression in HIV-exposed uninfected infants in a European country. Clin Infect Dis. 2014 Nov 1;59(9):1332-45. doi: 10.1093/cid/ciu586. Epub 2014 Jul 22.

ReferenceCitation: Sibiude J, Mandelbrot L, Blanche S, Le Chenadec J, Boullag-Bonnet N, Faye A, Dollfus C, Tubiana R, Bonnet D, Lelong N, Khoshnood B, Warszawski J. Association between prenatal exposure to antiretroviral therapy and birth defects: an analysis of the French perinatal cohort study (ANRS CO1/CO11). PLoS Med. 2014 Apr 29;11(4):e1001635. doi: 10.1371/journal.pmed.1001635. eCollection 2014 Apr.

ReferenceCitation: Briand N, Jasseron C, Sibiude J, Azria E, Pollet J, Hammou Y, Warszawski J, Mandelbrot L. Cesarean section for HIV-infected women in the combination antiretroviral therapies era, 2000-2010. Am J Obstet Gynecol. 2013 Oct;209(4):335.e1-335.e12. doi: 10.1016/j.ajog.2013.06.021. Epub 2013 Jun 18.

ReferenceCitation: Briand N, Warszawski J, Mandelbrot L, Dollfus C, Pannier E, Cravello L, Nguyen R, Matheron I, Winer N, Tubiana R, Rouzioux C, Faye A, Blanche S; ANRS-EPF CO1-CO11 Study Group. Is intrapartum intravenous zidovudine for prevention of mother-to-child HIV-1 transmission still useful in the combination antiretroviral therapy era? Clin Infect Dis. 2013 Sep;57(6):903-14. doi: 10.1093/cid/cit374. Epub 2013 May 31.

ReferenceCitation: Rachas A, Warszawski J, Le Chenadec J, Legeai C, Teglas JP, Goujard C, Rouzioux C, Mandelbrot L, Tubiana R, Meyer L. Does pregnancy affect the early response to cART? AIDS. 2013 Jan 28;27(3):357-67. doi: 10.1097/QAD.0b013e32835ac8bc.

ReferenceCitation: Jasseron C, Mandelbrot L, Dollfus C, Trocmé N, Tubiana R, Teglas JP, Faye A, Rouzioux C, Blanche S, Warszawski J. Non-disclosure of a pregnant woman's HIV status to her partner is associated with non-optimal prevention of mother-to-child transmission. AIDS Behav. 2013 Feb;17(2):488-97. doi: 10.1007/s10461-011-0084-y.

ReferenceCitation: Simon A, Warszawski J, Kariyawasam D, Le Chenadec J, Benhammou V, Czernichow P, Foissac F, Laborde K, Tréluyer JM, Firtion G, Layouni I, Munzer M, Bavoux F, Polak M, Blanche S; ANRS French Perinatal Cohort Study Group. Association of prenatal and postnatal exposure to lopinavir-ritonavir and adrenal dysfunction among uninfected infants of HIV-infected mothers. JAMA. 2011 Jul 6;306(1):70-8. doi: 10.1001/jama.2011.915.

ReferenceCitation: Sibiude J, Warszawski J, Tubiana R, Dollfus C, Faye A, Rouzioux C, Teglas JP, Ekoukou D, Blanche S, Mandelbrot L. Premature delivery in HIV-infected women starting protease inhibitor therapy during pregnancy: role of the ritonavir boost? Clin Infect Dis. 2012 May;54(9):1348-60. doi: 10.1093/cid/cis198. Epub 2012 Mar 28.

ReferenceCitation: Tubiana R, Le Chenadec J, Rouzioux C, Mandelbrot L, Hamrene K, Dollfus C, Faye A, Delaugerre C, Blanche S, Warszawski J. Factors associated with mother-to-child transmission of HIV-1 despite a maternal viral load <500 copies/ml at delivery: a case-control study nested in the French perinatal cohort (EPF-ANRS CO1). Clin Infect Dis. 2010 Feb 15;50(4):585-96. doi: 10.1086/650005.

ReferenceCitation: Briand N, Mandelbrot L, Le Chenadec J, Tubiana R, Teglas JP, Faye A, Dollfus C, Rouzioux C, Blanche S, Warszawski J; ANRS French Perinatal Cohort. No relation between in-utero exposure to HAART and intrauterine growth retardation. AIDS. 2009 Jun 19;23(10):1235-43. doi: 10.1097/QAD.0b013e32832be0df.

ReferenceCitation: Mandelbrot L, Jasseron C, Ekoukou D, Batallan A, Bongain A, Pannier E, Blanche S, Tubiana R, Rouzioux C, Warszawski J; ANRS French Perinatal Cohort (EPF). Amniocentesis and mother-to-child human immunodeficiency virus transmission in the Agence Nationale de Recherches sur le SIDA et les Hépatites Virales French Perinatal Cohort. Am J Obstet Gynecol. 2009 Feb;200(2):160.e1-9. doi: 10.1016/j.ajog.2008.08.049. Epub 2008 Nov 4.

ReferenceCitation: Jasseron C, Mandelbrot L, Tubiana R, Teglas JP, Faye A, Dollfus C, Le Chenadec J, Rouzioux C, Blanche S, Warszawski J; ANRS French Perinatal Cohort. Prevention of mother-to-child HIV transmission: similar access for sub-Sahara African immigrants and for French women? AIDS. 2008 Jul 31;22(12):1503-11. doi: 10.1097/QAD.0b013e3283065b8c.

ReferenceCitation: Benhammou V, Warszawski J, Bellec S, Doz F, André N, Lacour B, Levine M, Bavoux F, Tubiana R, Mandelbrot L, Clavel J, Blanche S; ANRS-Enquête Périnatale Française. Incidence of cancer in children perinatally exposed to nucleoside reverse transcriptase inhibitors. AIDS. 2008 Oct 18;22(16):2165-77. doi: 10.1097/QAD.0b013e328311d18b. Erratum in: AIDS. 2012 May 15;26(8):1047. Carbillon, François F [corrected to Carbillon, L].

ReferenceCitation: Warszawski J, Tubiana R, Le Chenadec J, Blanche S, Teglas JP, Dollfus C, Faye A, Burgard M, Rouzioux C, Mandelbrot L; ANRS French Perinatal Cohort. Mother-to-child HIV transmission despite antiretroviral therapy in the ANRS French Perinatal Cohort. AIDS. 2008 Jan 11;22(2):289-99.

ipd_sharing: No

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_facility: Centre Hospitalier Général- Hôpital Delafontaine

location_facility: Groupe Hospitalier Cochin Tarnier Port-Royal

lead_sponsor_type: academique

status_simplified: Ongoing


title: ANRS CO10 EPF - Cohort of HIV-infected Children

summary: The purpose of this study is to describe the conditions of access to early treatment of children infected with HIV, their management on the long-term, and impact on growth, clinical and immunovirological prognosis, adherence to treatment, living conditions

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceCitation: Frange P, Faye A, Avettand-Fenoël V, Bellaton E, Descamps D, Angin M, David A, Caillat-Zucman S, Peytavin G, Dollfus C, Le Chenadec J, Warszawski J, Rouzioux C, Sáez-Cirión A; ANRS EPF-CO10 Pediatric Cohort and the ANRS EP47 VISCONTI study group. HIV-1 virological remission lasting more than 12 years after interruption of early antiretroviral therapy in a perinatally infected teenager enrolled in the French ANRS EPF-CO10 paediatric cohort: a case report. Lancet HIV. 2016 Jan;3(1):e49-54. doi: 10.1016/S2352-3018(15)00232-5. Epub 2015 Dec 9.

ReferenceCitation: Aupiais C, Faye A, Le Chenadec J, Rouzioux C, Bouallag N, Laurent C, Blanche S, Dollfus C, Warszawski J; ANRS EPF-CO10 French Pediatric Cohort. Interruption of cART in clinical practice is associated with an increase in the long-term risk of subsequent immunosuppression in HIV-1-infected children. Pediatr Infect Dis J. 2014 Dec;33(12):1237-45. doi: 10.1097/INF.0000000000000450.

ReferenceCitation: Sofeu CL, Warszawski J, Ateba Ndongo F, Penda IC, Tetang Ndiang S, Guemkam G, Makwet N, Owona F, Kfutwah A, Tchendjou P, Texier G, Tchuente M, Faye A, Tejiokem MC; ANRS-PEDIACAM Study Group. Low birth weight in perinatally HIV-exposed uninfected infants: observations in urban settings in Cameroon. PLoS One. 2014 Apr 3;9(4):e93554. doi: 10.1371/journal.pone.0093554. eCollection 2014.

ReferenceCitation: Blanche S, Scott-Algara D, Le Chenadec J, Didier C, Montange T, Avettand-Fenoel V, Rouzioux C, Mélard A, Viard JP, Dollfus C, Bouallag N, Warszawski J, Buseyne F. Naive T lymphocytes and recent thymic emigrants are associated with HIV-1 disease history in french adolescents and young adults infected in the perinatal period: the ANRS-EP38-IMMIP study. Clin Infect Dis. 2014 Feb;58(4):573-87. doi: 10.1093/cid/cit729. Epub 2013 Nov 18.

ReferenceCitation: Avettand-Fenoel V, Blanche S, Le Chenadec J, Scott-Algara D, Dollfus C, Viard JP, Bouallag N, Benmebarek Y, Rivière Y, Warszawski J, Rouzioux C, Buseyne F. Relationships between HIV disease history and blood HIV-1 DNA load in perinatally infected adolescents and young adults: the ANRS-EP38-IMMIP study. J Infect Dis. 2012 May 15;205(10):1520-8. doi: 10.1093/infdis/jis233. Epub 2012 Mar 15.

ReferenceCitation: Goetghebuer T, Le Chenadec J, Haelterman E, Galli L, Dollfus C, Thorne C, Judd A, Keiser O, Ramos JT, Levy J, Warszawski J; European Infant Collaboration Group. Short- and long-term immunological and virological outcome in HIV-infected infants according to the age at antiretroviral treatment initiation. Clin Infect Dis. 2012 Mar;54(6):878-81. doi: 10.1093/cid/cir950. Epub 2011 Dec 23.

ReferenceCitation: Judd A; European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) study group in EuroCoord. Early antiretroviral therapy in HIV-1-infected infants, 1996-2008: treatment response and duration of first-line regimens. AIDS. 2011 Nov 28;25(18):2279-87. doi: 10.1097/QAD.0b013e32834d614c.

ReferenceCitation: Pursuing Later Treatment Options II (PLATO II) project team for the Collaboration of Observational HIV Epidemiological Research Europe (COHERE), Castro H, Judd A, Gibb DM, Butler K, Lodwick RK, van Sighem A, Ramos JT, Warsawski J, Thorne C, Noguera-Julian A, Obel N, Costagliola D, Tookey PA, Colin C, Kjaer J, Grarup J, Chene G, Phillips A. Risk of triple-class virological failure in children with HIV: a retrospective cohort study. Lancet. 2011 May 7;377(9777):1580-7. doi: 10.1016/S0140-6736(11)60208-0. Epub 2011 Apr 20.

ReferenceCitation: Dollfus C, Le Chenadec J, Faye A, Blanche S, Briand N, Rouzioux C, Warszawski J. Long-term outcomes in adolescents perinatally infected with HIV-1 and followed up since birth in the French perinatal cohort (EPF/ANRS CO10). Clin Infect Dis. 2010 Jul 15;51(2):214-24. doi: 10.1086/653674.

ReferenceCitation: Goetghebuer T, Haelterman E, Le Chenadec J, Dollfus C, Gibb D, Judd A, Green H, Galli L, Ramos JT, Giaquinto C, Warszawski J, Levy J; European Infant Collaboration group. Effect of early antiretroviral therapy on the risk of AIDS/death in HIV-infected infants. AIDS. 2009 Mar 13;23(5):597-604. doi: 10.1097/QAD.0b013e328326ca37.

ReferenceCitation: Collaboration of Observational HIV Epidemiological Research Europe (COHERE) Study Group, Sabin CA, Smith CJ, d'Arminio Monforte A, Battegay M, Gabiano C, Galli L, Geelen S, Gibb D, Guiguet M, Judd A, Leport C, Dabis F, Pantazis N, Porter K, Raffi F, Thorne C, Torti C, Walker S, Warszawski J, Wintergerst U, Chene G, Lundgren J. Response to combination antiretroviral therapy: variation by age. AIDS. 2008 Jul 31;22(12):1463-73. doi: 10.1097/QAD.0b013e3282f88d02.

ReferenceCitation: Warszawski J, Lechenadec J, Faye A, Dollfus C, Firtion G, Meyer L, Douard D, Monpoux F, Tricoire J, Benmebarek Y, Rouzioux C, Blanche S. Long-term nonprogression of HIV infection in children: evaluation of the ANRS prospective French Pediatric Cohort. Clin Infect Dis. 2007 Sep 15;45(6):785-94. Epub 2007 Aug 14.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Institut d'Hématologie et Oncologie Pédiatrique

status_simplified: Completed


status: Active, not recruiting

primary_purpose: Treatment

acronym: TopNIVO

intervention_type: Drug

title: A Safety Study of Nivolumab in Patients With Recurrent and/or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)

lead_sponsor: UNICANCER

type: EudraCT Number

source: euctr

study_start_date_type: Actual

study_type: Interventional

location_facility:
ICM Val d'Aurelle
Institut Jean Godinot
Centre Paul Strauss
Centre Jean Perrin
Centre Antoine Lacassagne
Institut de Cancérologie de l'Ouest
Centre Francois Baclesse
CHU Bordeaux
Centre Eugène Marquis
Centre Léon Bérard
Centre Oscar Lambret
Institut de Cancérologie de Lorraine
Hopital Tenon
Institut Claudius Regaud
Institut Curie Saint Cloud
Institut Curie
Centre Georges Francois Leclerc
Gustave Roussy

summary:
Recurrent and/or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) are a common clinical situation and although this group of patients has very heterogeneous disease characteristics, they share a dismal prognosis with a median survival time around 6-11 months and a relatively poor quality of life.

Immunotherapy approaches have recently demonstrated clinical efficacy in more than twenty cancer types, including melanoma, renal cell carcinoma, non-small cell lung cancer (NSCLC) and SCCHN. Nivolumab demonstrated significant overall survival benefit as treatment for recurrent SCCHN in a randomized phase III Study CA209141 conducted on a cohort of 361 patients (240 in the nivolumab arm and 121 in the standard therapy arm), presenting this condition and whose disease had progressed within 6 months after platinum-based chemotherapy. In this study, treatment with nivolumab resulted in significantly longer survival than treatment with standard therapy with a median overall survival of 7.5 months vs 5.1 months (p=0.01).

The main objective of the study is to provide additional insight into the frequency of high-grade AEs related to nivolumab and their outcome, and thus supplement the growing safety database of nivolumab-treated recurrent and/or metastatic squamous cell carcinoma of the head and neck patients.

lead_sponsor_type: industriel


title: A Randomized Trial Testing Early vs Late Onset of EPO Alfa Treatment in Lower Risk MDS With Non RBC Transfusion Dependent Anemia and Without Del 5q

acronym: EPO-PRETAR

summary:
This is an open-label, randomized, multicenter, phase III study

Patients with baseline Hb comprised between 9 and 10.5g/dl will be randomized to receive EPO Alfa 60000 UI/week for at least 12 weeks:

Either at diagnosis Or
at the Hb threshold chosen for RBC transfusions (must be < 9g/dl)

design_allocation: Non-Randomized

ipd_sharing: Undecided

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Centre Hospitalier Universitaire de STRASBOURG


acronym: PACMAN

title: Effects of Perioperative Administration of Dexamethasone on Postoperative Complications and Mortality After Non-cardiac Major Surgery : a Randomized, Multicentre, Double Blind, Study

lead_sponsor: Nantes University Hospital

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Asehnoune K, Le Moal C, Lebuffe G, Le Penndu M, Josse NC, Boisson M, Lescot T, Faucher M, Jaber S, Godet T, Leone M, Motamed C, David JS, Cinotti R, El Amine Y, Liutkus D, Garot M, Marc A, Le Corre A, Thomasseau A, Jobert A, Flet L, Feuillet F, Pere M, Futier E, Roquilly A; PACMAN study group. Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial. BMJ. 2021 Jun 2;373:n1162. doi: 10.1136/bmj.n1162.

ReferenceCitation: Asehnoune K, Futier E, Feuillet F, Roquilly A; PACMAN group. PACMAN trial protocol, Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac major surgery: a randomised, multicentre, double-blind, superiority study. BMJ Open. 2019 Mar 23;9(3):e021262. doi: 10.1136/bmjopen-2017-021262.

location_facility: Hôpital Estaing, CHU de Clermont Ferrand

location_facility: Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand Widal

summary:
Postoperative complications are major healthcare problems and are associated with a reduced short-term and long-term survival after surgery. Major surgery is associated with a predictable and usually transient Systemic Inflammatory Response (SIRS), depending on the magnitude of the surgical trauma. An excessive SIRS syndrome participates to the development of postoperative organ dysfunction, infection and mortality. Corticosteroids may decrease the postsurgical SIRS in cardiac surgery: in a large multicenter randomized trial, a single intravenous administration of high-dose dexamethasone did not reduce the incidence of a composite endpoint of adverse events but was associated with a reduced incidence of postoperative pulmonary complications and infections and with a reduction in hospital stay. However, a similar study, recently published in the Lancet was negative. Evidences from one meta-analysis, including 11 studies of moderate quality (439 patients in total), suggest that intraoperative administration of corticosteroids during major abdominal surgery decreases postoperative complications, including infectious complications, without significant risk of anastomotic leakage. At present, no large randomized controlled trial has been performed in patients undergoing major non-cardiac surgery. In acute medicine, several lines of evidence have shown that low to moderate doses of corticosteroids decrease the excessive inflammatory response, without inducing immuno suppression. However, despite the widespread use of corticosteroids to reduce postoperative nausea and vomiting and to improve analgesia, concerns continue to be raised about their safety, especially regarding an increased risk of postoperative infection.

We hypothesize that the perioperative administration of glucocorticoids would reduce postoperative morbidity after major non-cardiac surgery through dampening of the inflammatory response. Given the number of surgical patients for whom the question applies, the study is of significant clinical importance


title: MGMT-NET: O6-methylguanine-DNA Methyltransferase (MGMT) Status in Neuroendocrine Tumors: Predictive Factor of Response to Alkylating Agents

acronym: MGMT-NET

summary:
Neuroendocrine tumors (NET) are rare but their incidence is growing. Alkylating agents (ALKY) are one of the main systemic treatments used, at least for advanced duodeno-pancreatic NETs, with a response rate of 30 to 40% and a median progression-free survival of 4 to 18 months. Chemotherapy is one of the few therapeutic weapons, along with everolimus, somatostatin analogs, and metabolic radiotherapy, for lung NETs, called typical and atypical carcinoids, even if the level of proof of efficacy for these treatments is lower than for duodeno-pancreatic NETs. Considering the available retrospective data, O6-Methylguanine-DNA methyltransferase (MGMT) appears to be a predictive factor of the response to ALKY. Oxaliplatin (OX) has demonstrated an interesting activity, with response rates between 17% and 30%. In a first retrospective study we showed that Gemox is effective in NET, and more recently that its activity is similar to that of ALKYs, but without being influenced by the MGMT status. Prospective studies are needed but our data suggests that ALKY should be offered first to patients with methylated MGMT tumors while Oxaliplatin-based chemotherapy should be offered first to patients with unmethylated MGMT tumors.

In this project, we wish to evaluate the contribution of the MGMT methylation, evaluated in the tumor, in predicting the Objective Response (OR) in patients treated with ALKY and to evaluate a treatment with alkylating agents versus Oxaliplatin in patients with a duodeno-pancreatic or lung or unknown primitive NET.

ReferenceCitation: Lemelin A, Barritault M, Hervieu V, Payen L, Péron J, Couvelard A, Cros J, Scoazec JY, Bin S, Villeneuve L, Lombard-Bohas C, Walter T; MGMT-NET investigators. O6-methylguanine-DNA methyltransferase (MGMT) status in neuroendocrine tumors: a randomized phase II study (MGMT-NET). Dig Liver Dis. 2019 Apr;51(4):595-599. doi: 10.1016/j.dld.2019.02.001. Epub 2019 Feb 14.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Estaing, CHU de Clermont-Ferrand

location_facility: Hôpital Edouard Herriot - Hospices Civils de Lyon

location_facility: Hôpital François Mitterrand - CHU Dijon Bourgogne


title: French National Database of Rare Dermatological Cancers: Merkel Cell Carcinoma, Inoperable or Metastatic Basal Cell Carcinoma, Cutaneous Adnexal Carcinomas

acronym: CARADERM

summary:
Merkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, and cutaneous adnexal carcinomas are 3 types of rare skin cancers for which much remains unknown in terms of natural behavior, prognosis, treatment and outcomes.

CARADERM is a French prospective national cohort enrolling patients with either one of these 3 tumor types, whose objectives are :

to provide epidemiological, clinical and socio-economic characteristics of patients
to identify new clinical or epidemiological prognostic factors for these rare cancers
to evaluate the impact of various treatments on outcomes

lead_sponsor: University Hospital, Lille

location_facility:
CHU Besançon
CHU de Pointe à Pitre
CHU de Rouen
CHU de Clermont Ferrand
CHU Angers
CHU Nantes - Place Alexis Ricordeau
CHU de Caen
CHU Amiens Picardie
CHU St Louis
CHU Bichat
CHU Cochin
CHU de Strasbourg
Centre Léon Bérard
CHU Ambroise Paré
Institut Gustave Roussy
CHU de Rennes
CH Annecy Gennevois
Hôpital La Timone
CHU de Nice
CHU de Toulouse - Larrey
CHU Avicenne
Hôpital St Eloi
CHU de Bordeaux
CHU de Reims
CHU Bocage
Centre hospitalier Lyon Sud
CHU de Grenoble
CH Le Mans
CHU de Poitiers
CHU de Tours
CHU de Brest
CHR d'Orleans
CHU de Limoges
CHU de Nancy


title: A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion

acronym: THEIA

summary: The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours improve visual deficit due to acute CRAO with a good safety profile.

location_facility:
CH métropole Savoie
CH d'Arras
CHU de Strasbourg
CHU
CHU de Toulouse
CHU de Montpellier
CHU de Rennes
CHU de Nice
CHU Rouen
CH Vannes
CH Annecy Genevois
Ch Perpignan
CHD Vendée
CHRU de Besançon
CHU de Bordeaux
Vienne Hospital
CH de Saint Nazaire
CH de La Rochelle
CHU Caen
CHU de Nantes
CHU d'Angers
CHU de Poitiers
CHU de Tours
Fondation Ophtalmologique Rothschild


title: QD Isentress as Switch Strategy in Virologically Suppressed HIV-1 Infected-Patient

acronym: QDISS

summary:
Raltegravir (RAL) is a very effective antiretroviral drug with a favorable long term tolerability. RAL offers many advantages such as lack of drug-drug interactions, a good safety profile particularly on lipids, inflammation and bone parameters. Ral can be an very interesting for patient with comorbidities and comedications, intolerance or toxicities with their current ARV treatment. However its current formulation of one tablet of 400mg twice a day coul not suit many patients.

A new once-a-day formulation of RAL has been developed, with two tablets of 600 mg QD. Pharmacokinetic study in healthy volunteers has shown that this dosing provides increased RAL exposure compared to the standard formulation of 400 mg given twice a day.

The objective of this study is to evaluate the maintain of virologic suppression with raltegravir 600mg 2 tablets qd as part of a triple antiretroviral regimen in virologically controlled patients.

ReferenceCitation: Hall N, Allavena C, Katlama C, Jobert A, Molina JM, Cua E, Bani-Sadr F, Hocqueloux L, Duvivier C, Merrien D, Hikombo H, André-Garnier E, Gaultier A, Raffi F; QDISS Study Group. Raltegravir 1200 mg once daily as maintenance therapy in virologically suppressed HIV-1 infected adults: QDISS open-label trial. AIDS Res Ther. 2022 Jan 15;19(1):4. doi: 10.1186/s12981-022-00428-5.

location_facility:
CHu hotel dieu
CHU De Bordeaux
CH du Mans
CHU la pitié
CHU de Nice
Hopital St Louis
CHU de Lyon
CH de la Roche Sur Yon
Hopital Avicenne
CHRU de Tours
CHRU de Montpellier
Hopital Necker
CHU de Reims
CH de Tourcoing
CHR orléans
CHU of NANTES
CHU de Bichat


title: Multicenter Randomized Phase II Study Comparing the Effectiveness and Tolerance of Avelumab Versus Standard 2nd Line Treatment Chemotherapy in Patients With Colorectal Metastatic Cancer With Microsatellite Instability (MSI)

acronym: SAMCO

summary:
Immune chekpoints (ICI) are evaluated in many digestive cancers. Certain types of cancer appear to be rather refractory to ICI such as colorectal cancers (CRC). However, the MSI CRC representing approximately 15% of the CRCs exhibits a high mutational load which generates many potentially immunogenic neoantigens. In addition, strong expression of PD-L1 was found in the MSI CRCs relative to the CRC (MSS) stages. Localized MSI CRCs have a better prognosis than MSS CRCs, probably due to immunogenic neoantigens associated with a CD8 + T-specific immune response. On the oher hand, in metastatic CRC (mCRC) things are different because i) the MSI frequency is only 4 to 7% and ii) the good prognosis conferred by the MSI status is controversial.

Preliminary results suggest that patients with MSI mCRC are highly sensitive to ICI even chemoresistant tumors receiving several lines of chemotherapy. Recently, another anti-PD1 alone or in combination with an anti-CTLA4 (antigen associated with cytotoxic T-lymphocyte 4) was tested in the MSI CRCs and a selection of interesting results in heavily pretreated patients with a disease control rate of 56% for monotherapy and 81% for combinated therapy.

Anti-PD1s now have marketing authorization for patients with melanoma and metastatic pulmonary carcinoma , Which are known to have a high level of mutations . ICIs appear to be as promising in MSI CRCs as in other tumors and therefore face the same major challenges.

Avalumab is an anti-PD-L1 antibody recently tested in several different types of tumors with promising results and is currently being studied in phase III in gastric cancer. There is no data on the effectiveness of this ICI in the MSI mCRCs. In addition, only anti-PD1 was used in the MSI-mCRC and not the anti-PD-L1, and only in chemoresistance (3rd line or more). The main objective of the SAMCO study is to test the efficacy and tolerance of avelumab in the 2nd line of treatment in patients with a MSI mCRC progression after standard 1st line chemotherapy +/- targeted therapy.

ReferenceType: background

ReferenceCitation: Taïeb J, André T, El Hajbi F, Barbier E, Toullec C, Kim S, Bouche O, Di Fiore F, Chauvenet M, Perrier H, Evesque L, Laurent-Puig P, Emile JF, Bez J, Lepage C, Tougeron D. Avelumab versus standard second line treatment chemotherapy in metastatic colorectal cancer patients with microsatellite instability: The SAMCO-PRODIGE 54 randomised phase II trial. Dig Liver Dis. 2021 Mar;53(3):318-323. doi: 10.1016/j.dld.2020.11.031. Epub 2020 Dec 25.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Privé - Centre de Radiotherapie Et D'Oncologie Médicale de L'Essone

location_facility: Ch - Ghi de L'Est Francilien Site de Meaux

location_facility: Privé - Centre de Radiotherapie Pierre Curie

location_facility: Ch - Centre Hospitalier de Charleville Mezieres

location_facility: Ch - Centre Hospitalier de Montceau Les Mines

location_facility: Ch - Centre Hospitalier Docteur Schaffner

location_facility: Privé - Institut de Cancerologie de Bourgogne Grrecc

location_facility: Ch - Groupe Hospitalier Intercommunal Le Raincy

location_facility: Chi - Centre Hospitalier de Castres Mazamet

location_facility: Chu - Centre Hospitalier Universitaire Pontchaillou

location_facility: Privé - Centre de Cancérologie Du Grand Montpellier

location_facility: Privé - Institut de Cancerologie de Lorraine

location_facility: Privé - Clinique Mutualiste de L'Estuaire - Cite Sanitaire

location_facility: Ch - Hopital Louis Pasteur - Oncologie Hematologie

location_facility: Privé - Cac - Institut de Cancérologie de Strasbourg Europe

location_facility: Privé - Cac- Centre Georges-Francois Leclerc

location_facility: Ch - Centre Hospitalier Metropole Savoie

location_facility: Ch - Centre Hospitalier Ardeche Meridionale

location_facility: Ch - Chic - Centre Hospitalier de Cornouaille

location_facility: Chr - Centre Hospitalier Régional de La Source

location_facility: Ch - Centre Hospitalier Marne La Vallee-Jossigny


title: Prévention Des Fausses Couches Spontanées Répétées Par Hydroxychloroquine. Essai thérapeutique Multicentrique, randomisé, en Double Insu, Contre Placebo

acronym: BBQ

summary:
Recurrent miscarriage (RM) defined by >=3 consecutive losses affects 1% of fertile couples. Most women have recurrent early loss with a failure of development before 10 weeks' gestation. Standard investigations fail to reveal any apparent cause in >50% of couples.

No study has demonstrated any benefit of any medication in women with Unexplained RM, in the presence or absence of an inherited thrombophilia.

Moreover, the benefit of aspirin and/or heparin has not been proved in women with Antiphospholipid (APL) antibody without other clinical manifestations of Antiphospholipid Syndrome.

Hydroxychloroquine (HQ) is a molecule whose properties (anti-thrombotic, vascular-protective, immunomodulatory, improved glucose tolerance, lipid-lowering, anti-infectious) could be useful against mechanisms of Unexplained RM.

There is no data concerning the benefit of HQ in RM in the presence or absence of antiphospholipid antibodies or any inherited thrombophilia.

Administration in (Systemic Lupus erythematosus (SLE) women and for Malaria prevention provides extensive safety data during pregnancy.

Oral administration makes possible treatment since the preconception period. For all of that and its low cost, hydroxychloroquine should be evaluated in RM whatever the woman thrombophilic status.

ReferenceCitation: Pasquier E, de Saint-Martin L, Marhic G, Chauleur C, Bohec C, Bretelle F, Lejeune-Saada V, Hannigsberg J, Plu-Bureau G, Cogulet V, Merviel P, Mottier D. Hydroxychloroquine for prevention of recurrent miscarriage: study protocol for a multicentre randomised placebo-controlled trial BBQ study. BMJ Open. 2019 Mar 20;9(3):e025649. doi: 10.1136/bmjopen-2018-025649.

lead_sponsor: University Hospital, Brest

location_facility:
CHU Besançon
CH de Bigorre
CH de Mont de Marsan
CHU de Nantes
Centre hospitalier de Cornouaille
Hopital Saint Antoine
CHRU de Brest
Nouvel Hôpital Civil
Hôpital sud de Rennes
Centre Hospitalier Annecy Genevois
CHG François Mitterand
Hopital Port Royal Cochin
CHU de Saint Etienne - Hôpital Nord
CHU Estaing
CHRU de Lille
Hôpital Nord - Unité mère-enfant
Hôpital Bichat
CH d'Auch


title: Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation

acronym: TRAP

summary: The aim of this study is to improve the definition of the two main types of secondary tricuspid regurgitation.

status: Unknown status

lead_sponsor: Rennes University Hospital

location_facility: CHU de DIJON - HOPITAL FRANCOIS MITTERAND

location_facility: Chu de Bordeaux - Groupe Hospitalier Sud

intervention_type: Other

status_simplified: Unknown


title: Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa: An Implementation Research

summary:
Cardiovascular disease is the leading cause of death in the world. 17.5 million people died in 2012 due to a cerebrovascular disease (31% of all causes of death). In Europe more than 50% of deaths are due to cardiovascular disease. The mortality rate for cardiovascular disease is higher in the lower socio-economic levels. Three-quarters of deaths from cardiovascular disease occur in developing countries. According to estimates in 2030, cardiovascular disease will be responsible for more deaths than the sum of infectious, nutritional, maternal and perinatal diseases in developing countries.

Measures to prevent cardiovascular risk factors have been shown to be effective.

The lack of an adequate primary care network in developing countries limits the screening and treatment of patients with cardiovascular risk factors. As a result, these patients do not benefit from adequate prevention, are diagnosed late and remain disabled or die at a young age, resulting in significant additional costs for families but also at the macroeconomic level.

Interventions are possible on a large scale (policies against tobacco and adverse dietary behavior, promote physical activity, etc.). Actions are possible on an individual level, both in primary prevention (control of cardiovascular risk factors) and secondary prevention, where many treatments have proved their effectiveness. These interventions are effective and cost-effective from a macroeconomic perspective. It was estimated that the cost of such interventions would not exceed 4% of health expenditure in developing countries and 1-2% in rich countries.

The World Health Organization insists on the importance of the triad composed by the patient and his family, community and health professionals. Results are possible only when these three components work together for the same purpose. Numerous studies show the benefit of the involvement of patients in their care in the rich countries and in the developing countries.

primary_purpose: Prevention

location_facility:
Coray
Plounevez-Quintin
Nevez
Guiscriff
Plouray
LAZ
Le Faouet
Laniscat
Plonévez du Faou
La Chapelle Thouarault
Poullaouen
Roudouallec
Landeleau
Carhaix Plouguer
Chateauneuf du Faou
Spezet
Guémené-sur-Scorff
Rostrenen
Plonevez du faou
Tregourez
Saint Nicolas du Pelem


title: Double-blinded Multicenter Randomized Controlled Trial Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

acronym: AMIKINHAL

summary:
The objective of the study is to prove that after the third day of invasive mechanical ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP.

Parallel two group double blind randomized controlled clinical trial. Individual randomization, performed on day 4 of invasive mechanical ventilation, will be stratified on centre in order to account for variations in VAP prevention bundle implementation and use of systemic antibiotics the day of randomization. Patients will be treated three consecutive days with inhaled amikacin or placebo. Patients will be followed up daily in the intensive care unit for the occurrence of VAP according to international guidelines until day 28.

ReferenceCitation: Tavernier E, Barbier F, Meziani F, Quenot JP, Herbrecht JE, Landais M, Roux D, Seguin P, Schnell D, Veinstein A, Veber B, Lasocki S, Lu Q, Beduneau G, Ferrandiere M, Dahyot-Fizelier C, Plantefeve G, Nay MA, Merdji H, Andreu P, Vecellio L, Muller G, Cabrera M, Le Pennec D, Respaud R, Lanotte P, Gregoire N, Leclerc M, Helms J, Boulain T, Lacherade JC, Ehrmann S; REVA network and the CRICS-TRIGGESEP F-CRIN network. Inhaled amikacin versus placebo to prevent ventilator-associated pneumonia: the AMIKINHAL double-blind multicentre randomised controlled trial protocol. BMJ Open. 2021 Sep 14;11(9):e048591. doi: 10.1136/bmjopen-2020-048591.

lead_sponsor: University Hospital, Tours

location_facility: Service de Réanimation Médicale - Hôpital Louis Mourier

location_facility: Service de Réanimation Médicale - CHU La Milétrie

location_facility: Service de Réanimation Médicale - CHU Rouen

location_facility: Service de Réanimation Médicale - Hôpital de Hautepierre

location_facility: Service de Réanimation Médicale - Hôpital Pitié Salpêtrière

location_facility: Service de Réanimation médicale, Hôpital Trousseau

location_facility: Service de Réanimation Médicale - CHD Les Oudairies

location_facility: Service de Réanimation Médicale - CH d'Angoulême

location_facility: Service de Réanimation Médicale - Hôpital La Croix-Rousse

location_facility: Service de Réanimation Médicale - Hôpital Charles Nicolle

location_facility: Service de Réanimation Médicale - CHU Pontchaillou


title: Motivations and Psychological Aspects of the Gametes' Donation

acronym: DonDon

summary: The main objective is to study donors' personality and motivations characteristics of the different recruitment methods and thus to answer questions related to the donation's approach, its representations as well as motivations and the profile of the donors.

ReferenceCitation: Ahuja KK, Mostyn BJ, Simons EG. Egg sharing and egg donation: attitudes of British egg donors and recipients. Hum Reprod. 1997 Dec;12(12):2845-52.

ReferenceCitation: Cauvin P. [Motivations of oocytes donors]. Gynecol Obstet Fertil. 2009 Nov-Dec;37(11-12):934-41. doi: 10.1016/j.gyobfe.2009.09.003. Epub 2009 Oct 12. French.

ReferenceCitation: Pennings G. Mirror gametes donation. J Psychosom Obstet Gynaecol. 2007 Dec;28(4):187-91. Review.

ReferenceCitation: Sydsjö G, Lampic C, Brändström S, Gudmundsson J, Karlström PO, Solensten NG, Thurin-Kjellberg A, Svanberg AS. Personality characteristics in a Swedish national sample of identifiable oocyte donors. BJOG. 2011 Aug;118(9):1067-72. doi: 10.1111/j.1471-0528.2011.02953.x. Epub 2011 Apr 11.

ReferenceCitation: Sydsjö G, Lampic C, Brändström S, Gudmundsson J, Karlström PO, Solensten NG, Thurin-Kjellberg A, Skoog Svanberg A. Who becomes a sperm donor: personality characteristics in a national sample of identifiable donors. BJOG. 2012 Jan;119(1):33-9. doi: 10.1111/j.1471-0528.2011.03172.x. Epub 2011 Oct 18.

lead_sponsor: University Hospital, Toulouse

location_facility: CECOS Provence-Alpes-Côte d'Azur Marseille


title: Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis: A Randomized Controlled Study

acronym: BIGG

summary: To compare effect of intra-nodal injection of gentamicin versus placebo on the outcome at 28 days of suppurated cat scratch disease's (CSD) lymphadenitis treated by oral azithromycin.

location_facility:
Auch Hospital
Pau Hospital
Saint-Nazaire Hospital
Rodez Hospital
Saint-Brieuc Hospital
Rennes Hospital
Hospices Civils Lyon
Tarbes Hospital
Microbiology Laboratory
Nîmes University Hospital
Bordeaux University Hospital
Albi Hospital
Angers Hospital
Vendée Hospital
Montauban Hospital
Amiens-Picardie Hospital
Montpellier University Hospital
Perpignan Hospital
Cahors Hospital
Limoges University Hospital
Castres Hospital


title: Safety And Effectiveness Evaluation Of COBRA PzF™ Coronary Stent System: A French Observational Postmarketing Registry

acronym: eCOBRA

summary: A multi-center, prospective, consecutive enrolled, observational registry. The population being studied includes all patients undergoing treatment of "de novo" lesions in native coronary vessels, saphenous vein graft and/or arterial bypass conduits with the COBRA PzF coronary stent system. The registry will primarily assess the rate of MACE (cardiac death, myocardial infarction and clinically driven target lesion revascularization.

lead_sponsor: CeloNova BioSciences, Inc.

location_facility:
SCM Angioscan
Clinique La Fourcade
Centre Hospitalier
Clinique du Millenaire
Clinique St Hilaire
Infirmerie Protestante
Clinique La Casamance
Clinique des Domes
Clinique du Pont de Chaume
Polyclinique de Courlancy
Clinique Axium
Clinique St-Martin
Clinique Mutualiste
GCS Cardio
Clinique Cardiologie

intervention_type: Device


title: Collection of Additional Data Followed the Study "A Phase III Study of Velcade (Bortezomib) Thalidomide Dexaméthasone (VTD) Versus Velcade (Bortezomib) Cyclophosphamide Dexaméthasone (VCD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma"

summary: Collection of retrospective additional data (survival, biological, disease response data) following the study IFM 2013-04.

time_perspective: Retrospective

location_facility: Centre Hospitalier intercommunale Meulan les mureaux

location_facility: Centre Hospitalier de la région d'Annecy


title: Randomized, Open Label, Multicentric Phase III Trial to Evaluate the Safety and Efficacy of Palbociclib in Combination With HT Driven by ctDNA ESR1 Mutation Monitoring in ER+, HER2-negative Metastatic Breast Cancer Patients

ReferenceCitation: Bidard FC, Hardy-Bessard AC, Dalenc F, Bachelot T, Pierga JY, de la Motte Rouge T, Sabatier R, Dubot C, Frenel JS, Ferrero JM, Ladoire S, Levy C, Mouret-Reynier MA, Lortholary A, Grenier J, Chakiba C, Stefani L, Plaza JE, Clatot F, Teixeira L, D'Hondt V, Vegas H, Derbel O, Garnier-Tixidre C, Canon JL, Pistilli B, Andre F, Arnould L, Pradines A, Bieche I, Callens C, Lemonnier J, Berger F, Delaloge S; PADA-1 investigators. Switch to fulvestrant and palbociclib versus no switch in advanced breast cancer with rising ESR1 mutation during aromatase inhibitor and palbociclib therapy (PADA-1): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2022 Nov;23(11):1367-1377. doi: 10.1016/S1470-2045(22)00555-1. Epub 2022 Sep 29.

ReferenceCitation: Berger F, Marce M, Delaloge S, Hardy-Bessard AC, Bachelot T, Bièche I, Pradines A, De La Motte Rouge T, Canon JL, André F, Arnould L, Clatot F, Lemonnier J, Marques S, Bidard FC; PADA-1 investigators. Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patients: study design of PADA-1. BMJ Open. 2022 Mar 3;12(3):e055821. doi: 10.1136/bmjopen-2021-055821.

location_facility: Centre d'Oncologie radiothérapie de Macon

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau

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

location_facility: Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble

location_facility: Centre Hospitalier Départemental de Vendée

location_facility: Centre de radiothérapie et d'oncologie médicale LE-CROME

location_facility: Centre ONCOGARD - Institut de Cancérologie du Gard

location_facility: Centre Hospitalier de Tours - Hopital Bretonneau

location_facility: CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologi

summary: This study is a randomized, open-label, multicentric, phase III trial conducted in patients receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor (ER)-positive HER2-negative metastatic breast cancer and which aims to evaluate, at the onset of ESR1 mutations in circulating tumor DNA, the efficacy of a change of the hormone therapy (aromatase inhibitor (AI) changed to fulvestrant) combined to palbociclib, together with the safety of hormone therapy and palbociclib combination in the overall population.


title: A Multicenter, Double-blind, Placebo-controlled Randomized Clinical Trial Comparing Two Strategies of Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Severe Cirrhotic Patients With Ascites : Using or Not Using Rifaximin

acronym: ProPILARifax

summary: We wish to perform a multicenter, double-blind RCT with two parallel-group stratified on the center, comparing rifaximin to no rifaximin (placebo) for the primary prophylaxis of SBP in 'severe' cirrhotic patients with large ascites. The primary outcome will be the 12-month survival.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU Tours
CHU de Nice
CHU Caen
Hôpital Pitié Salpêtrière
CHU Montpellier
CHU Rouen
CHU d'Angers
Hopital de la croix-rousse
Hôpital Beaujon
Hôpital Jean Verdier
CHIC de Créteil
CHU Grenoble
CHU de Toulouse
CHU de Reims
CHRU de Lille
CHU Amiens
CHU de Besançon
CHU de Rennes


title: A Randomized Non-comparative Phase II Study of Anti-PDL1 ATEZOLIZUMAB (MPDL3280A) or Chemotherapy as Second-line Therapy in Patients With Small Cell Lung Cancer (SCLC)

summary: Chemotherapy still constitutes the backbone of small-cell lung cancer (SCLC) therapy, particularly in the extensive disease (ED) stage (ED-SCLC). Despite the fact that a substantial complete response rate could be achieved in SCLC patients receiving etoposide - cisplatin doublet, cure remains the exception. Overall survival in patients receiving this combination is 10 months and progression free survival 6.3 months. At time of progression two options are hitherto accepted: reinduction of carboplatin - etoposide doublet or, for patients unfit for reinduction, topotecan single-drug regimen. However, in both clinical cases, median survival hardly achieves 33 weeks. Consistent data using anti - PDL1 (Programmed death-ligand 1) or anti PD1 (programmed cell death 1) antibodies suggest that they are active as single drug regimens in many malignant diseases. Taking into account the rich tumor infiltrating lymphocyte in pathological specimens of SCLC, we can hypothesize that experimental use of ATEZOLIZUMAB (MPDL3280A) in patients is ethical pending that it demonstrates activity in the second line setting.

ReferenceCitation: Negre E, Coffy A, Langlais A, Daures JP, Lavole A, Quoix E, Molinier O, Greillier L, Audigier-Valette C, Moro-Sibilot D, Westeel V, Morin F, Roch B, Pujol JL. Development and Validation of a Simplified Prognostic Score in SCLC. JTO Clin Res Rep. 2020 Feb 12;1(1):100016. doi: 10.1016/j.jtocrr.2020.100016. eCollection 2020 Mar.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
CHG de Pau
Angers - CHU
Montpellier - CHRU
APHP - Paris Bichat
Centre Hospitalier
Centre Antoine Lacassagne
GH Paris Saint-Joseph
Annemasse - CH
HCL - Lyon Sud (Pneumologie)
CHU Tours - Pneumologie
Mulhouse - CH
CHRU Grenoble
Toulouse - CHU Larrey
CH
AP-HP Hopital Tenon - Pneumologie
Rouen - CHU
Centre Hospitalier - Pneumologie
Lorient - CHBS


title: Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women.

acronym: VIGI-MESH

summary: Observatory of Materiovigilance After Surgery of Urinary Incontinence or Prolapse in Women Implantable medical devices (meshes) used in pelvic organ prolapse surgery (genital prolapse, rectal prolapse), or incontinence surgery may be source of severe complications.

lead_sponsor: Poitiers University Hospital

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

intervention_type: Procedure


title: Prospective Evaluation of Oral Alkalinization by Urologists and Nephrologists: Evolution of the Extracellular Compartment

acronym: AlcalUN

summary: Metabolic acidosis recovers a wide range of diseases in which an oral alkalinization could be useful. This therapeutic intervention has been said to increase extracellular volume leading to rising blood pressure. No prospective data has been published in clinical routine. Here, investigators propose to follow patients in which an oral alkalinization is indicated: blood pressure, body weight, and a clinical evaluation of the extracellular compartment will be performed at the beginning and during the follow-up of participants. The principal criterion of evaluation will be the variation in the extracellular compartment.

ReferenceCitation: Beaume J, Figueres L, Bobot M, de Laforcade L, Ayari H, Dolley-Hitze T, Gueutin V, Braconnier A, Golbin L, Citarda S, Seret G, Belaïd L, Cohen R, Luque Y, Larceneux F, Seervai RNH, Overs C, Bertocchio JP; Club des Jeunes Néphrologues. Sodium Bicarbonate Prescription and Extracellular Volume Increase: Real-world Data Results from the AlcalUN Study. Clin Pharmacol Ther. 2022 Jan;111(1):252-262. doi: 10.1002/cpt.2427. Epub 2021 Oct 11.

lead_sponsor: Jean-Philippe Bertocchio

location_facility: Institut Phocéen de Néphrologie, Clinique Bouchard

location_facility: E.C.H.O. (Expansion des Centres d'Hémodialyse de l'Ouest)

location_facility: La Conception University Hospital, AP-HM

location_facility: Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu


title: A Multi-centre, Multinational, Prospective Observational Registry to Collect Safety and Outcome Data in Patients Diagnosed With Severe Hepatic Veno-occlusive Disease (VOD) Following Hematopoietic Stem Cell Transplantation (HSCT) and Treated With Defitelio®

summary:
Following the licencing of a new drug, Defitelio®, indicated for the treatment of severe Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of haematopoietic stem cell transplantation (HSCT), as a specific obligation (SOB), the manufacture and marketing Authorisation Holder (MHA) (Gentium, a Jazz Pharmaceuticals Company) was required by PRAC (Pharmacovigilance Risk Assessment Committee) to set up a disease registry to collect safety and outcome data, and to assess patterns of utilization of Defitelio® in the post-approval setting. This registry is a Post Authorization Safety Study (PASS), is being coordinated in collaboration with the European Society for Blood and Marrow Transplantation (EBMT). For this study, anonymised clinical data are being collected from patients who develop VOD and and treated with and patients who have been treated with Defitelio® for conditions other than sVOD.

The study DOES NOT involve decisions about treatment, which are clinical decisions, but merely collection of data for patients who develop this complication, whether or not they receive treatment and for patients who are treated with Defitelio® for any other reasons.The study DOES NOT involve decisions about treatment, which are clinical decisions, but merely collection of data for patients who develop this complication, whether or not they receive treatment and for patients who are treated with Defitelio® for any other reasons.

ReferenceCitation: Mohty M, Battista ML, Blaise D, Calore E, Cesaro S, Maximova N, Perruccio K, Renard C, Wynn R, Zecca M, Labopin M, Hanvesakul R, Amber V, Ryan RJ, Lawson S, Ciceri F. A multicentre, multinational, prospective, observational registry study of defibrotide in patients diagnosed with veno-occlusive disease/sinusoidal obstruction syndrome after haematopoietic cell transplantation: an EBMT study. Bone Marrow Transplant. 2021 Oct;56(10):2454-2463. doi: 10.1038/s41409-021-01265-2. Epub 2021 May 31.

lead_sponsor: Jazz Pharmaceuticals

location_country:
France
Portugal
United Kingdom
Italy

location_facility: Great Ormond Street Hospital Children's Charity

location_facility: CHU Bordeaux Groupe hospitalier Pellegrin Enfants

location_facility: Clinica Ematologica-Azienda Ospedaliero Universitaria

location_facility: Policlinico G.B. Rossi, Clinica di Oncoematologia Pediatrica

location_facility: UO Oncoematologia Ospedale Pediatrico Mayer

location_facility: Ospedale Ca' Granda Ospedale Maggiore di Milano

location_facility: Istituto per l'Infanzia IRCCS Burlo Garofolo


status: Terminated

acronym: IONESCO

title: A Phase II Prospective Immune Neoadjuvant Therapy Study od Durvalumab (MEDI4736) in Early Stage Non-small Cell Lung Cancer

ReferenceCitation: Wislez M, Mazieres J, Lavole A, Zalcman G, Carre O, Egenod T, Caliandro R, Dubos-Arvis C, Jeannin G, Molinier O, Massiani MA, Langlais A, Morin F, Le Pimpec Barthes F, Brouchet L, Assouad J, Milleron B, Damotte D, Antoine M, Westeel V. Neoadjuvant durvalumab for resectable non-small-cell lung cancer (NSCLC): results from a multicenter study (IFCT-1601 IONESCO). J Immunother Cancer. 2022 Oct;10(10). pii: e005636. doi: 10.1136/jitc-2022-005636.

location_facility: Institut de Cancérologie de l'Ouest - site René Gauducheau

summary:
Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall all-stage 5-year survival of approximately 17%. The primary treatment of early stage (I-IIIA) NSCLC is curative surgery. Although patients treated with curative surgery have a better prognosis, the 5-year survival for patients treated with surgery alone remains low, ranging from 67% (stage IA) to 23% (stage IIIA). Several randomized trials comparing postoperative chemotherapy versus no chemotherapy have shown a significant overall survival benefit from postoperative chemotherapy in completely resected patients with NSCLC stage II and IIIA. Likewise other randomized trials have demonstrated preoperative chemotherapy improves survival and recently the analyses also based on individual patients data of 15 randomized trials showed a significant benefit of preoperative chemotherapy on survival with the same survival improvement of 5% at 5 years. Then, neoadjuvant chemotherapy has also become accepted in many countries.

Targeting of PD-1 receptors and its ligand PD-L1, and inhibiting their engagement is an attractive therapeutic option in the early stage NSCLC, which may reactivate host immune responses and enable longterm tumor control.


title: An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy on Chronic Pruritus in Adults With Plaque Psoriasis

acronym: PAP

summary: To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis

primary_purpose: Supportive Care

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_country: France Spain

location_facility: Centre Hospitalier de Dunkerque - Service de Dermatologie

location_facility: Hospital de la Santa Creu i Sant Pau Dept. of Dermatology

location_facility: CH de Boulogne sur Mer Hôpital DUCHENE - service de dermatologie

location_facility: CHU de Poitiers Pole régional de cancérologie Service de dermatologie

location_facility: GHRMSA Hôpital Emile Muller Service de Dermatologie

location_facility: CHU Nice - Hôpital l'Archet 1 - Centre de recherche clinique

location_facility: CHU Nantes - Unité Dermato-Cancérologie 7° nord Hotel Dieu

location_facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2


title: Assessing Long-term Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions-LEA

acronym: LEA

summary: The primary objective of this study is to evaluate long-term effectiveness of adalimumab in pediatric participants starting a treatment for Crohn's disease in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach. Main secondary objectives are to describe growth and pubertal development and to describe long-term safety. The participants will be followed-up up to 10 years.

lead_sponsor: AbbVie

location_facility: Charles Nicolle Hosp chu rouen /ID# 158688

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 154620

location_facility: CHU de Rennes - Hospital Sud /ID# 152730

location_facility: Charles Nicolle Hosp chu rouen /ID# 152670

location_facility: CHU de Besancon - Jean Minjoz /ID# 154197

location_facility: Centre Hospitalier Universitai /ID# 155465


title: CombinaiR3 - First-line Treatment of Ewing Tumours With Primary Extrapulmonary Dissemination in Patients From 2 to 50 Years

summary:
Ewing's sarcoma and related tumours (ESFT) are rare tumours, with a peak incidence in the second decade of life. They start most often from bone, and are characterized by a specific translocation involving the so-called EWS gene. In one patient out of three, the staging procedures detect metastatic tumours at the diagnosis, most commonly in lungs, bones, and bone marrow.

ESFT treatment strategy is multidisciplinary, combining primary chemotherapy, a local treatment, and consolidation chemotherapy.

The primary metastatic dissemination is the most important prognostic factor, as the survival rate is around 70-75% for localized tumours, in contrast with less than 50% for patients with primary metastatic disease.

Among primary metastatic patients, bone involvement and / or bone marrow strike markedly the prognosis of these patients. While the long-term survival of patients with isolated pleural pulmonary metastases is approximately 50%, whereas it is only from 0 to 25% in patients with bone marrow involvement.

In 1999, the Intergroup EURO EWING built a new study protocol for patients with Ewing tumours. For the patients with primary extrapulmonary metastatic Ewing tumours (R3 patients), the protocol proposed a heavy induction chemotherapy, in order to propose a consolidation with high dose chemotherapy to a higher rate of patients. The high-dose Busulfan Melphalan chemotherapy (BuMel) was based on Busulfan (600 mg/m²) and Melphalan (140 mg/m²), with autologous peripheral blood stem cell (PBSC) support.

Of note, for the full population of patients with metastatic disease, the 3-year EFS rate was 27% (SD 3%), and the OS rate was 34% (SD 4%), with a median follow-up of 3.9 years after diagnosis, and a median survival time of 1.6 years.

lead_sponsor: Institut Curie

location_facility: CHRU Montpellier - Hôpital A. de Villeneuve

location_facility: NANCY Institut de Cancérologie de Lorraine

intervention_type: Radiation


acronym: ULTIMATE

title: A Phase II Trial Testing Durvalumab Combined With Endocrine Therapy in Patients With ER+/Her2- Breast Cancer Eligible for Neoadjuvant Endocrine Therapy And Who Present CD8+ T Cell Infiltration After 4-6 Weeks Exposure to Immune-Attractant

lead_sponsor: UNICANCER

type: Other Identifier

location_country: Sweden France Spain

location_facility: Institut Daniel Hollard Groupe Hôspitalier

location_facility: Hospital Clínico Universitario de Valencia

summary: This is an open-label, multicentric, international, phase II trial testing aromatase inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (>10% CD8+ T cells in the tumor). The trial includes two sequences: The first part of the treatment will consist in 4-6 weeks treatment with immune-attractants; in the second part, CD8+ patients will receive 6 months of durvalumab combined with exemestane.


acronym: STAR

title: Comparison of Two Strategies of Glucocorticoid Withdrawal in Rheumatoid Arthritis Patients in Low Disease Activity or Remission.

type: Other Grant/Funding Number

location_facility:
Bicêtre Hospital
Saint-Etienne Hospital
Orléans Hospital
Cochin Hospital
Strasbourg Hospital
Jean Rougier Hospital
La Pitié-Salpétrière
Brest University Hospital
Bichat Hospital
Clermont-Ferrand Hospital
Montpellier Hospital
Pasteur Hospital
Hospital Pierre-Paul Riquet
Lille Hospital
Bordeaux University Hospital
Lyon Sud Hopsital
Limoges Hospital

summary: The purpose of this study is to compare the proportion of patients who could withdraw from prednisone and hydrocortisone one year after a progressive decrease of GC (GC tapering) or a hydrocortisone replacement therapy in rheumatoid arthritis in remission or low disease activity.


title: Systematic Search for Primary Immunodeficiency in Adults With Unexplained Recurrent and/or Severe Infections With Encapsulated Bacteria

acronym: SPIDAC

summary: Antibody deficiencies and complement deficiencies are the most frequent Primary immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility to recurrent and/or severe bacterial infections - especially upper and lower respiratory tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in adults. The current European and US guidelines advocate screening adults for PIDs if they present recurrent benign especially upper and lower respiratory tract infections, or if they have experienced at least two severe bacterial infections and/or have a recurrent need for intravenous antibiotics. The objective of the demonstrate the interest of PIDs screening in adult patients who present such recurrent infections and/or after the first severe bacterial infection, especially when the patients do not present with known, etiologically relevant comorbidities.

primary_purpose: Diagnostic

location_facility:
Ch Region de St-Omer
Ch Arrondissement de Montreuil
Ch Cambrai
C.H de Roubaix
Ch Armentieres
Ch de Valenciennes
Clinique Teissier
CH ARRAS
CHRU,
CH LENS
Ch Denain
Hopital Prive La Louviere
Groupe Hospitalier Seclin Carvin
Ch Tourcoing
CH DOUAI
Ch Dunkerque
Ch Boulogne-Sur-Mer
Ch Bethune
Hopital Saint Vincent - Saint Antoine

intervention_type: Biological


acronym: OPTIMA

title: Prospective, Multicenter, Open-label Study Evaluating the Effects of First-line Oral Combination Therapy of Macitentan and Tadalafil in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (OPTIMA).

lead_sponsor: Actelion

location_facility:
Hôpital Dupuytren
Hôpital Bretonneau
Hôpital de Haut Levêque
Hôpital Jean Minjoz
Hôpital Côte de Nacre
Hôpital Charles Nicolle
Hôpital Arnaud de Villeneuve
CHR La Miletrie
Hôpital Nord
Hôpital Robert Debré
Hôpital Timone Adultes
Hôpital Albert Michallon
CHU Site du Bocage
Hôpital Civil
Hôpital Larrey
Hôpital Pontchaillou
Hôpital Louis Pradel
Hôpital Bicètre

summary: The purpose of the study is to document the effect of first line dual oral combination therapy with macitentan 10mg and tadalafil 40mg on pulmonary vascular resistance (PVR) in treatment-naïve patients with newly diagnosed pulmonary arterial hypertension (PAH).


ipd_sharing: Yes

acronym: Transition II

title: An Interventional, Open-label, Single-arm, Multicenter, 24 Weeks Phase 4 Study Assessing the Efficacy and Safety of Toujeo in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin

lead_sponsor: Sanofi

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_facility:
Investigational Site Number 250050
Investigational Site Number 250082
Investigational Site Number 250034
Investigational Site Number 250073
Investigational Site Number 250107
Investigational Site Number 250105
Investigational Site Number 250021
Investigational Site Number 250048
Investigational Site Number 250056
Investigational Site Number 250053
Investigational Site Number 250092
Investigational Site Number 250026
Investigational Site Number 250075
Investigational Site Number 250032
Investigational Site Number 250089
Investigational Site Number 250058
Investigational Site Number 250062
Investigational Site Number 250042
Investigational Site Number 250083
Investigational Site Number 250007
Investigational Site Number 250095
Investigational Site Number 250004
Investigational Site Number 250067
Investigational Site Number 250041
Investigational Site Number 250001
Investigational Site Number 250005
Investigational Site Number 250102
Investigational Site Number 250012
Investigational Site Number 250035
Investigational Site Number 250051
Investigational Site Number 250064
Investigational Site Number 250061
Investigational Site Number 250022
Investigational Site Number 250063
Investigational Site Number 250104
Investigational Site Number 250059
Investigational Site Number 250054
Investigational Site Number 250037
Investigational Site Number 250093
Investigational Site Number 250033
Investigational Site Number 250055
Investigational Site Number 250024
Investigational Site Number 250023
Investigational Site Number 250069
Investigational Site Number 250017
Investigational Site Number 250030
Investigational Site Number 250096
Investigational Site Number 250039
Investigational Site Number 250100
Investigational Site Number 250046
Investigational Site Number 250008
Investigational Site Number 250076
Investigational Site Number 250020
Investigational Site Number 250108
Investigational Site Number 250028
Investigational Site Number 250101
Investigational Site Number 250065
Investigational Site Number 250070
Investigational Site Number 250047
Investigational Site Number 250098
Investigational Site Number 250018
Investigational Site Number 250060
Investigational Site Number 250081
Investigational Site Number 250044
Investigational Site Number 250088
Investigational Site Number 250010
Investigational Site Number 250043
Investigational Site Number 250029
Investigational Site Number 250031
Investigational Site Number 250071
Investigational Site Number 250057
Investigational Site Number 250002
Investigational Site Number 250087
Investigational Site Number 250006
Investigational Site Number 250084
Investigational Site Number 250019
Investigational Site Number 250103
Investigational Site Number 250052
Investigational Site Number 250068
Investigational Site Number 250027
Investigational Site Number 250013
Investigational Site Number 250090
Investigational Site Number 250072
Investigational Site Number 250078
Investigational Site Number 250086

summary:
Primary Objective:

The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement.

Secondary Objectives:

Evolution of fasting plasma glucose
Evolution of insulin dose and body weight
Hypoglycemia incidence
Safety
Patients satisfaction when they change their insulin for HOE901-U300


title: Randomized Multicenter, Phase III Trial Evaluating the Safety of 2 Schedules of Cabazitaxel (Bi-weekly Versus Tri-weekly) Plus Prednisone in Elderly Men (≥ 65years) With mCRPC Previously Treated With a Docetaxel-containing Regimen

acronym: CABASTY

summary: The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.

ReferenceCitation: Pobel C, Auclin E, Procureur A, Clément-Zhao A, Simonaggio A, Delanoy N, Vano YA, Thibault C, Oudard S. Cabazitaxel schedules in metastatic castration-resistant prostate cancer: a review. Future Oncol. 2021 Jan;17(1):91-102. doi: 10.2217/fon-2020-0672. Epub 2020 Dec 2. Review.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_country: Germany France

location_facility: Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie,

location_facility: Uniklinik Köln, Urologie, Uro-Onkologie, spezielle urologische und Roboter-assistierte Chirurgie

location_facility: Urologie und Kinderurologie Marienkrankenhaus Bergisch

location_facility: Universitäts-klinik für Urologie und Kinderurologie


acronym: ProtoTOP

title: Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) for the Treatment of Peripheral Neuropathic Pain: A Randomises, International, Multicentre, Placebo-Controlled, Phenotype-stratified Phase IIa Study

lead_sponsor: Air Liquide Santé International

ReferenceCitation: Bouhassira D, Perrot S, Attal N, Ramirez-Gil JF, Delval C, Schaller M, Bessière B, Houéto P, Sommer C. Combination of inhaled nitrous oxide and oral opioids induces long-lasting analgesic effects in patients with neuropathic pain: ProtoTOP study post hoc exploratory analyses. Pain. 2022 Sep 1;163(9):e1021-e1029. doi: 10.1097/j.pain.0000000000002570. Epub 2021 Dec 20.

ReferenceCitation: Bouhassira D, Perrot S, Riant T, Martiné-Fabre G, Pickering G, Maindet C, Attal N, Ranque Garnier S, Nguyen JP, Kuhn E, Viel E, Kieffert P, Tölle T, Delorme C, Deleens R, Giniès P, Corand-Dousset V, Dal-Col C, Serrie A, Chevrillon E, Gov C, Ramirez-Gil JF, Delval C, Schaller M, Bessière B, Houéto P, Sommer C; ProtoTOP group. Safety and efficacy of an equimolar mixture of oxygen and nitrous oxide: a randomized controlled trial in patients with peripheral neuropathic pain. Pain. 2021 Apr 1;162(4):1104-1115. doi: 10.1097/j.pain.0000000000002109.

location_facility: Neurologische Klinik Klinikum rechts der Isar

location_facility: Centre Hospitalier Universitaire Gabriel Montpied

location_facility: Centre Hospitalier Régional de Metz-Thionville

location_facility: Centre Hospitalier Regional Universitaire - Hôpital Jean-Minjoz

location_facility: Centre hospitalier Universitaire de Rouen

location_facility: Centre Hospitalier Universitaire Dupuytren

summary: To assess the effect of 3 consecutive days of one-hour administration of Nitrous Oxide/Oxygen 50%/50% (EMONO) versus placebo as Oxygen/Nitrogen 22%/78% (synthetic medical air), in add-on therapy to chronic analgesic treatments, on average pain intensity in patients with chronic peripheral neuropathic pain. A total of 250 randomised patients to be included in all the participating centres, i.e., 125 randomised patients in each of the 2 study groups treatments


title: The French Registry on the First-line Treatment of Non High-risk Acute Promyelocytic Leukemia (APL) in Patients Aged ≤ 70 Years

summary: The registry aims to compare the two first-line available treatment approaches in non-high-risk APL patients aged ≤ 70 years - ATRA plus chemotherapy and ATRA plus ATO - in terms of practitioner's choice between the two options, clinical effectiveness and cost-effectiveness, long-term outcome, and short- and long-term toxic effects.

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: CHU Hôpital Sud - service Hémato-oncologie Pédiatrique


title: OBSERVATOIRE NATIONAL D'UTILISATION D'INFLECTRA™ EN VIE RÉELLE.

acronym: ReFLECT

summary:
National, prospective, multicentre observational study designed for eligible patients treated with Inflectra.

Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the response to treatment.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_facility: Centre Hospitalier de Lille Hopital Roger Salengro

location_facility: Hopital Robert Debre, Service d'Hepato-gastro-enterologie et de Cancerologie Digestive

location_facility: Centre Hospitalier Regional de Besancon, Service de Gastrologie

location_facility: Centre Hospitalier Estaing, Service de Medicine Interne

location_facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre

location_facility: Centre Hospitalier de Cholet Service d'Hépato-Gastro-Entérologie

location_facility: Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

location_facility: Hopital Robert Debre, Service D'Hepato-gastro-enterolo

location_facility: Centre Hospitalier de Cannes Hopital Pierre Nouveau

location_facility: Centre Hospitalier Carcassonne, Service de Rhumatologie

location_facility: Fondation Maison Sante Bagatelle, Gastro Enterologie

location_facility: Centre Hospitalier de Montpellier Hopital Saint Eloi

location_facility: Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

location_facility: Service de rhumatologie - CHU Nantes, Hopital Hotel Dieu


title: Eltrombopag for the Treatment of Thrombocytopenia Due to Low- and Intermediate Risk Myelodysplastic Syndromes (EQoL-MDS)

summary:
Myelodysplastic syndromes (MDS) prevail in older age and are characterized by ineffective erythropoiesis and peripheral cytopenias. Supportive therapy is the main therapeutic option for most patients. Quality of Life (QoL) is mainly deteriorated by anemia and by the limitations associated with thrombocytopenia, neutropenia and transfusion dependence. The only available treatment for severe thrombocytopenia, in the presence of bleeding, is platelet transfusion.

Eltrombopag is an orally bioavailable agonist of the thrombopoietin receptor. In adult patients with chronic immune thrombocytopenia (ITP), Eltrombopag rapidly increases platelet counts and significantly reduces bleeding episodes during treatment. Eltrombopag is well tolerated. In 2007, Eltrombopag has received the Orphan Drug Designation for the treatment of ITP (EMEA/OD/031/07), and in 2008 the Food and Drug Association approved Eltrombopag for the treatment of ITP refractory or resistant. It has been shown that in patients affected by MDS and by acute myeloid leukemia, Eltrombopag neither increases the proliferation, nor the clonogenic growth capacity of bone marrow blasts. Furthermore, Eltrombopag induces an increase in the megakaryocytic differentiation and in the formation of normal megakaryocytic colonies. These results provide the rationale for pursuing further research on Eltrombopag for the treatment of thrombocytopenia in case of MDS.

The study is open to adult patients with myelodysplastic syndrome (MDS) with thrombocytopenia and low- or intermediate-1 IPSS risk (Index Prognostic Score System).

Severe thrombocytopenia associated with MDS may lead to death from hemorrhage, even in low prognostic risk patients. The benefit of platelet transfusion is short-termed. Patients become refractory in the long term. The availability of a treatment that induces the increase of platelet count is extremely important, either in terms of quality of life, and in overall survival.

lead_sponsor: Associazione Qol-one

location_country: Germany France Slovenia Italy

location_facility: A.O.U. San Giovanni di Dio e Ruggì D'Aragona

location_facility: U.O. Citta' della Salute e della Scienza di Torino

location_facility: Centre Hospitalier Universitaire de Nimes

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: A.O. Citta' della Salute e della Scienza di Torino

location_facility: A.O. SS. Antonio e Biagio e Cesare Arrigo


title: Safety and Efficacy of tocilizuMAb Versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence SEMAPHORE

summary:
Patients are treated with infusions of Tocilizumab (TCZ) or placebo for 5 months. Clinical evaluation is performed using PMR-AS.

The PMR-AS is computed by summing the 5 variables after multiplying by 0.1 for weighting purposes: PMR-AS (activity scale = AS) = C reactive protein (CRP) (mg/dl) + patient scale (VASp) (0-10 scale) + physician scale (VASph) (0-10 scale) + morning stiffness(MST) [min]×0.1) + elevation of upper limbs (EUL) (0-3 scale).

All the patients included are treated with glucocorticoid (GC).GC are reduced at each visit until the end of the study, depending on response to treatment and PMR-AS.

ReferenceCitation: Devauchelle-Pensec V, Carvajal-Alegria G, Dernis E, Richez C, Truchetet ME, Wendling D, Toussirot E, Perdriger A, Gottenberg JE, Felten R, Fautrel BJ, Chiche L, Hilliquin P, Le Henaff C, Dervieux B, Direz G, Chary-Valckenaere I, Cornec D, Guellec D, Marhadour T, Nowak E, Saraux A. Effect of Tocilizumab on Disease Activity in Patients With Active Polymyalgia Rheumatica Receiving Glucocorticoid Therapy: A Randomized Clinical Trial. JAMA. 2022 Sep 20;328(11):1053-1062. doi: 10.1001/jama.2022.15459.

lead_sponsor: University Hospital, Brest

location_facility: Hopital Nord service de rhumatologie-Franche Comté


title: Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice

acronym: MIROIR

summary:
This study, a national, multicenter, observational, ambispective, non-interventional study, will be conducted in French hospitals prescribing pomalidomide and already participating in the ongoing Imnovid registry.

This study will add to the registry. Indeed, pomalidomide-prescribing physicians and pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who have been prescribed this drug since the date on which it was marketed regardless of the initiation date of pomalidomide or the indication for which it was prescribed.

ReferenceCitation: Waldschmidt JM, Simon A, Wider D, Müller SJ, Follo M, Ihorst G, Decker S, Lorenz J, Chatterjee M, Azab AK, Duyster J, Wäsch R, Engelhardt M. CXCL12 and CXCR7 are relevant targets to reverse cell adhesion-mediated drug resistance in multiple myeloma. Br J Haematol. 2017 Oct;179(1):36-49. doi: 10.1111/bjh.14807. Epub 2017 Jul 2.

ReferenceCitation: Dinner S, Dunn TJ, Price E, Coutré SE, Gotlib J, Berube C, Kaufman GP, Medeiros BC, Liedtke M. A phase I, open-label, dose-escalation study of amrubicin in combination with lenalidomide and weekly dexamethasone in previously treated adults with relapsed or refractory multiple myeloma. Int J Hematol. 2018 Sep;108(3):267-273. doi: 10.1007/s12185-018-2468-5. Epub 2018 May 25.

ReferenceCitation: Garderet L, Kuhnowski F, Berge B, Roussel M, Escoffre-Barbe M, Lafon I, Facon T, Leleu X, Karlin L, Perrot A, Moreau P, Marit G, Stoppa AM, Royer B, Chaleteix C, Tiab M, Araujo C, Lenain P, Macro M, Voog E, Benboubker L, Allangba O, Jourdan E, Orsini-Piocelle F, Brechignac S, Eveillard JR, Belhadj K, Wetterwald M, Pegourie B, Jaccard A, Eisenmann JC, Glaisner S, Mohty M, Hulin C, Loiseau HA, Mathiot C, Attal M. Pomalidomide, cyclophosphamide, and dexamethasone for relapsed multiple myeloma. Blood. 2018 Dec 13;132(24):2555-2563. doi: 10.1182/blood-2018-07-863829. Epub 2018 Oct 3.

ReferenceCitation: Mark TM, Forsberg PA, Rossi AC, Pearse RN, Pekle KA, Perry A, Boyer A, Tegnestam L, Jayabalan D, Coleman M, Niesvizky R. Phase 2 study of clarithromycin, pomalidomide, and dexamethasone in relapsed or refractory multiple myeloma. Blood Adv. 2019 Feb 26;3(4):603-611. doi: 10.1182/bloodadvances.2018028027.

ReferenceCitation: Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.

ReferenceCitation: Li Y, Wang X, Liu L, Zhang C, Gomez D, Reyes J, Palmisano M, Zhou S. An Open-Label, Phase 1 Study to Assess the Effects of Hepatic Impairment on Pomalidomide Pharmacokinetics. Clin Pharmacol Drug Dev. 2019 Apr;8(3):346-354. doi: 10.1002/cpdd.470. Epub 2018 May 10.

lead_sponsor: Celgene

location_facility: Hopital Nord Franche-Comte - Site de Belfort

location_facility: Centre Hospitalier Intercommunal Robert Ballanger


title: The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest

acronym: CP-GARO

summary: Intra-aortic Balloon Pumps (IABP) have been used for roughly 50 years in Critical Care Units, Intensive Care Units, Cath labs as a way to improve systemic and coronary circulation in patients in cardiogenic shock (CS) or at high risk situation as mechanical complications stemming from myocardial infarction (MI), critical coronary stenosis, high-risk PCI, etc. Several papers recently questioned the relevance of this assistance device - namely the IABP-SHOCK II trial in CS and the CRISP-AMI trial in anterior MI without CS - resulting in the downgrading of the recommendation standards of the IABP by medical societies.

lead_sponsor: Rennes University Hospital

location_facility: Groupement Coopération Sanitaire Pui Cite Sanitaire

location_facility: Communauté Hospitalière de Territoire Rance Emeraude


title: Evaluation of the Clinical Benefit of a Spa Care on the Evolution of Late Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission

acronym: FIBROTHERME

summary: This study evaluates the dermatological life quality six months after spa cares in patients with severe late toxicity involving the skin and / or soft tissues after postoperative radiotherapy for breast cancer. Half of the patients will be treated with a combination of pentoxifylline (PTX) and alpha-tocopherol (Vit E) when Half of the patients will receive skin-oriented spa cares in addition.

study_start_date_type: Anticipated

lead_sponsor: Institut de Cancérologie de Lorraine

location_facility: CH de Belfort-Montbéliard Site du Mittan

location_facility: Clinique du Parc de Charleville-Mézières

location_facility: Centre d'Oncologie et de Radiothérapie du Parc


title: A Prospective Randomized Phase II Study Evaluating the Monitoring of Imatinib Mesylate (Glivec®) Plasmatic Through Level in Patients Newly Diagnosed With Chronic Phase Chronic Myelogenous Leukaemia (CP-CML).

acronym: OPTIMIMATINIB

summary:
Imatinib mesylate (Gleevec/Glivec, IM) is currently the gold standard or CML-CP front line therapy. The recommended dose of IM is 400 mg/day. The rates of complete cytogenetic responses at 3, 6 and 12 months are 27%, 50% and 69% respectively. The optimal IM daily dose is not yet determined and randomized studies addressing this question are on-going. First results from the TOPS trial (EHA 2008 congress) suggest a more rapid kinetic of response for patients treated with imatinib high dose. Recent studies revealed that initial Imatinib plasmatic dosage is predictive for achieving complete cytogenetic responses (CCR) and that a dosage of 1000 ng/ml is associated with a higher proportion of major molecular responses (MMR) (Picard et al., Blood 2007, Larson et al. Blood 2007).

Results from the study of Larson et al. indicate that around 40% of the patients had a trough plasmatic level below 1000 ng/ml after day 28 of imatinib 400 mg/d. The major molecular response rate at 12 months for the patients with the lower plasmatic through level is 25.4% compared to 40.1% for the patients with a plasmatic dosage over 800 to 1000 ng/ml.

Investigators propose to adapt the imatinib daily dose in case of imatinib through plasmatic level at day 28 below 1000 ng/ml. Patients with a trough plasmatic dosage ≤ 1000 ng/ml will be randomized between a prospective adaptation strategy of the imatinib daily dose (cohort 1) versus observation only (cohort 2). The patients with adequate imatinib dosage (> 1000 ng/ml) will be followed up according the ELN recommendation (cohort 3). Imatinib trough plasmatic level will then be rechecked every month thereafter for patients in cohort 1 and cohort 2 and every three months in cohort 3. The first endpoint of the study will be the rate of major molecular response at 12 months in cohort 1. Our hypothesis is to improve the 12 months MMR rate with the optimized strategy (cohort 1) from 25% of MMR at 12 months to 40% of MMR at 12 months.

lead_sponsor: Versailles Hospital

location_facility:
Institut Bergonié
CH de Dieppe
CHU Lyon
CH Dunkerque
CH Versailles
CHU Lille
CHU Bordeaux
Hopital Bon secours
Hopital La Source
CHU Rennes
CHU CAEN
CH argenteuil
Hopital Necker
CH Meaux
CH Boulogne
CHU Nice
Hopital Purpan
CHU angers
CH d'Annecy


title: Follow-up of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia

acronym: STIM-FU

summary: It's an observational study based on 98 patients included in the STIM trial to extend the monitoring of patients and to have molecular and clinical data, with long follow up. Are there late relapses? What has become patients who relapsed during STIM trial and restarted TKI (inhibitor tyrosine kinase) treatment?

lead_sponsor: University Hospital, Bordeaux

location_facility:
Institut Bergonié
Hôpital Henri-Mondor
Hôpital Edouard Herriot
CHU de Nice
Hôpital Morvan
Institut Paoli Calmette
Pôle de cancérologie
Hôpital Necker-Enfants Malades
CHU Brabois
CHU d'Angers
Hôpital Saint Louis
CHU de Poitiers
Hôpital Purpan
CHU de Bordeaux - Haut-Lévêque
Centre Hospitalier de La Roche Sur Yon
Hôpital Claude Huriez
Hôpital Civil
Centre Hospitalier de Versailles
CHU Hôtel-Dieu

intervention_type: Behavioral


title: Phase II Study to Evaluate the Efficacy of Upfront Obinutuzumab in Mantle Cell Lymphoma Patients Treated by DHAP Followed by Autologous Transplantation Plus Obinutuzumab Maintenance Then MRD Driven Maintenance

summary: This study is a multicentric, single arm phase II trial to evaluate the efficacy of upfront obinutuzumab in mantle cell lymphoma patients treated by Cisplatinum-Cytarabine-Dexamethasone (DHAP) followed by autologous transplantation plus obinutuzumab maintenance then Molecular Residual Disease (MRD) driven maintenance

ReferenceCitation: Le Gouill S, Beldi-Ferchiou A, Alcantara M, Cacheux V, Safar V, Burroni B, Guidez S, Gastinne T, Canioni D, Thieblemont C, Maisonneuve H, Bodet-Milin C, Houot R, Oberic L, Bouabdallah K, Bescond C, Damaj G, Jaccard A, Daguindau N, Moreau A, Tilly H, Ribrag V, Delfau-Larue MH, Hermine O, Macintyre E. Molecular response after obinutuzumab plus high-dose cytarabine induction for transplant-eligible patients with untreated mantle cell lymphoma (LyMa-101): a phase 2 trial of the LYSA group. Lancet Haematol. 2020 Nov;7(11):e798-e807. doi: 10.1016/S2352-3026(20)30291-X. Epub 2020 Sep 21.

ReferenceCitation: Bailly C, Carlier T, Berriolo-Riedinger A, Casasnovas O, Gyan E, Meignan M, Moreau A, Burroni B, Djaileb L, Gressin R, Devillers A, Lamy T, Thieblemont C, Hermine O, Kraeber-Bodéré F, Le Gouill S, Bodet-Milin C. Prognostic value of FDG-PET in patients with mantle cell lymphoma: results from the LyMa-PET Project. Haematologica. 2020 Jan;105(1):e33-e36. doi: 10.3324/haematol.2019.223016. Epub 2019 Aug 1.

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
Clinique Victor Hugo
CHU Robert Debré
CHU de Clermont Ferrand
CHU Pontchaillou
Institut de Cancérologie de Loire
APHP - Hopital Necker
CHU de Caen
CHU de Dijon - Hôpital le Bocage
CHU de Strasbourg
I.U.C.T Oncopole
CHU de Haut Leveque
CHRU Bretonneau
CH Perpignan
CH d'Avignon
Hôpital Saint Louis
CHU de Brabois
CHD Vendée
CHRU Lille - Hôpital Claude Huriez
Gustave Roussy Cancer Campus
Centre Hospitalier Annecy-Genevois
CHU Nantes
CHU d'Amiens
Hopital Henri Mondor
CHU Lyon Sud
CHU Montpellier
CHU d'Angers
CHU de Grenoble
CHU de Poitiers
CHU Limoges
Centre Henri Becquerel


title: Evaluation of an Active Swallowing Rehabilitation on Quality of Life of Patients Treated by Radiotherapy for Head and Neck Cancer

acronym: RORC

summary:
Toxicity and mainly dysphagia have increased in head and neck cancers as chemoradiation indications have risen over the last decade, leading to a significant loss of quality of life for patients. Recently, many retrospective studies and two evidence-based and systematic reviews on strategies to reduce radiation-induced dysphagia have suggested a trend toward benefit for a preventive swallowing exercise program.

The main hypothesis of this study is that an early active swallowing therapy can improve the Quality of Life (QoL) of patients treated by radiotherapy for head and neck cancer.

The study will be a randomized controlled, open-label, multicentric phase III clinical trial comparing early active swallowing therapy versus non specific swallowing management (usual care).

location_facility:
Lille University Hospital
Centre François Baclesse
Poitiers University Hospital
Centre Antoine Lacassagne
Brest University Hospital
Tenon Hospital
Marseille University Hospital
Institut Gustave Roussy
Strasbourg University Hospital
Toulouse University Hospital
Le Mans Hospital
Caen University Hospital
Nantes University Hospital
Clinique La Sagesse
Centre Alexis Vautrin
Bretagne Atlantique Hospital
Bretagne Sud Hospital
Tours University Hospital
Rennes University Hospital
Lyon University Hospital
Clermont-Ferrand University Hospital


title: Interest of Implantable Cardioverter-defibrillator in Primary Prevention in Patient With Continuous Flow Left Ventricular Assist Device (CF-LVAD)

acronym: ASSIST-ICD

summary: Determination of risk factors of ventricular arrhythmias (VAs) after implantation of continuous flow left ventricular assist device in order to characterize which patient requires ICD implantation in primary prevention.

ReferenceCitation: Charton M, Flécher E, Leclercq C, Delmas C, Dambrin C, Goeminne C, Vincentelli A, Michel M, Lehelias L, Verdonk C, Para M, Pozzi M, Obadia JF, Boignard A, Chavanon O, Barandon L, Nubret K, Kindo M, Minh TH, Gaudard P, Pelcé E, Gariboldi V, Litzler PY, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Bourguignon T, Genet T, Eschalier R, D'Ostrevy N, Bories MC, Jouan J, Vanhuyse F, Blangy H, Doucerain J, Martins RP, Galand V. Suicide Attempts Among LVAD Recipients: Real-Life Data From the ASSIST-ICD Study. Circulation. 2020 Mar 17;141(11):934-936. doi: 10.1161/CIRCULATIONAHA.119.041910. Epub 2020 Mar 10.

ReferenceCitation: Galand V, Flécher E, Auffret V, Pichard C, Boulé S, Vincentelli A, Rollin A, Mondoly P, Barandon L, Pernot M, Kindo M, Cardi T, Gaudard P, Rouvière P, Sénage T, Jacob N, Defaye P, Chavanon O, Verdonk C, Ghodbane W, Pelcé E, Gariboldi V, Pozzi M, Obadia JF, Savouré A, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Pierre B, Bourguignon T, Eschalier R, D'Ostrevy N, Bories MC, Marijon E, Vanhuyse F, Blangy H, Verhoye JP, Leclercq C, Martins RP. Early Ventricular Arrhythmias After LVAD Implantation Is the Strongest Predictor of 30-Day Post-Operative Mortality. JACC Clin Electrophysiol. 2019 Aug;5(8):944-954. doi: 10.1016/j.jacep.2019.05.025. Epub 2019 Aug 19.

ReferenceCitation: Martins RP, Leclercq C, Bourenane H, Auffret V, Boulé S, Loobuyck V, Dambrin C, Mondoly P, Sacher F, Bordachar P, Kindo M, Cardi T, Gaudard P, Rouvière P, Michel M, Gourraud JB, Defaye P, Chavanon O, Kerneis C, Ghodhbane W, Pelcé E, Gariboldi V, Pozzi M, Grinberg D, Litzler PY, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Pierre B, Bourguignon T, Eschallier R, D'Ostrevy N, Bories MC, Jouan J, Vanhuyse F, Sadoul N, Flécher E, Galand V. Incidence, predictors, and clinical impact of electrical storm in patients with left ventricular assist devices: New insights from the ASSIST-ICD study. Heart Rhythm. 2019 Oct;16(10):1506-1512. doi: 10.1016/j.hrthm.2019.06.021. Epub 2019 Jun 27.

ReferenceCitation: Tattevin P, Flécher E, Auffret V, Leclercq C, Boulé S, Vincentelli A, Dambrin C, Delmas C, Barandon L, Veniard V, Kindo M, Cardi T, Gaudard P, Rouvière P, Sénage T, Jacob N, Defaye P, Chavanon O, Verdonk C, Para M, Pelcé E, Gariboldi V, Pozzi M, Grinberg D, Savouré A, Litzler PY, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Lellouche N, Bernard L, Bourguignon T, Eschalier R, D'Ostrevy N, Jouan J, Varlet E, Vanhuyse F, Blangy H, Martins RP, Galand V. Risk factors and prognostic impact of left ventricular assist device-associated infections. Am Heart J. 2019 Aug;214:69-76. doi: 10.1016/j.ahj.2019.04.021. Epub 2019 May 6.

ReferenceCitation: Galand V, Flécher E, Auffret V, Boulé S, Vincentelli A, Dambrin C, Mondoly P, Sacher F, Nubret K, Kindo M, Cardi T, Gaudard P, Rouvière P, Michel M, Gourraud JB, Defaye P, Chavanon O, Verdonk C, Ghodbane W, Pelcé E, Gariboldi V, Pozzi M, Obadia JF, Litzler PY, Anselme F, Babatasi G, Belin A, Garnier F, Bielefeld M, Hamon D, Radu C, Pierre B, Bourguignon T, Eschalier R, D'Ostrevy N, Bories MC, Marijon E, Vanhuyse F, Blangy H, Verhoye JP, Leclercq C, Martins RP; ASSIST-ICD Investigators. Predictors and Clinical Impact of Late Ventricular Arrhythmias in Patients With Continuous-Flow Left Ventricular Assist Devices. JACC Clin Electrophysiol. 2018 Sep;4(9):1166-1175. doi: 10.1016/j.jacep.2018.05.006. Epub 2018 Jul 25.

location_facility: Hospices Civils de Lyon - Hôpital Louis Pradel


title: Adjuvant Treatment in Extensive Unilateral Retinoblastoma Primary Enucleated

summary: Postoperative Treatment of Unilateral Retinoblastoma After Primary Enucleation according to histopathological risk factors of the International Retinoblastoma Staging Working Group.

location_facility:
Chr Felix Guyon
Hopital Nord Chu Amiens
Chu Bocage
Chu Morvan
Hopital D'Enfants La Timone
Centre Oscar Lambret
Hopital Arnaud de Villeneuve
Hoptial Hautepierre
Chu R; Pellegrin
Chu Nancy
Chu Estaing
CHU CAEN
Chu Nantes
Hopital Jean Minioz
Chu Saint Etienne
Chur de Reims
Chu Angers
Chu de Grenoble
Institut Curie
Chu Toulouse
Chu Limoges
Chu de Poitiers
Chu de Rennes
Chu de Nice
Chu de Rouen
Chu Tours
Centre Leon Berard


acronym: EFESE

summary:
Despite advances in early detection and treatment strategy, about 25 to 40% of patients treated for breast cancer develop metastasis.

Some patients are in a therapeutic impasse situation. It is therefore necessary to consider all possible options. The Estramustine showed encouraging results in the treatment of metastatic breast cancer.

Given the clinical data, the answer rate of Estramustine and its impact on progression free survival deserve to be studied in earlier clinical situation.

This Phase II study evaluated the efficacy of Estramustine in women with breast cancer and metastates, already treated with aromatase inhibitors and for whom this treatment has failed.

location_facility:
Institut Jean Godinot
Centre Paul Strauss
Centre O. Lambret
CLCC Léon Bérard
Clinique Sainte Anne
CLCC Val d'Aurel
Polyclinique de Blois
Centre Antoine Lacassagne
Polyclinique Bordeaux Nord Aquitaine
Polyclinique Courlancy Reims
Clinique armoricaine
Institut de Cancérologie de Lorraine
CHU Avicenne
CHU Besançon-Jean Minjoz
Hôpital Européen Georges Pompidou
Hôpital Privé Clairval
Institut Sainte Catherine
CHBM Site du Mittan
Centre Catherine de Sienne
CHRU Brest
CHU Tenon


title: Apomorphine Pump in Early Stage of Parkinson's Disease

acronym: EARLY-PUMP

summary: The aim of the study is to assess the use of the apomorphine pump in earlier stages of Parkinson' Disease (PD), when motor complications have just developed and before patients are significantly affected in their social and occupational functioning. The investigators hypothesize that apomorphine pump is superior in terms of positive impact on quality of life (QoL) to oral medical therapy alone at a relatively early stage of PD, before the appearance of severe disabling motor complications thus favoring the maintain of patients' social and occupational status with a significant positive economic impact of the health system.

location_facility: Groupe Hospitalier Régional de Mulhouse et Sud Alsace


title: Identification of Genetic Markers Modulating Rhythmic Risk Among Patients With Severe Cardiomyopathy

acronym: GENECHOC

summary: The aim of this project is to identify common genetic polymorphisms associated with the occurrence of rhythmic events in patients with severe cardiomyopathy.

time_perspective: Other

lead_sponsor: Nantes University Hospital

location_facility:
CHU Nantes
CHU Tours
CHU Lyon
CHU Montpellier
CHU Angers
CHU Bordeaux
CHU Brest
CHU Rennes
CHU Rouen
CHU Nancy
CHU Grenoble
CHU Marseille
CHRU Lille
CHRU Strasbourg
CHU Toulouse
CHU Clermont-Ferrand.
CHU Dijon
CH La Rochelle

intervention_type: Genetic


title: An Open-Label, Multicenter, Randomized, Phase II Study to Evaluate the Efficacy and Safety of Two Combination Dose Regimens: Capecitabine + Epirubicin + Cyclophosphamide (CEX) Versus 5-FU + Epirubicin + Cyclophosphamide (FEC 100) as Neoadjuvant Therapy in Females Presenting With Operable Breast Cancer

summary: This study will evaluate the efficacy and safety of treatment with oral capecitabine or intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide, prior to surgery in participants with breast cancer. The participants will receive 4 cycles of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin + Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85). After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast surgery with regional lymph node dissection will be performed, followed within a maximum of 6 weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m^2) by IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period, participants will enter the post-treatment follow-up period which will last for 5 years from the initial date of participant randomization. During this period participants will be evaluated once a year on the anniversary date of randomization.

lead_sponsor: Hoffmann-La Roche