title: Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy

acronym: PASAPAS

summary:
Breast cancer is the most common cancer in women. Weight gain in adulthood, overweight or obesity, physical inactivity and alcohol consumption are risk factors commonly associated with risk of breast cancer (mainly for post-menopausal for overweight and obesity). Reduced physical activity is one factor likely to weight gain in women after adjuvant chemotherapy for localized breast cancer. Furthermore, physical activity appropriately could improve many prognostic factors and survival of women after breast cancer. Adapted Physical Activity (APA) could improve fitness, quality of life, body image, treatment compliance and reduce fatigue.

After diagnosis of breast cancer, there is many possible risk factors of mortality or morbidity related to nutritional factors available to management. These risks prevention through management of these patients appears indispensable through an APA program.

Thus, the investigators propose to test the feasibility of implementing a program of dietary intervention and APA to prevent the risk of weight gain (which affects more than half of patients) and maintain and/or increase their level of physical activity during and after adjuvant chemotherapy.

ReferenceCitation: Majed B, Moreau T, Senouci K, Salmon RJ, Fourquet A, Asselain B. Is obesity an independent prognosis factor in woman breast cancer? Breast Cancer Res Treat. 2008 Sep;111(2):329-42. doi: 10.1007/s10549-007-9785-3. Epub 2007 Oct 16.

ReferenceCitation: Tredan O, Bajard A, Meunier A, Roux P, Fiorletta I, Gargi T, Bachelot T, Guastalla JP, Lallemand Y, Faure C, Perol D, Bachmann P. Body weight change in women receiving adjuvant chemotherapy for breast cancer: a French prospective study. Clin Nutr. 2010 Apr;29(2):187-91. doi: 10.1016/j.clnu.2009.08.003. Epub 2009 Aug 26.

ReferenceCitation: Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86. doi: 10.1001/jama.293.20.2479.

ReferenceCitation: Newton RU, Galvao DA. Exercise in prevention and management of cancer. Curr Treat Options Oncol. 2008 Jun;9(2-3):135-46. doi: 10.1007/s11864-008-0065-1. Epub 2008 Aug 13.

ReferenceCitation: Pierce JP, Stefanick ML, Flatt SW, Natarajan L, Sternfeld B, Madlensky L, Al-Delaimy WK, Thomson CA, Kealey S, Hajek R, Parker BA, Newman VA, Caan B, Rock CL. Greater survival after breast cancer in physically active women with high vegetable-fruit intake regardless of obesity. J Clin Oncol. 2007 Jun 10;25(17):2345-51. doi: 10.1200/JCO.2006.08.6819.

ReferenceCitation: Febvey-Combes O, Jobard E, Rossary A, Pialoux V, Foucaut AM, Morelle M, Delrieu L, Martin A, Caldefie-Chezet F, Touillaud M, Berthouze SE, Boumaza H, Elena-Herrmann B, Bachmann P, Tredan O, Vasson MP, Fervers B. Effects of an Exercise and Nutritional Intervention on Circulating Biomarkers and Metabolomic Profiling During Adjuvant Treatment for Localized Breast Cancer: Results From the PASAPAS Feasibility Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:1534735420977666. doi: 10.1177/1534735420977666.

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

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

publisher_dissemination: SAGE Publications

ReferenceCitation: Perrier L, Foucaut AM, Morelle M, Touillaud M, Kempf-Lepine AS, Heinz D, Gomez F, Meyrand R, Baudinet C, Berthouze S, Reynes E, Carretier J, Guillemaut S, Perol D, Tredan O, Philip T, Bachmann P, Fervers B. Cost-effectiveness of an exercise and nutritional intervention versus usual nutritional care during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer. 2020 Jun;28(6):2829-2842. doi: 10.1007/s00520-019-05078-4. Epub 2019 Nov 15.

ReferenceCitation: Foucaut AM, Morelle M, Kempf-Lepine AS, Baudinet C, Meyrand R, Guillemaut S, Metzger S, Bourne-Branchu V, Grinand E, Chabaud S, Perol D, Carretier J, Berthouze SE, Reynes E, Perrier L, Rebattu P, Heudel PE, Bachelot T, Bachmann P, Fervers B, Tredan O, Touillaud M. Feasibility of an exercise and nutritional intervention for weight management during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer. 2019 Sep;27(9):3449-3461. doi: 10.1007/s00520-019-4658-y. Epub 2019 Jan 24.

collaborators: Association Lyonnaise de Logistique Posthospitalière


type: EudraCT Number

type: Other Identifier

title: Single-arm, Multicentre, Phase II Study of Immunotherapy in Patients With Type B3 Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy

acronym: NIVOTHYM

summary: The aim of the phase II Nivothym study is to collect data on activity and toxicity of nivolumab therapy in patients with thymic carcinoma or type B3 thymoma that previously received a first platinum-based chemotherapy.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Remon J, Girard N, Novello S, de Castro J, Bigay-Game L, Bernabe R, Greillier L, Mosquera J, Cousin S, Juan O, Sampayo M, Besse B. PECATI: A Multicentric, Open-Label, Single-Arm Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab and Lenvatinib in Pretreated B3-Thymoma and Thymic Carcinoma Patients. Clin Lung Cancer. 2022 May;23(3):e243-e246. doi: 10.1016/j.cllc.2021.07.008. Epub 2021 Jul 20.

oa_host_type: repository

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

host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Universidad de Sevilla - idUS

version: publishedVersion

unpaywall_oa_status: green

publisher_dissemination: Elsevier

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

location_country:
United Kingdom
Switzerland
Netherlands
Belgium
Spain
France

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Royal Marsden Hospital - Chelsea, London

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Assistance Publique - Hopitaux de Marseille - Hopital Nord (APHM)

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Multicentre Validation of a Fetal Urine Peptidome-based Classifier to Predict Post-natal Renal Function in Posterior Urethral Valves

acronym: Antenatal

summary: Validate the use of fetal urine peptidome-analysis and explore amniotic fluid markers for the stratification of fetuses with Posterior Urethral Valve for post-natal renal function.

status: Recruiting

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Hogan J, Dourthe ME, Blondiaux E, Jouannic JM, Garel C, Ulinski T. Renal outcome in children with antenatal diagnosis of severe CAKUT. Pediatr Nephrol. 2012 Mar;27(3):497-502. doi: 10.1007/s00467-011-2068-6. Epub 2011 Dec 14.

ReferenceCitation: Seeds JW. Diagnostic mid trimester amniocentesis: how safe? Am J Obstet Gynecol. 2004 Aug;191(2):607-15. doi: 10.1016/j.ajog.2004.05.078.

ReferenceCitation: Clark TJ, Martin WL, Divakaran TG, Whittle MJ, Kilby MD, Khan KS. Prenatal bladder drainage in the management of fetal lower urinary tract obstruction: a systematic review and meta-analysis. Obstet Gynecol. 2003 Aug;102(2):367-82. doi: 10.1016/s0029-7844(03)00577-5.

ReferenceCitation: Morris RK, Malin GL, Quinlan-Jones E, Middleton LJ, Hemming K, Burke D, Daniels JP, Khan KS, Deeks J, Kilby MD; Percutaneous vesicoamniotic shunting in Lower Urinary Tract Obstruction (PLUTO) Collaborative Group. Percutaneous vesicoamniotic shunting versus conservative management for fetal lower urinary tract obstruction (PLUTO): a randomised trial. Lancet. 2013 Nov 2;382(9903):1496-506. doi: 10.1016/S0140-6736(13)60992-7. Epub 2013 Aug 14.

ReferenceCitation: Schmoor C, Sauerbrei W, Schumacher M. Sample size considerations for the evaluation of prognostic factors in survival analysis. Stat Med. 2000 Feb 29;19(4):441-52. doi: 10.1002/(sici)1097-0258(20000229)19:43.0.co;2-n.

ReferenceCitation: Lijmer JG, Mol BW, Heisterkamp S, Bonsel GJ, Prins MH, van der Meulen JH, Bossuyt PM. Empirical evidence of design-related bias in studies of diagnostic tests. JAMA. 1999 Sep 15;282(11):1061-6. doi: 10.1001/jama.282.11.1061. Erratum In: JAMA 2000 Apr 19;283(15):1963.

ReferenceCitation: Rutjes AW, Reitsma JB, Di Nisio M, Smidt N, van Rijn JC, Bossuyt PM. Evidence of bias and variation in diagnostic accuracy studies. CMAJ. 2006 Feb 14;174(4):469-76. doi: 10.1503/cmaj.050090.

ReferenceCitation: Donders AR, van der Heijden GJ, Stijnen T, Moons KG. Review: a gentle introduction to imputation of missing values. J Clin Epidemiol. 2006 Oct;59(10):1087-91. doi: 10.1016/j.jclinepi.2006.01.014. Epub 2006 Jul 11.

ReferenceCitation: Klein J, Lacroix C, Caubet C, Siwy J, Zurbig P, Dakna M, Muller F, Breuil B, Stalmach A, Mullen W, Mischak H, Bandin F, Monsarrat B, Bascands JL, Decramer S, Schanstra JP. Fetal urinary peptides to predict postnatal outcome of renal disease in fetuses with posterior urethral valves (PUV). Sci Transl Med. 2013 Aug 14;5(198):198ra106. doi: 10.1126/scitranslmed.3005807.

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_country:
Germany
Italy
Poland
United Kingdom
Netherlands
Switzerland
Belgium
Spain
France

location_facility: Hôpital des Enfants Hôpitaux universitaire Genève (HUG)

location_facility: Centre hospitalier universitaire Chu Amiens Salouël Hôpital sud

location_facility: Centre Olympe de Gouges du CHRU de Tours

location_facility: Hôpital Paule de Viguier-Hôpital des enfants- Site Purpan

location_facility: Leiden University Medical Center Dept of prenatal diagnosis and therapy

location_facility: Polish Mothers Memorial Hospital Research Institute

location_facility: CHU de Grenoble - Hôpital Couple-Enfant - Département de la Génétique

location_facility: FetalMedicine Centre Birmingham Women's Hospital

location_facility: Hôpital Bagatelle (Talence) - CHU Pellegrin (Bordeaux)

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico

lead_sponsor_type: academique


title: Assessment of the Effect of Cow's Milk Protein-based Formulas for Infants in the Management of Moderate to Severe aTOPic Dermatitis in Infants Aged Less Than 18 Months

summary: The aim of this study is to show the efficiency of a new infant formula containing fiber on the management of moderate to severe atopic dermatitis.

design_allocation: Randomized

lead_sponsor: United Pharmaceuticals

location_country: Belgium France

intervention_type: Dietary Supplement


acronym: OBILUP

lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary:
This is a randomised, open label, controlled non-inferiority phase III multicentre trial.

As primary objective, the study aims to demonstrate that a regimen free of additional oral corticosteroids but with obinutuzumab (and MMF) is non-inferior to a regimen based on oral corticosteroids and MMF in achieving the primary outcome of complete renal response at week 52 without receiving corticosteroids above a prespecified dose.

As secondary objectives, the study aims:

To compare the efficacy of the treatments in both arms in terms of:

partial plus complete renal response at week 52;
proteinuria < 0.8g/g at week 52;
extrarenal flares;
response as defined by a >4 points reduction in SELENA-SLEDAI score at week 52.

To compare the safety of the treatments in both arms in terms of occurrence of:

toxicity of corticosteroids;
serious Adverse Events;
serious Infectious Episodes;
new damage.
To compare the number of patients with non-adherence to treatment in both arms.
To estimate the efficiency of obinutuzumab in this indication.

The ancillary studies will allow:

To implement a biobank (serum, plasma, DNA, cells and urine) and a bank of renal biopsies for studies that will be part of separate research funding bids (patients will be informed that their samples and data may be used for subsequent studies and offered to consent or not).
To identify which target therapeutic levels of MMF best predicts response with least toxicity (ancillary study).
To have long term data on renal function and damage.

ReferenceCitation: Tunnicliffe DJ, Palmer SC, Henderson L, Masson P, Craig JC, Tong A, Singh-Grewal D, Flanc RS, Roberts MA, Webster AC, Strippoli GF. Immunosuppressive treatment for proliferative lupus nephritis. Cochrane Database Syst Rev. 2018 Jun 29;6(6):CD002922. doi: 10.1002/14651858.CD002922.pub4.

ReferenceCitation: Wofsy D, Hillson JL, Diamond B. Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions. Arthritis Rheum. 2012 Nov;64(11):3660-5. doi: 10.1002/art.34624.

ReferenceCitation: Dall'Era M, Cisternas MG, Smilek DE, Straub L, Houssiau FA, Cervera R, Rovin BH, Mackay M. Predictors of long-term renal outcome in lupus nephritis trials: lessons learned from the Euro-Lupus Nephritis cohort. Arthritis Rheumatol. 2015 May;67(5):1305-13. doi: 10.1002/art.39026.

ReferenceCitation: Costedoat-Chalumeau N, Houssiau F, Izmirly P, Le Guern V, Navarra S, Jolly M, Ruiz-Irastorza G, Baron G, Hachulla E, Agmon-Levin N, Shoenfeld Y, Dall'Ara F, Buyon J, Deligny C, Cervera R, Lazaro E, Bezanahary H, Leroux G, Morel N, Viallard JF, Pineau C, Galicier L, Van Vollenhoven R, Tincani A, Nguyen H, Gondran G, Zahr N, Pouchot J, Piette JC, Petri M, Isenberg D. A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE: Assessment by Drug Levels and Self-Administered Questionnaires. Clin Pharmacol Ther. 2018 Jun;103(6):1074-1082. doi: 10.1002/cpt.885. Epub 2017 Nov 9.

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

publisher_dissemination: Wiley

ReferenceCitation: Costedoat-Chalumeau N, Galicier L, Aumaitre O, Frances C, Le Guern V, Liote F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin du LT, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacre K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Tanguy ML, Hulot JS, Lechat P, Musset L, Amoura Z, Piette JC; Group PLUS. Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study). Ann Rheum Dis. 2013 Nov;72(11):1786-92. doi: 10.1136/annrheumdis-2012-202322. Epub 2012 Nov 10.

ReferenceCitation: Costedoat-Chalumeau N, Amoura Z, Hulot JS, Aymard G, Leroux G, Marra D, Lechat P, Piette JC. Very low blood hydroxychloroquine concentration as an objective marker of poor adherence to treatment of systemic lupus erythematosus. Ann Rheum Dis. 2007 Jun;66(6):821-4. doi: 10.1136/ard.2006.067835. Epub 2007 Feb 26.

ReferenceCitation: Costedoat-Chalumeau N, Pouchot J, Guettrot-Imbert G, Le Guern V, Leroux G, Marra D, Morel N, Piette JC. Adherence to treatment in systemic lupus erythematosus patients. Best Pract Res Clin Rheumatol. 2013 Jun;27(3):329-40. doi: 10.1016/j.berh.2013.07.001.

ReferenceCitation: Jolly M, Galicier L, Aumaitre O, Frances C, Le Guern V, Liote F, Smail A, Limal N, Perard L, Desmurs-Clavel H, Boutin DL, Asli B, Kahn JE, Pourrat J, Sailler L, Ackermann F, Papo T, Sacre K, Fain O, Stirnemann J, Cacoub P, Jallouli M, Leroux G, Cohen-Bittan J, Hulot JS, Arora S, Amoura Z, Piette JC, Costedoat-Chalumeau N; PLUS group. Quality of life in systemic lupus erythematosus: description in a cohort of French patients and association with blood hydroxychloroquine levels. Lupus. 2016 Jun;25(7):735-40. doi: 10.1177/0961203315627200. Epub 2016 Feb 13.

ReferenceCitation: Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Springer-Nature

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Roche Pharma AG

location_facility: Internal medicine, Cochin hospital, APHP

title: Induction Therapy for Lupus Nephritis With no Added Oral Steroids: An Open Label Randomised Multicentre Controlled Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF

source: euctr

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: RITUXILUP

titre: Traitement d'induction des néphropathies lupiques sévères sans adjonction de corticoïdes oraux (CT) : étude randomisée ouverte multicentrique comparant un traitement classique par corticoïdes et mycophenolate mofetil (MMF) versus un traitement par Rituximab et MMF

discipline_principale: médecine interne

nom_porteur: Costedoat

prenom_porteur: Nathalie


title: Chemotherapy Induced Peripheral Neuropathy (CIPN) in Lymphoma : Longitudinal Follow up and Prognostic Factors.

acronym: NeuroTox-L

summary: Vincristine-induced peripheral neuropathy, which is commonly a sensorimotor neuropathy, remains a major complication of lymphoma patients treated with R-CHOP. The investigators propose a clinical, electrophysiological and biological follow up of patients treated by vincristine for lymphoma to determine the factors implied in VIPN occurrence.

primary_purpose: Diagnostic

ReferenceCitation: Argyriou AA, Bruna J, Marmiroli P, Cavaletti G. Chemotherapy-induced peripheral neurotoxicity (CIPN): an update. Crit Rev Oncol Hematol. 2012 Apr;82(1):51-77. doi: 10.1016/j.critrevonc.2011.04.012. Epub 2011 Sep 10.

ReferenceCitation: Caccia MR, Comotti B, Ubiali E, Lucchetti A. Vincristine polyneuropathy in man. A clinical and electrophysiological study. J Neurol. 1977 Aug 18;216(1):21-6. doi: 10.1007/BF00312811.

ReferenceCitation: Casey EB, Fullerton PM, Jelliffe AW. Vincristine neurotoxicity: a clinical and electrophysiological study of eighteen patients. Clin Sci. 1970 Apr;38(4):23P-24P. doi: 10.1042/cs038023pb. No abstract available.

ReferenceCitation: Casey EB, Jellife AM, Le Quesne PM, Millett YL. Vincristine neuropathy. Clinical and electrophysiological observations. Brain. 1973;96(1):69-86. doi: 10.1093/brain/96.1.69. No abstract available.

lead_sponsor: Centre Hospitalier Régional d'Orléans

intervention_type: Other


title: Dual Therapy Combining Raltegravir With Etravirine Maintains a High Level of Viral Suppression Over 96 Weeks in Long-term Experienced HIV-infected Individuals Over 45 Years on a PI-based Regimen: Results From the Phase II ANRS 163 ETRAL Study

summary: This multicenter, international, non randomized (single arm), open, phase II trial aims to evaluate the capacity of the dual combination raltegravir/etravirine to maintain virological success in virologically suppressed HIV-1 infected patients, of at least 45 years of age, switching from a boosted PI-containing regimen. Patients will be followed for 96 weeks. The primary endpoint was the proportion of participants with virological success at 48 weeks. Virological success is defined as the absence of 2 consecutive plasma viral load >50 copies/mL within 2 to 4 weeks apart. The study was designed to show an efficacy >90%, assuming a success rate >95%, with a power of 80% and a 5%type-1 error. A total of 160 individuals was required to achieve the objective. The principal secondary endpoint is the proportion of patients in therapeutic success up to week 48 and 96.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Merck Sharp & Dohme LLC
Janssen-Cilag Ltd.

location_country: Spain France

location_facility:
Hôpital Avicenne
Hôpital Européen Georges Pompidou
Hospital de la santa Creu i San Pau
Hôpital Jean Verdier
Hôpital Necker
Hôpital Gui de Chauliac
Hôpital Saint André
Hôpital Bicêtre
Hôpital Croix Rousse
Hôpital Sainte marguerite
Hôpital Cochin
Hospital Clinic
Hôpital de l'Archet
Hôpital Saint Louis
Hôpital Pitié-Salpétrière
CHU Hôtel Dieu
Hôpital Bichat Claude Bernard
Hospital de Bellvitge
Hôpital Bretonneau

status_simplified: Completed


title: Implantation Sur Cinq Centres Médico-Psychologiques Franciliens du Parcours Socio-Sanitaire orienté Vers le Rétablissement (PASSVers2)

summary: Prospective longitudinal uncontrolled multicenter study, with cohort follow-up, focusing on patients, professionals, relatives and structures evolution during the implementation of recovery based intervention.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Supportive Care

ReferenceCitation: Bazin, N. Les suivis sociosanitaires des personnes présentant un trouble mental sévère et persistant : expérimentation PASSVers à Versailles. Inf. Psychiatr. 95, 509-513 (2019).

lead_sponsor: Versailles Hospital

collaborators: UNION NATIONALE DE FAMILLES ET AMIS DE PERSONNES MALADES ET/OU HANDICAPÉES PSYCHIQUES

location_facility: Etablissement de Santé Mentale de Rueil-Malmaison, Groupe MGEN, secteur 92G13, CMP de Rueil-Malmaison

location_facility: Centre Hospitalier de Plaisir, secteur 78G16, CMP de Rambouillet

location_facility: Centre Hospitalier d'Argenteuil, secteurs 95G05, 95G06, 95G13,

location_facility: Centre Hospitalier de Versailles, secteur 78G17, Centre Bleuler, Versailles

location_facility: Hôpital Sainte Anne - GHU Paris Psychiatrie & Neurosciences, secteur G75015

intervention_type: Behavioral


title: Double Randomization of a Monitoring Adjusted Antiplatelet Treatment Versus a Common Antiplatelet Treatment for DES Implantation, and a Interruption Versus Continuation of Double Antiplatelet Therapy, One Year After Stenting

acronym: ARCTIC

summary: Our first hypothesis is that dose adjustment of aspirin and clopidogrel based on biological monitoring reduces the rate of severe cardiovascular complications compared to a conventional strategy in patients scheduled for drug eluting stent implantation and followed up for one year. Our second hypothesis is that interruption of clopidogrel / Prasugrel after one year of a combined therapy of clopidogrel/Prasugrel and aspirin is associated with a higher rate of severe cardiovascular complications as compared with patients in whom aspirin and clopidogrel / Prasugrel is maintained during the subsequent 6 months of follow-up.

ReferenceType: result

ReferenceCitation: Collet JP, Cuisset T, Range G, Cayla G, Elhadad S, Pouillot C, Henry P, Motreff P, Carrie D, Boueri Z, Belle L, Van Belle E, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthelemy O, Beygui F, Silvain J, Vicaut E, Montalescot G; ARCTIC Investigators. Bedside monitoring to adjust antiplatelet therapy for coronary stenting. N Engl J Med. 2012 Nov 29;367(22):2100-9. doi: 10.1056/NEJMoa1209979. Epub 2012 Nov 4.

ReferenceCitation: Collet JP, Cayla G, Cuisset T, Elhadad S, Range G, Vicaut E, Montalescot G. Randomized comparison of platelet function monitoring to adjust antiplatelet therapy versus standard of care: rationale and design of the assessment with a double randomization of (1) a fixed dose versus a monitoring-guided dose of aspirin and clopidogrel after DES implantation, and (2) treatment interruption versus continuation, 1 year after stenting (ARCTIC) study. Am Heart J. 2011 Jan;161(1):5-12.e5. doi: 10.1016/j.ahj.2010.09.029.

ReferenceCitation: Lattuca B, Silvain J, Yan Y, Pouillot C, Cuisset T, Cayla G, Henry P, Diallo A, Elhadad S, Range G, Lhermusier T, Boueri Z, Motreff P, Carrie D, Vicaut E, Montalescot G, Collet JP. Reasons for the Failure of Platelet Function Testing to Adjust Antiplatelet Therapy: Pharmacodynamic Insights From the ARCTIC Study. Circ Cardiovasc Interv. 2019 Nov;12(11):e007749. doi: 10.1161/CIRCINTERVENTIONS.118.007749. Epub 2019 Nov 7.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Collet JP, Hulot JS, Cuisset T, Range G, Cayla G, Van Belle E, Elhadad S, Rousseau H, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Barthelemy O, Beygui F, Silvain J, Vicaut E, Montalescot G; ARCTIC investigators. Genetic and platelet function testing of antiplatelet therapy for percutaneous coronary intervention: the ARCTIC-GENE study. Eur J Clin Pharmacol. 2015 Nov;71(11):1315-24. doi: 10.1007/s00228-015-1917-9. Epub 2015 Aug 13.

oa_host_type: closed

ReferenceCitation: Collet JP, Silvain J, Barthelemy O, Range G, Cayla G, Van Belle E, Cuisset T, Elhadad S, Schiele F, Lhoest N, Ohlmann P, Carrie D, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Beygui F, Vicaut E, Montalescot G; ARCTIC investigators. Dual-antiplatelet treatment beyond 1 year after drug-eluting stent implantation (ARCTIC-Interruption): a randomised trial. Lancet. 2014 Nov 1;384(9954):1577-85. doi: 10.1016/S0140-6736(14)60612-7. Epub 2014 Jul 15.

ReferenceCitation: Montalescot G, Range G, Silvain J, Bonnet JL, Boueri Z, Barthelemy O, Cayla G, Belle L, Van Belle E, Cuisset T, Elhadad S, Pouillot C, Henry P, Motreff P, Carrie D, Rousseau H, Aubry P, Monsegu J, Sabouret P, O'Connor SA, Abtan J, Kerneis M, Saint-Etienne C, Beygui F, Vicaut E, Collet JP; ARCTIC Investigators. High on-treatment platelet reactivity as a risk factor for secondary prevention after coronary stent revascularization: A landmark analysis of the ARCTIC study. Circulation. 2014 May 27;129(21):2136-43. doi: 10.1161/CIRCULATIONAHA.113.007524. Epub 2014 Apr 9.

collaborators: Allies in Cardiovascular Trials Initiatives and Organized

sponsor_collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Institut de Cardiologie- Hopital la Pitié Salpétrière


title: Early Determinants of Multidimensional Outcome at School Age After Neonatal Arterial Ischemic Stroke (AVCnn7 Years Study)

summary:
While perinatal ischemic stroke is the most frequent form of childhood stroke, early determinants of outcome remain poorly understood. Two main structural biases limit the accuracy of most studies: heterogeneity of the population and short follow-up.

Perinatal ischemic stroke includes several conditions that differ in pathophysiology and timing of occurrence. Yet, it is not surprising that risk factors and outcome depend primarily on the type of stroke. Age at evaluation also plays a major role after a neonatal insult. Even though the original lesion is static and focal in perinatal stroke, its consequences grow over time within the maturing brain and affect all fields of neurodevelopment.

The objective of the AVCnn study was to delineate the determinants, clinical and imaging presentation, mechanism, and long term outcome of a category of perinatal stroke (neonatal arterial ischemic stroke: NAIS). This led to the AVCnn cohort, which now gives us the opportunity to regularly monitor a large cohort of children having suffered an NAIS.

ReferenceCitation: Thebault G, Martin S, Brouillet D, Brunel L, Dinomais M, Presles E, Fluss J, Chabrier S; AVCnn Study Group. Manual dexterity, but not cerebral palsy, predicts cognitive functioning after neonatal stroke. Dev Med Child Neurol. 2018 Oct;60(10):1045-1051. doi: 10.1111/dmcn.13752. Epub 2018 Apr 6.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

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

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

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

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

repositories_concat: HAL

ReferenceCitation: Dinomais M, Thebault G, Hertz-Pannier L, Gautheron V, Nguyen The Tich S, Fluss J, Chabrier S; AVCnn Study Group. Is there an excess of left-handedness after neonatal stroke? Cortex. 2017 Nov;96:161-164. doi: 10.1016/j.cortex.2017.08.007. Epub 2017 Aug 16. No abstract available.

ReferenceCitation: Groeschel S, Hertz-Pannier L, Delion M, Loustau S, Husson B, Kossorotoff M, Renaud C, Nguyen The Tich S, Chabrier S, Dinomais M; AVCnn study group. Association of transcallosal motor fibres with function of both hands after unilateral neonatal arterial ischemic stroke. Dev Med Child Neurol. 2017 Oct;59(10):1042-1048. doi: 10.1111/dmcn.13517. Epub 2017 Aug 17.

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

ReferenceCitation: Dinomais M, Hertz-Pannier L, Groeschel S, Delion M, Husson B, Kossorotoff M, Renaud C, Chabrier S, The Tich SN; AVCnn Study Group. Does Contralesional Hand Function After Neonatal Stroke Only Depend on Lesion Characteristics? Stroke. 2016 Jun;47(6):1647-50. doi: 10.1161/STROKEAHA.116.013545. Epub 2016 May 10.

ReferenceCitation: Chabrier S, Peyric E, Drutel L, Deron J, Kossorotoff M, Dinomais M, Lazaro L, Lefranc J, Thebault G, Dray G, Fluss J, Renaud C, Nguyen The Tich S; Accident Vasculaire Cerebral du nouveau-ne (AVCnn; [Neonatal Stroke]) Study Group. Multimodal Outcome at 7 Years of Age after Neonatal Arterial Ischemic Stroke. J Pediatr. 2016 May;172:156-161.e3. doi: 10.1016/j.jpeds.2016.01.069. Epub 2016 Mar 9.

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

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

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Ministry for Health and Solidarity, France

location_facility:
Chu de Saint Etienne
Chu D'Angers
Centre Hospitalier de La Cote Basque
Hopital Necker
Chu de Brest


title: Evaluation of Daily HemoDialysis at Low Dialysate Flow in Patients Previously Treated With Conventional Hemodialysis

summary: HDQ 200 is an interventional multicenter study. This is a before-and-after design in which the patient is his own control. The main objective of the study is to determine the percentage of success of a procedure of daily hemodialysis at low dialysate flow. All patients treated with conventional hemodialysis, for at least 3 months and clinically stable, can be included in the study. Their 3 months data prior to inclusion is collected retrospectively. These 3 months of conventional hemodialysis are the reference period. Patients are then treated with daily hemodialysis at low dialysate flow for 3 months. During this 3 months period, the same data as during the period of conventional hemodialysis are collected prospectively.

status: Terminated

lead_sponsor: Association Pour L'utilisation Rein Artificiel Région Lyonnaise

collaborators: Association Nationale pour la promotion de la Dialyse Quotidienne (ANDIQ, France)

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

location_facility: Hospices Civils de Lyon - Hôpital Edouard Herriot

status_simplified: Unknown


title: SEMI-CLOSED LOOP "FOR THE CONTROL OF BLOOD GLUCOSE IN DIABETIC SUBJECTS DIABELOOP First CLINICAL PROJECT: Under Project 3 (UP3), CREATING A DATABASE

summary: The aim this study is the acquisition and management of a data base for the development of the glycaemic regulation algorithms. This database will integrate the measures of blood glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of insulin delivered by Debiotech JewelPUMP and the level of insulin in the blood. This database will also contain the bolus of insulin injected at meals and the content of meals, the reduction insulin level during physical activity and the quantification of this physical activity. A study will also be conducted to compare the pharmacokinetics of a bolus of insulin identical with the JewelPUMP either the usual pump of the patient.

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

location_facility:
CHU de Nancy
CHU de Caen
CHU Toulouse
Chu Montpellier
University Hospital Grenoble
Centre Hospitalier Sud Francilien
CHU Jean Minjoz

intervention_type: Device


acronym: MALIBU

lead_sponsor: International Extranodal Lymphoma Study Group (IELSG)

summary:
Single-arm, phase II clinical trial of patients with Extranodal Marginal Zone Lymphoma (EMZL). It is planned to recruit 130 patients.

Additional patients with Splenic Marginal Zone Lymphoma (SMZL), up to 30, and Nodal Marginal Zone Lymphoma (NMZL), up to 15, will be included in the trial in order to preliminary explore the clinical activity and safety of the combination treatment proposed.

The study primary endpoints will be analysed on the EMZL population. Outcome of patients with SMZL and NMZL will be analysed and reported separately

location_facility: Fondazione IRCCS - Istituto Nazionale dei Tumori

location_facility: IRCCS Centro di Riferimento Oncologico di Aviano

location_facility: Ospedale di Circolo e Fondazione Macchi di Varese

location_facility: AAST Grande Ospedale Metropolitano Niguarda

location_facility: Fondazione IRCCS - Policlinico San Matteo

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti - Università Politecnica delle Marche

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)

location_facility: Università degli Studi di Roma La Sapienza

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Azienda Ospedaliera Arcispedale Santa Maria Nuova IRCCS

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterand

location_facility: Istituto Oncologico della Svizzera Italiana (IOSI)

location_facility: Giovanni Paolo II/I.R.C.C.S. Istituto Tumori

location_facility: A.O.U. Città della Salute e della Scienza di Torino Ospedale Molinette

location_facility: Fondazione IRCCS - Cà Granda - Ospedale Maggiore Policlinico

location_facility: CHU de Grenoble - Hôpital Albert MICHALLON

title: MALIBU Trial - Phase II Study of Combination Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas

location_country: Italy Portugal Switzerland Belgium France


title: Role of High Blood Pressure and Sleep Apnea in Type 2 Diabetic Macular Edema

acronym: OMHADIA

summary: Macular edema remains a major cause of vision impairment in diabetic patients. Its pathogenesis is multifactorial and incompletely understood. Systemic factors seam to play a role in this pathogenesis, including high blood pressure. The objective of the study is to evaluate the effect of an intensified intervention on blood pressure and sleep apnea with that of conventional treatment in patients with type 2 diabetes and diabetic macular edema.

ReferenceCitation: Paques M, Massin P, Sahel JA, Gaudric A, Bergmann JF, Azancot S, Levy BI, Vicaut E. Circadian fluctuations of macular edema in patients with morning vision blurring: correlation with arterial pressure and effect of light deprivation. Invest Ophthalmol Vis Sci. 2005 Dec;46(12):4707-11. doi: 10.1167/iovs.05-0638.

location_facility: Service d'Ophtalmologie, Hôpital Avicenne

location_facility: Service d'ophtalmologie, Hôpital de la Vision, La Timone

location_facility: Hôpital Lariboisière, service d'Ophtalmologie

location_facility: Service d'Ophtalmologie IV, Hôpital des XV-XX


title: An Open Prospective Randomised Long-Term Effectiveness Study, Comparing Best Medical Practice With or Without Adjunctive VNS Therapy in Patients 16 Years and Older With Pharmaco-resistant Partial Epilepsy

summary: This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.

ReferenceCitation: Gilliam F. Optimizing health outcomes in active epilepsy. Neurology. 2002 Apr 23;58(8 Suppl 5):S9-20. doi: 10.1212/wnl.58.8_suppl_5.s9.

ReferenceCitation: Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.

ReferenceCitation: Sillanpaa M, Jalava M, Kaleva O, Shinnar S. Long-term prognosis of seizures with onset in childhood. N Engl J Med. 1998 Jun 11;338(24):1715-22. doi: 10.1056/NEJM199806113382402.

ReferenceCitation: Mattson RH, Cramer JA, Collins JF, Smith DB, Delgado-Escueta AV, Browne TR, Williamson PD, Treiman DM, McNamara JO, McCutchen CB, et al. Comparison of carbamazepine, phenobarbital, phenytoin, and primidone in partial and secondarily generalized tonic-clonic seizures. N Engl J Med. 1985 Jul 18;313(3):145-51. doi: 10.1056/NEJM198507183130303.

ReferenceCitation: Mattson RH, Cramer JA, Collins JF. A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. The Department of Veterans Affairs Epilepsy Cooperative Study No. 264 Group. N Engl J Med. 1992 Sep 10;327(11):765-71. doi: 10.1056/NEJM199209103271104.

ReferenceCitation: Mattson RH, Cramer JA, Collins JF. Prognosis for total control of complex partial and secondarily generalized tonic clonic seizures. Department of Veterans Affairs Epilepsy Cooperative Studies No. 118 and No. 264 Group. Neurology. 1996 Jul;47(1):68-76. doi: 10.1212/wnl.47.1.68.

ReferenceCitation: Schmidt D. The clinical impact of new antiepileptic drugs after a decade of use in epilepsy. Epilepsy Res. 2002 Jun;50(1-2):21-32. doi: 10.1016/s0920-1211(02)00065-7.

ReferenceCitation: Lhatoo SD, Wong IC, Polizzi G, Sander JW. Long-term retention rates of lamotrigine, gabapentin, and topiramate in chronic epilepsy. Epilepsia. 2000 Dec;41(12):1592-6. doi: 10.1111/j.1499-1654.2000.001592.x.

ReferenceCitation: Morris GL 3rd, Mueller WM. Long-term treatment with vagus nerve stimulation in patients with refractory epilepsy. The Vagus Nerve Stimulation Study Group E01-E05. Neurology. 1999 Nov 10;53(8):1731-5. doi: 10.1212/wnl.53.8.1731. Erratum In: Neurology 2000 Apr 25;54(8):1712.

ReferenceCitation: Malow BA, Edwards J, Marzec M, Sagher O, Ross D, Fromes G. Vagus nerve stimulation reduces daytime sleepiness in epilepsy patients. Neurology. 2001 Sep 11;57(5):879-84. doi: 10.1212/wnl.57.5.879.

ReferenceCitation: Harden CL, Pulver MC, Ravdin LD, Nikolov B, Halper JP, Labar DR. A Pilot Study of Mood in Epilepsy Patients Treated with Vagus Nerve Stimulation. Epilepsy Behav. 2000 Apr;1(2):93-99. doi: 10.1006/ebeh.2000.0046.

ReferenceCitation: Elger G, Hoppe C, Falkai P, Rush AJ, Elger CE. Vagus nerve stimulation is associated with mood improvements in epilepsy patients. Epilepsy Res. 2000 Dec;42(2-3):203-10. doi: 10.1016/s0920-1211(00)00181-9.

ReferenceCitation: Clark KB, Naritoku DK, Smith DC, Browning RA, Jensen RA. Enhanced recognition memory following vagus nerve stimulation in human subjects. Nat Neurosci. 1999 Jan;2(1):94-8. doi: 10.1038/4600.

ReferenceCitation: McLachlan RS, Sadler M, Pillay N, Guberman A, Jones M, Wiebe S, Schneiderman J. Quality of life after vagus nerve stimulation for intractable epilepsy: is seizure control the only contributing factor? Eur Neurol. 2003;50(1):16-9. doi: 10.1159/000070853.

ReferenceCitation: Cramer JA, Ben Menachem E, French J. Review of treatment options for refractory epilepsy: new medications and vagal nerve stimulation. Epilepsy Res. 2001 Nov;47(1-2):17-25. doi: 10.1016/s0920-1211(01)00286-8.

ReferenceCitation: Gilliam FG, Fessler AJ, Baker G, Vahle V, Carter J, Attarian H. Systematic screening allows reduction of adverse antiepileptic drug effects: a randomized trial. Neurology. 2004 Jan 13;62(1):23-7. doi: 10.1212/wnl.62.1.23.

ReferenceCitation: Ryvlin P, Gilliam FG, Nguyen DK, Colicchio G, Iudice A, Tinuper P, Zamponi N, Aguglia U, Wagner L, Minotti L, Stefan H, Boon P, Sadler M, Benna P, Raman P, Perucca E. The long-term effect of vagus nerve stimulation on quality of life in patients with pharmacoresistant focal epilepsy: the PuLsE (Open Prospective Randomized Long-term Effectiveness) trial. Epilepsia. 2014 Jun;55(6):893-900. doi: 10.1111/epi.12611. Epub 2014 Apr 22. Erratum In: Epilepsia. 2014 Sep;55(9):1476. Epilepsia. 2015 Jun;56(6):983.

oa_colors: green hybrid

evidence: open (via crossref license)

unpaywall_oa_status: hybrid

lead_sponsor: Cyberonics, Inc.

location_country:
Germany
Italy
Norway
United Kingdom
Sweden
Netherlands
Belgium
Spain
Canada
France

location_facility: Hopital Roger Salengro, Service de Neurologie

location_facility: Sächsisches Epilepsiezentrum Radeberg, Epilepsiezentrum Kleinwachau

location_facility: Universita degli Studi di Cagliari - Policlinico Monserrato, Clinica Neurologica

location_facility: Azienda Ospendaliero-Universitaria, Caressi Dep Neuroscience

location_facility: Hospital General de Valencia, Neurology/Neurophisiology

location_facility: Hôpital Neurologique, Untité d'épileptologie

location_facility: Hospital Clínico Universitario, Servicio de neurología

location_facility: Addenbrookes Hospital, Dept of Neurosurgery

location_facility: Montreal Neurological Institute, Clinical Research

location_facility: Klinik der Ernst-Moritz-Arndt-Universität, Neurologische Klinik

location_facility: Universitätsklinik Erlangen, Zentrum für Epilepsie ZEE

location_facility: Universitetssjukhuset i Lund, Neurologiska kliniken

location_facility: Hôpital Gui De Chauliac, Service Explorations Neurologiques et Epileptologie

location_facility: ULB-Hôpital Erasme, Centre de référence pour le traitement de l'épilepsie réfractaire - Neurologie

location_facility: Azienda Ospedaliera "Bianchi Melacrino Morelli", Centro Regionale Epilessie

location_facility: Hôpital Sainte-Anne, Service de Neurochirurgie

location_facility: Medisch Spectrum Twente, Dienst Neurologie

location_facility: Walton Centre, Dept of Neurosciences, Clinical Sciences Centre

location_facility: Azienda Ospedaliero Universitaria - Ospedali Riuniti Umberto I - Lancisi - Salesi, NeuroPsichiatria Infantile

location_facility: Kings College Hospital, Dept of Neurosurgery

location_facility: UZ Gent, Department of Neurology, 1K12/A

location_facility: National Hospital for Neurology and Neurosurgery

location_facility: Spesialsykehuset for Epilepsi, Dep of Neurodiagnostics

location_facility: Institute of Neuroscience and Physiology, Clinical Neuroscience and Rehabilitation

location_facility: Stichting Epilepsie Instituut Nederland, Dienst Neurologie

location_facility: Medisch Centrum Rijnmond-Zuid, locatie Clara, Dienst Neurologie

location_facility: Foothills Hospital, Neurology Department

location_facility: Hospital Ruber Internacional, Servicio de neurología

location_facility: Università Cattolica Del Sacro Cuore, Istituto di NeuroChirurgia

location_facility: Hospital General Basico De La Defensa de Valencia, Servicio de neurología

location_facility: Centro Epilessia, Dipartimento di Neuroscienze

location_facility: Klinikum der Philips-Universität Marburg, Fachbereich, 20 - Medizin / Klinik Neurologie / Epilepsie Zentrum

location_facility: Universita di Bologna, Clinica Neurologica

location_facility: Universitätskliniken Bonn, Klinik für Epileptologie


title: A Randomized Double-blind Phase II Study Evaluating the Role of Maintenance Therapy With Cabozantinib in High Grade Uterine Sarcoma (HGUtS) After Stabilization or Response to Doxorubicin +/- Ifosfamide Following Surgery or in Metastatic First Line Treatment

summary:
This study aims to investigate a drug called Cabozantinib which belongs to a family of drugs that have effects on tumour growth, blood supply, invasion and spread.

Therefore, we want to find out whether taking cabozantinib after treatment with surgery and chemotherapy is effective and safe for patients who responded or had stable disease after their chemotherapy.

All participants will receive 4-6 cycles of standard chemotherapy. Those with stabilization or response to the standard chemotherapy will be split into 2 groups (cabozantinib or placebo).

ReferenceCitation: Hanvic B, Ray-Coquard I. Gynecological sarcomas: literature review of 2020. Curr Opin Oncol. 2021 Jul 1;33(4):345-350. doi: 10.1097/CCO.0000000000000753.

ReferenceCitation: Ray-Coquard I, Hatcher H, Bompas E, Casado A, Westermann A, Isambert N, Casali PG, Pratap S, Stark D, Valverde C, Anand A, Huizing M, Floquet A, Lindner L, Hermes B, Seddon B, Coens C, Jones R, Reed N. A randomized double-blind phase II study evaluating the role of maintenance therapy with cabozantinib in high-grade uterine sarcoma after stabilization or response to doxorubicin +/- ifosfamide following surgery or in metastatic first line treatment (EORTC62113). Int J Gynecol Cancer. 2020 Oct;30(10):1633-1637. doi: 10.1136/ijgc-2020-001519. Epub 2020 Jun 15.

license: cc-by-nc

license_normalized: cc-by-nc

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

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

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

publisher_dissemination: British Medical Journal

collaborators:
Gynecologic Oncology Group
NHS Greater Glasgow and Clyde

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

location_country:
Italy
United Kingdom
Netherlands
Spain
France

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Cambridge University Hospital NHS - Addenbrookes Hospital

location_facility: Academisch Medisch Centrum at University of Amsterdam


acronym: FINESSE

lead_sponsor: Institut de Recherches Internationales Servier

summary: The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.

ReferenceCitation: Liao M, Zhou J, Wride K, Lepley D, Cameron T, Sale M, Xiao J. Population Pharmacokinetic Modeling of Lucitanib in Patients with Advanced Cancer. Eur J Drug Metab Pharmacokinet. 2022 Sep;47(5):711-723. doi: 10.1007/s13318-022-00773-w. Epub 2022 Jul 18.

location_facility: Orszagos Onkologiai Intezet Kemoterapia B es Klin.Farm.Oszt.

location_facility: Kliniken Essen-Mitte Klinik für Senologie - Brustzentrum

location_facility: UZ Leuven Campus Gasthuisberg Dept. of General Medical

location_facility: MD Anderson Cancer Center Unidad de Investigación Clínica

location_facility: Institut Claudius Regaud Dpt d'Oncologie Médicale

location_facility: H. Clínico de Valencia Servicio de Hematología y oncología Médica

location_facility: McGill University Department of Oncologie - Clinical Reserach Program

location_facility: H. Ramón y Cajal Servicio de Oncología Médica

location_facility: KLINIKUM OFFENBACH Klinik für Gynäkologie und Geburtshilfe

location_facility: Cliniques Universitaires St. Luc Oncology - Breast Clinic

location_facility: Istituto Europeo di Oncologia Divisione Sviluppo Nuovi Farmaci per Terapie Innovative

location_facility: Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet

location_facility: Western General Hospital Edinburgh Cancer Centre

location_facility: Institut Gustave Roussy Dépt d'oncologie - Cancer du sein

location_facility: The Royal Marsden NHS Trust Dpt of Medicine-Oncology

location_facility: H. Valle de Hebrón Servicio de Oncología

location_facility: University Health Network - Princess Margaret Hospital

location_facility: Grand Hôpital de Charleroi Oncologie-Hématologie

location_facility: Clinique Sainte-Elisabeth Médecine Interne - Oncologie

location_facility: Nottingham University Hospitals NHS Trust Department of Clinical Oncology

title: An Open, 3-cohort, Phase II Trial Testing Oral Administration of Lucitanib in Patients With FGFR1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

location_country:
Germany
Italy
Hungary
United Kingdom
Australia
Belgium
Spain
Canada
France

ipd_sharing: Yes


title: Study of Socio-demographic Factors, Behaviors and Practices Associated With Infection With SARS-CoV-2

acronym: ComCor

summary:
The objective of the study is to identify socio-demographic factors, behaviors and practices associated with infection with SARS-CoV-2 to help determine where and how patients mostly get infected with SARS-CoV-2.

It is a case-control study including :

cases identified by the nationwide system of positive SARS-CoV-2 tests (COVID-19 diagnosis information system, SIDEP) (currently limited to qRT-PCR) and invited to participate by the National Health Insurance (CNAM) which hosts the data from the nationwide test system;
controls included via Ipsos, a polling institute with access to personal data from a panel from which they will include controls matched on age (divided into 10-year categories), gender and geographic area (departement);
cases will be offered to invite a person they live with to participate in the study offering another case-control analysis inside a household. These participants will be required to report the result of the test as recommended by contact tracing guidelines to determine whether they are cases or controls.

Data will be collected via a self-administered online questionnaire. Some of the participants will be called for a complementary telephone questionnaire to measure reliability of online retrieved data and explore more specific aspects of SARS-CoV-2 transmission.

lead_sponsor: Institut Pasteur

collaborators: Institut de Recherche en Santé Publique, France

location_facility:
Caisse Nationale d'Assurance Maladie
IPSOS


title: A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel-group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)

acronym: BouNDless

summary:
This is a multi-center, randomized, double-blind, double-dummy, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR-LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR-LD/CD.

Subjects can continue to an optional open-label extension period.

lead_sponsor: NeuroDerm Ltd.

location_country:
Italy
Poland
Portugal
Slovakia
Hungary
Israel
United Kingdom
Netherlands
Austria
Belgium
United States
Spain
Czechia
Ukraine
Russian Federation
France

location_facility: Hospital Universitari General de Catalunya

location_facility: NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki

location_facility: Mount Sinai Medical center Movement Disorders Center

location_facility: Hartford Healthcare Chase Family Movement Disorders Center

location_facility: Policlinico Tor Vergata - UOSD Parkinson

location_facility: USF Parkinson's Disease and Movement Disorders Center

location_facility: Vinnytsia O.I. Yushchenko Regional Psychoneurology Hospital

location_facility: Hospital Universitario Virgen del Rocío, Laboratorio 104.

location_facility: Hospital Universitario central de Asturias

location_facility: Institute of Gerontolgoy - Parkinsons disease Treatment Centre

location_facility: Krakowska Akademia Neurologii Sp. z o. o

location_facility: Cedar- Sinai Medical Center Department of Neurology

location_facility: Ukrainian Medical Stomatological Academy based on Poltava Regional Clinical Hospital n.a. M.V.Skliphosovskyy

location_facility: University of Florida Norman Fixel Institute for Neurological Diseases

location_facility: Rutgers-Robert Wood Johnson Medical School

location_facility: Centro Ricerca Parkinson San Raffaele Cassino

location_facility: University of Arkansas for Medical Sciences

location_facility: Univerzitna nemocnica L. Pasteura Kosice

location_facility: Rocky Mountain Movement Disorders Center

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: The first Saint-Petersburg State Medical University named after IP Pavlov

location_facility: Hospital Universitari de la Vall d'Hebron

location_facility: Ospedale di Grosseto, Azienda USL Toscana Sud Est

location_facility: Parkinsons Disease and Movement Disorders Center of Boca Raton

location_facility: AOU University of Campania "Luigi Vanvitelli"

location_facility: University Chieti CeSI MET Clinical research center-CRC

location_facility: University of Kentucky, Neurology and Movement Disorder

location_facility: Corporal Michael J. Crescenz VA Medical Center

location_facility: Municipal Non-commercial Institution '' City hospital #9" of Zaporizhzhya City Council

location_facility: Novosibirsk regional specialized scientific-practical neurological center on the basis City Clinical Hospital 34

location_facility: Directorate of Medicine & Integrated Care, Imperial College Healthcare NHS Trust

location_facility: Hospital General Universitario de Elche, Edificio principal

location_facility: Hospital Universitario y Politcnico de La Fe

location_facility: Neurologicka klinika Fakutni nemocnice sv. Anny v Brne

location_facility: Oddział Neurologii ul. L. Kondratowicza 8

location_facility: Federal Siberian Scientic Clinical Center of FMBA


acronym: PREMIER

lead_sponsor: Pharnext S.C.A.

summary:
The study will consist of 2 periods: Double-blind Treatment and Open-Label Extension(OLE) Period.

-Double-blind Treatment Period - This will be randomized, double-blind, placebo-controlled part of the study which will be conducted in parallel groups, ie,1 group receiving the active treatment (PXT3003) and the other group receiving placebo.

Primary endpoint of the study will be assessed at Month 15.

-Open-label Extension (OLE) Period - All subjects completing Double-blind Treatment Period will be given an opportunity to enter the OLE Period of the study and receive the active treatment (PXT3003). The duration of the OLE Period will be based on Sponsor discretion, ie, Sponsor intends to keep the study open until the study drug PXT3003 is commercially available.

During this period, the long-term safety and efficacy of PXT3003 will be assessed as an exploratory objective.

Double-blind Treatment Period Objectives:

Primary:

To evaluate the efficacy of treatment with PXT3003 (a fixed-dose combination of [RS]-baclofen, naltrexone hydrochloride [HCl], and D-sorbitol) compared to placebo in subjects with Charcot-Marie-Tooth disease type 1A (CMT1A).

Secondary:

To evaluate the safety and tolerability of PXT3003 treatment in subjects with CMT1A.

Exploratory:

To characterize the relationship between plasma biomarkers and response to PXT3003 treatment.

OLE Period Objective:

Exploratory:

To evaluate the long-term safety and efficacy of PXT3003.

sponsor_collaborators:
Pharnext S.C.A.
Worldwide Clinical Trials

location_facility: Centre de reference des maladies neuromusculaires AOC Hopital Pellegrin CHU de Bordeaux

location_facility: University of Florida Clinical Research Center

location_facility: CHU de Quebec-Universite Laval- Hopital Enfant-Jesus

location_facility: University Hospital Muenster UKM Department of Neurology

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Massachusetts General Hospital Neuromuscular Diagnostic Center

location_facility: University of Kansas Medical Center Research Institute

location_facility: University Hospital RWTH Aachen, Department of Neurology and Institute for Neuropathology

location_facility: Neurology Clinic at University of Washington Medical Center

location_facility: Friedrich-Baur-Institut, Neurologische Klinik und Poliklinik Ludwig-Maximilians-Universität

location_facility: University of Miami Leonard M. Miller School of Medicine

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Centre de Reference des Maladies Neuromusculaires AOC Service de Neurologie, CHU d'Angers

location_facility: The Ohio State University Wexner Medical Center

location_facility: Hadassah Ein Kerem University Medical Center Department of Neurology

location_facility: Rigshospitalet, University of Copenhagen Copenhagen Neuromuscular Center

location_facility: Hospital Universitario y Politécnico La Fé

location_facility: University Hospital GB Rossi UOC Neurologia B, AOUI Verona Department of Neuroscience, Biomedicine and Movement Sciences

location_facility: UCLA Department of Psychiatry and Biobehavioral Sciences

location_facility: Service de Neurologie et Maladies Neuromusculaires, CHU de Marseille - Hopital La Timone

location_facility: MU Health Care Neurology and Sleep Disorders Clinic

location_facility: Universitätsklinikum Tübingen Crona Kliniken Neuromuskuläres Zentrum

location_facility: UC Davis Health Department of Physical Medicine and Rehabilitation

location_facility: UNC Department of Neurology Peripheral Neuropathy Center

location_facility: National Neuromuscular Research Institute

location_facility: Azienda Ospedaliera Universitaria Policlinico "G. Martino" di Messina

location_facility: UHN Toronto General Hospital Krembil Neuroscience Centre

location_facility: Colombia University Department of Neurology

location_facility: Association lnstitut de Myologie Hopital Pitie-Salpetriere Service de Neuro-Myologie

location_facility: Ottawa Hospital Research Institute- Neuromuscular Research Centre

location_facility: Montreal Neurological Institute and Hospital-Clinical Research Unit

location_facility: Providence St. Luke's Rehabilitation Medical Center

location_facility: CIUSS de Saguenay-Lac-Saint-Jean Centre d'etudes Cliniques

location_facility: University Medical Centre Goettingen, Dept. of Clinical Neurology

location_facility: Hackensack Meridian Health Hackensack University Medical Center

location_facility: Advent Health Medical Group Neurology Orlando

location_facility: Centre d'investigation Clinique CHU de Strasbourg Hopital de Hautepierre

location_facility: Azienda Ospedaliera Universitaria San Martino Universita Degli Studi di Genova Clinica Neurologica

title: A Multi-center, Randomized, Double-blind, Placebo Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth Type 1A (CMT1A)

location_country:
Germany
Italy
Israel
Denmark
Belgium
United States
Spain
Canada
France


title: A Phase Ib Study of Oral Selinexor in Adult Patients With Relapsed/Refractory B-cell Lymphoma Receiving R-DHAOx or R-GDP

acronym: SELINDA

summary:
This is an open label, multicenter, dose escalation, phase Ib study to determine the recommended phase II dose (RP2D), by assessing the maximum tolerated dose (MTD), safety and preliminary efficacy of selinexor in adult patients with relapsed/refractory B-cell malignancies receiving either R-DHAOx (Group A) or R-GDP (Group B). This dose escalation phase will be followed by an exploratory expansion phase in the same population with 12 patients enrolled in each group, who will receive selinexor at the RP2D.

The "3+3" design will be applied for dose escalation. The escalation will be performed independently in two distinct groups:

Group A : Oral selinexor + R-DHAOx for 3 cycles (3-week cycles)
Group B: Oral selinexor + R-GDP for 3 cycles (3-week cycles)

The choice of the conventional immunotherapy regimen which will be administered to each patient, R-DHAOx (Group A) or R-GDP (Group B), is left at the investigator's decision before patient's inclusion. Different dose levels for selinexor administration will be examined sequentially in each group by the Dose Escalation Committee (DEC): 4 doses of selinexor per 3-week cycle at 20 mg flat (Dose Level -1, DL-1), 40 mg flat (DL1), 60 mg flat (DL2) or 80 mg flat (DL3) will be taken orally by the patient on D1, D3, D8 and D10 of each cycle (dosing weeks = week 1 and week 2 of each 3-week cycle). Dose escalation will begin at DL1 and will continue until the MTD is exceeded or until the highest dose level defined in the study (DL3) is reached.

Dose escalation to the next planned dose level will be decided by the DEC based on the number of DLTs observed during the DLT assessment period.

The dose escalation phase will be followed by an exploratory expansion phase in the same two groups (Groups A and B), depending on the decision of the Independent Data Monitoring Committee (IDMC) after review of safety data at the end of dose escalation part.

Patients enrolled in the expansion phase will receive selinexor at the RP2D defined by the IDMC, together with either of the conventional regimen R-DHAOx or R-GDP (left at the investigator's choice).

lead_sponsor: The Lymphoma Academic Research Organisation

location_facility:
Hôpital Saint-Louis
Institut Jules Bordet
CHU Dijon
Centre Henri Becquerel
CHRU de Lille - Hôpital Claude Huriez
CHU Nancy - Hôpital de Brabois
CHU Montpellier - Hôpital Saint Eloi
CHU Bordeaux - Centre François Magendie


title: Phase II Open-label, Multicentre, Randomized Trial of Neoadjuvant Palbociclib in Combination With Hormonal Therapy and HER2 Blockade Versus Paclitaxel in Combination With HER2 Blockade for Postmenopausal Patients With Hormone Receptor Positive/HER2 Positive Early Breast Cancer

acronym: TOUCH

summary: This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.

ReferenceCitation: Biganzoli L, Wildiers H, Oakman C, Marotti L, Loibl S, Kunkler I, Reed M, Ciatto S, Voogd AC, Brain E, Cutuli B, Terret C, Gosney M, Aapro M, Audisio R. Management of elderly patients with breast cancer: updated recommendations of the International Society of Geriatric Oncology (SIOG) and European Society of Breast Cancer Specialists (EUSOMA). Lancet Oncol. 2012 Apr;13(4):e148-60. doi: 10.1016/S1470-2045(11)70383-7. Epub 2012 Mar 30.

ReferenceCitation: Biganzoli L, Aapro M, Loibl S, Wildiers H, Brain E. Taxanes in the treatment of breast cancer: Have we better defined their role in older patients? A position paper from a SIOG Task Force. Cancer Treat Rev. 2016 Feb;43:19-26. doi: 10.1016/j.ctrv.2015.11.009. Epub 2015 Dec 15.

ReferenceCitation: Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012 Oct 4;490(7418):61-70. doi: 10.1038/nature11412. Epub 2012 Sep 23.

ReferenceCitation: Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3. Erratum In: Lancet Oncol. 2016 Apr;17 (4):e136. Lancet Oncol. 2016 Jul;17 (7):e270.

ReferenceCitation: Demidenko E. Sample size and optimal design for logistic regression with binary interaction. Stat Med. 2008 Jan 15;27(1):36-46. doi: 10.1002/sim.2980.

ReferenceCitation: Finn RS, Dering J, Conklin D, Kalous O, Cohen DJ, Desai AJ, Ginther C, Atefi M, Chen I, Fowst C, Los G, Slamon DJ. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res. 2009;11(5):R77. doi: 10.1186/bcr2419.

ReferenceCitation: Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Dieras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936. doi: 10.1056/NEJMoa1607303.

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Herschkowitz JI, He X, Fan C, Perou CM. The functional loss of the retinoblastoma tumour suppressor is a common event in basal-like and luminal B breast carcinomas. Breast Cancer Res. 2008;10(5):R75. doi: 10.1186/bcr2142. Epub 2008 Sep 9.

ReferenceCitation: Jenkins EO, Deal AM, Anders CK, Prat A, Perou CM, Carey LA, Muss HB. Age-specific changes in intrinsic breast cancer subtypes: a focus on older women. Oncologist. 2014 Oct;19(10):1076-83. doi: 10.1634/theoncologist.2014-0184. Epub 2014 Aug 20.

ReferenceCitation: Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. doi: 10.1200/JCO.2009.23.3734. Epub 2009 Sep 28.

ReferenceCitation: Kaufman B, Mackey JR, Clemens MR, Bapsy PP, Vaid A, Wardley A, Tjulandin S, Jahn M, Lehle M, Feyereislova A, Revil C, Jones A. Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: results from the randomized phase III TAnDEM study. J Clin Oncol. 2009 Nov 20;27(33):5529-37. doi: 10.1200/JCO.2008.20.6847. Epub 2009 Sep 28.

ReferenceCitation: Malorni L, Piazza S, Ciani Y, Guarducci C, Bonechi M, Biagioni C, Hart CD, Verardo R, Di Leo A, Migliaccio I. A gene expression signature of retinoblastoma loss-of-function is a predictive biomarker of resistance to palbociclib in breast cancer cell lines and is prognostic in patients with ER positive early breast cancer. Oncotarget. 2016 Sep 13;7(42):68012-68022. doi: 10.18632/oncotarget.12010.

ReferenceCitation: Miles D, Baselga J, Amadori D, Sunpaweravong P, Semiglazov V, Knott A, Clark E, Ross G, Swain SM. Treatment of older patients with HER2-positive metastatic breast cancer with pertuzumab, trastuzumab, and docetaxel: subgroup analyses from a randomized, double-blind, placebo-controlled phase III trial (CLEOPATRA). Breast Cancer Res Treat. 2013 Nov;142(1):89-99. doi: 10.1007/s10549-013-2710-z. Epub 2013 Oct 16.

evidence: open (via page says license)

publisher_dissemination: Springer

ReferenceCitation: Witkiewicz AK, Ertel A, McFalls J, Valsecchi ME, Schwartz G, Knudsen ES. RB-pathway disruption is associated with improved response to neoadjuvant chemotherapy in breast cancer. Clin Cancer Res. 2012 Sep 15;18(18):5110-22. doi: 10.1158/1078-0432.CCR-12-0903. Epub 2012 Jul 18.

lead_sponsor: ETOP IBCSG Partners Foundation

collaborators:
Pfizer
Hoffmann-La Roche

sponsor_collaborators:
ETOP IBCSG Partners Foundation
Pfizer
Hoffmann-La Roche

location_country: Italy Switzerland Belgium France

location_facility: Università del Piemonte Orientale - SCDU Oncologia, Corso Mazzini 18

location_facility: Hospital of Prato, Via Dolce dei Mazzamuti, 7

location_facility: Ospedale S. Orsola-Malpighi, Viale Ercolani 4/2

location_facility: E.O. Ospedali Galliera, Mura delle Cappuccine, 14

location_facility: Clinique Saint- Joseph, Rue de Hesbaye 75

location_facility: ASO "SS Antonio e Biagio Cesare Arrigo, Via Venezia 16

location_facility: Ospedali Riuniti di Bergamo, A.O.Papa Giovanni XXIII, Piazza OMS1

location_facility: A.O. Universitaria Pisana Ospedale Santa Chiara Pisa, Via Roma 67

location_facility: Universitatsspital Basel, Petersgraben 4

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: AO Universitaria Ospedale Di Circolo e Fondazione,v.le L. Borri, 57

location_facility: ASST Spedali Civili Brescia, Piazzale Spedali Civili n.1

location_facility: Brustzentrum Thurgau / Kantonsspital Frauenfeld, Pfaffenholzstrasse 4

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Oncology Institute of Southern Switzerland (IOSI), Ospedale San Giovanni, IOSI

location_facility: Centro di Riferimento Oncologico (CRO), Via Franco Gallini 2

location_facility: UO Oncologia, Rimini Hospital, Via Settembrini 2

location_facility: Comprensorio Sanitario Bolzano, Via Lorenz Bohler, 5

location_facility: Azienda Ospedaliero-Universitaria di Parma, via Gramsci 14

location_facility: Ospedale Civile di Lecco,Via della Filanda 14

location_facility: Azienda Ospedaliero-Universitaria di Udine, Piazzale S.M. Misericordia 15

location_facility: Clinica Oncologica-Ospedali Riuniti Ancona, Via Conca n.71,

location_facility: University Hospital Zurich, Frauenklinikstrasse 10

location_facility: Clinique Saint Elizabeth, Place Louise Godin 15

location_facility: CHR de la Citadelle, Boulevard du XIIe de Ligne, 1

location_facility: Istituto scientifico Romagnolo per lo studio e la cura,Via Piero Maroncelli 40

location_facility: U.O Medicina Oncologica Ospedale di Carpi, Via G. Molinari, 2

location_facility: Istituti Clinici Scientifici Maugeri SpA-SB,Via Salvatore Maugeri N° 10

location_facility: Kantonsspital St. Gallen, Rorschacher Strasse 95

location_facility: Ospedale Policlinico San Martino,Largo Rosanna Benzi,10

location_facility: Santa Maria delle Croci Hospital, Viale Randi 5


title: A Single-arm Dose Finding Phase Ib Multicenter Study of the Oral Smoothened Antagonist LDE255 in Combination With Azacitidine for High Risk Myelodysplastic Syndrome Patients

summary: This study is a phase Ib add-on study of the combination of LDE255 to azacitidine in patients without marrow response after at least 6 cycles of azacitidine.

lead_sponsor: Groupe Francophone des Myelodysplasies

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Novartis

location_facility: Hôpital Saint-Louis - Service d'hématologie AJA

location_facility: Hôpital Saint Louis - Service Hématologie Sénior


title: Phase III Randomised Trial to Evaluate the Benefit of Adjuvant Hormonal Treatment With Leuprorelin Acetate (Eligard® 45 mg) for 24 Months After Radical Prostatectomy in Patients With High Risk of Recurrence.

summary:
PRINCIPAL OBJECTIVE: Evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy in patients with high risk of recurrence.

SECONDARY OBJECTIVE(S):

PSA evolution
Evaluation of testosterone level
Specific survival
Overall survival
Tolerance
Quality of life (QLQ-C30 questionnaires)

lead_sponsor: UNICANCER

sponsor_collaborators:
UNICANCER
Astellas Pharma Inc

location_facility: Centre Hopsitalier Prive - Polyclinique Du Littoral


title: Risk Factors in Sudden Unexpected Death in Epilepsy of the Adults and Children: A Matched Case-control Study

acronym: PRERIES

summary:
Numerous studies over the past decade have shown without any doubt that there is a higher mortality risk in patients with epilepsy than in the general population. The cause of death may be related to the cause of epilepsy, being directly related to a seizure (status epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not necessarily in the presence of witnesses, that is not due to drowning, with or without evidence of a seizure, excluding documented status epilepticus and in which a post-mortem autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP and its mechanisms and risk factors.

This epidemiological study is based on the RSME. The Main objective of this study to identify risk factors of SUDEP, in particular night-time supervision and the risks associated with anti-epileptic drugs including compliance and drug interactions.

status: Unknown status

time_perspective: Retrospective

ReferenceCitation: Donner EJ, Waddell B, Osland K, Leach JP, Duncan S, Nashef L, Picot MC. After sudden unexpected death in epilepsy: Lessons learned and the road forward. Epilepsia. 2016 Jan;57 Suppl 1:46-53. doi: 10.1111/epi.13235.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

collaborators: French Foundation for Epilepsy Research (FFRE)

collaborators: The French League Against Epilepsy (LFCE)

collaborators: Paris AP-HP (La Pitié, St Anne, Necker, Robert Debré)


title: Prospective Study of the Prevention of Vasovagal Reactions in First-time Whole Blood Donors Using a Combined PSYchological and Physiological Approach: PREDONPSY

acronym: PREDONPSY

summary:
The prevention of vasovagal reactions (VVR) occurring during or after donation is a major issue for the French Blood Establishment (EFS), firstly to guarantee the safety of donors but also to retain them, as this reaction is one of the negative experiences affecting the return to donation.

The EVASION study conducted in the Auvergne Rhône-Alpes region (AURA) on 4828 donors representative of the French donor population, reported a beneficial effect of muscle contraction exercises to prevent the occurrence of VVR during donation, while hydric solutions, and even more so isotonic solutions, were likely to decrease the frequency of delayed VVR.

These preventive measures have been integrated into the internal guidelines and currently include muscular and breathing exercises and hydration. Nevertheless, the isotonic solution could not be routinely deployed for feasibility and cost reasons. A salty snack could replace the isotonic solution to produce the same effects with better feasibility and acceptability. Furthermore, a significant proportion of discomfort is psychological in origin, related to stress and anxiety which persist despite these measures, particularly in the first-time donor population.

These measures, which are mainly focused on the prevention of VVR of physiological origin, are still insufficient and can be optimized and complemented to reduce the occurrence of VVR, especially in first-time donors for whom anxiety and stress play an important role in the etiology of VVR.

Two measures could further reduce the occurrence of VVR:

Reinforcement of the physiological strategy: ingestion of a salty snack before donation, the effect of which could be similar to the effect of the isotonic solution, which could not be delivered in practice because of its cost following the data of the EVASION study.
Addition of a psychological strategy: flyer given at the interview presenting the four most frequent fears as well as a description of the recommended muscular and respiratory exercises, followed by the execution of the recommended exercises before the sampling.

Hypothesis is that the combination of a psychological and physiological strategies would allow a reduction of the occurrence of immediate and/or 48 h delayed VVR during the whole blood donation in first time donors compared to the current practices.

primary_purpose: Prevention

lead_sponsor: Hospices Civils de Lyon


title: Multicenter Randomized Phase 2 Trial of Gemcitabine - Platinum With or Without Trastuzumab in Advanced or Metastatic Urothelial Carcinoma With HER2 Overexpression

summary: A multicenter, randomized, Phase 2 trial to study the effectiveness and feasibility of association of trastuzumab with combination chemotherapy in advanced or metastatic bladder cancer patients. Combining monoclonal antibody therapy with combination chemotherapy may improve treatment efficacy on tumours overexpressed HER 2.

ReferenceCitation: Oudard S, Culine S, Vano Y, Goldwasser F, Theodore C, Nguyen T, Voog E, Banu E, Vieillefond A, Priou F, Deplanque G, Gravis G, Ravaud A, Vannetzel JM, Machiels JP, Muracciole X, Pichon MF, Bay JO, Elaidi R, Teghom C, Radvanyi F, Beuzeboc P. Multicentre randomised phase II trial of gemcitabine+platinum, with or without trastuzumab, in advanced or metastatic urothelial carcinoma overexpressing Her2. Eur J Cancer. 2015 Jan;51(1):45-54. doi: 10.1016/j.ejca.2014.10.009. Epub 2014 Nov 15.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility: Centre Hospitalier Départemental de la Vendée

location_facility: Cliniques saint Luc - Université Catholique de Louvain


title: Evaluation of Multidisciplinary Collaboration Care Program in Pulmonary Arterial Hypertension

acronym: ETHAP

summary:
Pulmonary arterial hypertension (PAH) is a severe pulmonary vascular affection, which treatment has evolved in the last few years, improving quality of life. However, adherence to treatment has not been assessed in such patients. The investigators developed a collaborative care model involving clinical pharmacists in PAH. The objective of this work is to evaluate the impact of such model of care on medication errors and adverse events, quality of life and clinical criteria.

This randomized multicentre controlled study will include approximately 100 PAH patients (NYHA II to IV). After inclusion, patients will receive either collaborative care including consultations with specialized pharmacist and nurse, or classic follow-up. Each patient will be followed during 18 months from the date of inclusion.

The investigators hope to show the positive impact of a collaborative care model in PAH. More specifically, the investigators aim to show the interest of long-term patient education to improve patient safety related to drugs, but also their quality of life, and have preliminary data about usual clinical criteria.

ReferenceCitation: Roustit M, Chaumais MC, Chapuis C, Gairard-Dory A, Hadjadj C, Chanoine S, Allenet B, Sitbon O, Pison C, Bedouch P; ETHAP Study Group. Evaluation of a collaborative care program for pulmonary hypertension patients: a multicenter randomized trial. Int J Clin Pharm. 2020 Aug;42(4):1128-1138. doi: 10.1007/s11096-020-01047-8. Epub 2020 May 21.

lead_sponsor: University Hospital, Grenoble

location_facility: Clinical Research Center Inserm CIC03 - Grenoble University Hospital


title: Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent (Development Code TCD-10023) With Biodegradable Polymer at 1, 2 and 3 Months

summary: Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue. The evaluation will be performed by means of intravascular imaging technology (optical frequency domain imaging, OFDI). Renewed tissue coverage over the implanted stent struts prevents direct contact between blood and metal/polymer, which could lead to adverse events: patients need to take blood-thinning drugs to prevent these events. Ous new stent has drug and polymer only on the outside of the stent, and the polymer is degraded by the body leaving a bare metal stent after 3-4 months. This should allow fast coverage of the struts, and might allow to reduce duration of the supportive medical treatment. Our hypothesis is that <20% of the struts remain uncovered at 3 months after implantation, as assessed by OFDI.

ReferenceCitation: Chevalier B, Smits PC, Carrie D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamie D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ. Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months). Circ Cardiovasc Interv. 2017 Dec;10(12):e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801.

repository_institution: University of Zurich - Zurich Open Repository and Archive

lead_sponsor: Terumo Europe N.V.

location_country: Germany Netherlands France

location_facility: Cardiovascular Institute Paris Sud (ICPS)


title: Motor REHAbilitation TEChnologies for CHIldren With Disability

summary: The aim of the RehaTech4Child survey led by EACD is to identify the digital technologies (e.g., robotic devices and treadmill systems, virtual reality and gaming systems, telehealth) that are used in clinical practices throughout Europe, and to know more about how rehabilitation professionals use or not use digital technologies in motor rehabilitation practices within the paediatric population. This knowledge would eventually help in designing the future technological developments based on the feedback from rehabilitation professionals.

time_perspective: Cross-Sectional

ipd_sharing: Undecided

lead_sponsor: University Hospital, Brest

collaborators: National Clinic Center for Neuro-psychomotor Rehabilitation of Children (CNCRNC); Roumanie


acronym: PEACE 6 - Unfit

summary: This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.

sponsor_collaborators: UNICANCER Bayer

location_facility: Centre Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Centro Integral Oncologico HM Clara Campal

location_facility: Fundacion Instituto Valenciano De Oncologia

location_facility: CHU de Poitiers - Pôle Régional de Cancérologie

location_facility: Clinique Sainte Anne - Strasbourg Oncologie Libérale

location_facility: Institut Catala d'Oncologia, Badalona-Hospital Germans Trias i Pujol

location_facility: Grand Hopital de Charleroi - site Notre Dame

location_facility: Centre Hospitalier Intercommunal de Toulon-La Seyne - Hôpital Ste Musse

location_facility: Vall d'Hebron Institute of Oncology. Vall d'Hebron University Hospital

location_facility: Althaia, Xara Assistencial Universitaria Mansera

location_facility: Institut de cancérologie Strasbourg Europe

title: A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents

ipd_sharing_description: IPD can be shared upon request to the sponsor

location_country: Ireland Spain Belgium France

appel_a_projets: PHRCK

nom_etablissement: GCS UNICANCER SIEGE

type_etablissement: GCS

titre: PEACE-6-une plate-forme d'essais randomisés de phase 3 « umbrella » chez les hommes atteints de cancer de la prostate métastatique, mené par le « Prostate Cancer Consortium in Europe » (PEACE)

discipline_principale: cancer

nom_porteur: BACIARELLO

prenom_porteur: Giulia


title: A Phase IIb, Prospective, Multicentre, Double-blind, Triple-arm, Randomized Versus Placebo Trial, to Assess the Efficacy of a Single Injection of Either 2 or 10 x 106 Autologous Adipose Derived Mesenchymal Stromal Cells (ASC) in the Treatment of Mild to Moderate Osteoarthritis (OA) of the Knee, Active and Unresponsive to Conservative Therapy for at Least 12 Months

summary:
ASCs will be administered via intra-articular use into the knee joint affected by OA where they are expected to exert their therapeutic effects.

The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when administered locally into a knee joint affected by OA after in vitro cell expansion. The potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by MRI after 1 and 2 years.

This will be a phase IIb, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous ASC with placebo.

collaborators: National University of Ireland, Galway, Ireland

collaborators: European Clinical Research Infrastructure Network

collaborators: EVANGELISCHES WALDKRANKENHAUS SPANDAU KRANKENHAUSBETRIEBS GGMBH (EWK)

collaborators: Centre National de la Recherche Scientifique, France

collaborators: Cambridge University Hospitals NHS Foundation Trust


title: The Multitasking Rehabilitation She Enhanced Walking Speed Compared to the Simple Post Stroke Rehabilitation Task (AVC)?

acronym: SYNCOMOT

summary:
Stroke is the leading cause of severe disability in adults. The first cause of alterations in the quality of life and autonomy in these patients are disorders of walking and the balance. They are the leading cause of falls responsible for important medical, surgical and economic complications as well as a reactionary social isolation.

The techniques of rehabilitation of walking to the subacute phase of a stroke are usually based on automatic walking.Off walking is a complex activity usually performed in everyday life in association with multiple tasks. It is therefore interesting to re-educate walking in dual task or even in multitasking.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

collaborators: CENTRE DE REEDUCATION FONCTIONNELLE L'ESPOIR LILLE

collaborators: CENTRE DE REEDUCATION FONCTIONNELLE SAINT-LAZARE

collaborators: Centre Régional de Médecine Physique et de Réadaptation - Les herbiers

collaborators: Clinique de rééducation fonctionnelle Le Belloy

appel_a_projets: PHRCI

region: Hauts-de-France

nom_etablissement: CHU AMIENS PICARDIE

type_etablissement: CH

acronyme: SYN-CO-MOT

titre: La rééducation multitache améliore-t-elle la vitesse de la marche par rapport à la rééducation simple tache - Etude randomisée en groupes parallèles

discipline_principale: autre

nom_porteur: TASSEEL-PONCHE

prenom_porteur: Sophie


summary:
In this study, the investigators purpose is to evaluate the adaptation of treatment with early response based on PET scan results after 2 cycles of chemotherapy, for patient aged from 18 to 80 years, with low IPI DLBCL.

This is an open randomized study.

The primary endpoint is to evaluate the 3 years PFS with the aim to demonstrate the non inferiority of the experimental arm in comparison to standard arm:

In standard arm, the patients will receive 6 cycles of R-CHOP 21 without taking into account of PET scan results after 2 cycles.

In experimental arm, early good responder patients (defined as having a negative PET scan after 2 cycles, confirmed after 4 cycles) will receive only 4 cycles of R-CHOP 21.

In both arms, if the PET scan remains positive after 4 cycles of chemotherapy, a biopsy exam is needed to confirm the failure and an intensive chemotherapy is then recommended.

All of the patients, in both arms, will have an early evaluation with PET scan. All PET scan will be reviewed by a group of expert according to Deauville criteria defined by Meignan et al to adapt the decision after the 2nd cycle in experimental arm and after the 4th cycle for all patients. The final evaluation of response will be made according to 2007 Cheson's criteria.

sponsor_collaborators: The Lymphoma Academic Research Organisation

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: CH de Saint-Brieuc - Hôpital Yves Le Foll

location_facility: Hôpital Saint Antoine, Service d'hématologie du Pr Marie

location_facility: Université Catholique de Louvain Saint Luc

location_facility: Centre Hospitalier de Wallonie Picarde - CHwapi

location_facility: Université Libre de Bruxelles - Hôpital Erasme

title: Randomized Phase III Study Evaluating the Non-inferiority of a Treatment Adapted to the Early Response Evaluated With 18F-FDG PET Compared to a Standard Treatment, for Patients Aged From 18 to 80 Years With Low Risk (aa IPI = 0) Diffuse Large B-cells Non Hodgkin's Lymphoma CD 20+


title: Molecular and Cellular Print Medical Device Validation in Adult Glioma Tumors

acronym: ProTool

summary: The purpose of the study is to determine the clinical safety and operability of the innovative tissue imprint device ProTool.

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Henri Mondor University Hospital
Angers University Hospital
Grenoble University Hospital
CLINATEC
Sainte-Anne Hospital


title: Urinary Postpartum Handicap Prevention: Pelvic Floor Exercises vs Control. Multicentric Randomized Trial

summary:
Objective: Compare pelvic floor disorders (urinary incontinence, anal incontinence, genital prolapse, perineal pain, sexual troubles) 12 month after a first delivery between a group of women with prenatal pelvic floor exercises and a control group.

Hypothesis: Prenatal pelvic floor exercises reduce postpartum urinary incontinence.

ReferenceCitation: Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.

ReferenceCitation: Fritel X, de Tayrac R, Bader G, Savary D, Gueye A, Deffieux X, Fernandez H, Richet C, Guilhot J, Fauconnier A. Preventing Urinary Incontinence With Supervised Prenatal Pelvic Floor Exercises: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):370-377. doi: 10.1097/AOG.0000000000000972.

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

lead_sponsor: Centre Hospitalier Universitaire de la Réunion

location_facility:
CHR Réunion, CH Félix-Guyon
CH Poissy-Saint-Germain
CHU Antoine-Béclère
CHU Clermont
CHU Caremeau


title: Use of Botulinum Toxin (BTX) for the Treatment of Peripheral Painful Traumatic Trigeminal Neuropathy (PPTTN)

acronym: TRIGTOX

summary: Peripheral painful traumatic trigeminal neuropathy (PPTTN) are poorly relieved by existing treatments which in addition induce many adverse effects. BTX, which blocks the exocytosis of neurotransmitters, can be captured by axonal retrograde transport in primary nociceptive neurons. Injected in the painful area, it might therefore inhibit the release of algogenic neurotransmitters, at both the peripheral and central levels and thus reduce pain. One study reported such an effect in neuropathic spinal pain. A recent study reported an analgesic effect in trigeminal neuralgia.

ReferenceCitation: Moreau N, Dieb W, Descroix V, Svensson P, Ernberg M, Boucher Y. Topical Review: Potential Use of Botulinum Toxin in the Management of Painful Posttraumatic Trigeminal Neuropathy. J Oral Facial Pain Headache. 2017 Winter;31(1):7-18. doi: 10.11607/ofph.1753.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Karolinska Institutet
University of Aarhus

acronyme: TRIGTOX

titre: Utilisation de la toxine botulique dans le traitement des douleurs neuropathiques périphériques trigéminales post-traumatiques (DNPTP)

discipline_principale: odontologie

nom_porteur: BOUCHER

prenom_porteur: Yves


title: A Clinical Evaluation of the XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Women With de Novo Coronary Artery Lesions

summary: The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

design_allocation: Non-Randomized

ReferenceCitation: Morice MC. XIENCE V SPIRIT WOMEN clinical trial: characterization of the female population undergoing stent implantation. Womens Health (Lond). 2008 Sep;4(5):439-43. doi: 10.2217/17455057.4.5.439.

ReferenceCitation: Genereux P, Rutledge DR, Palmerini T, Caixeta A, Kedhi E, Hermiller JB, Wang J, Krucoff MW, Jones-McMeans J, Sudhir K, Simonton CA, Serruys PW, Stone GW. Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents: Insights From the Xience V Coronary Stent System Trials. Circ Cardiovasc Interv. 2015 May;8(5):e001362. doi: 10.1161/CIRCINTERVENTIONS.114.001362.

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Poland
Argentina
Australia
Brazil
France
Portugal
Hungary
Denmark
Switzerland
Latvia
India
Belgium
China
Malaysia
Italy
Norway
United Kingdom
Venezuela
Netherlands
Austria
Spain
Greece
South Africa
Russian Federation
Israel

location_facility: A.O. Universitaria Tor Vergata, Cardiologia

location_facility: Institut Hospitalier Jacques Cartier Service d'Angiographie, Inst Cardiovasculaire Paris-Sud

location_facility: Polsko Amerykanskie-Kliniki Serca American Heart

location_facility: Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia

location_facility: Instituto Cardiovascular de Buenos Aires-ICBA

location_facility: Latvian Center of Cardiology, P. Stradina University Hospital

location_facility: Bakulev Scientific Center for Cardiovascular Surgery

location_facility: Clinico S.Ambrogio, GRUPPO OSPEDALIERO SAN DONATO

location_facility: Klinikum der Johannes Gutenberg-Universität II. Medizinische Klinik und Poliklinik

location_facility: L'Azienda di Rilievo Nazionale di Alta Specializzazione (A.R.N.A.S.) Civico e Benfratelli

location_facility: Hospital Clinico San Carlos, Hemodynamics Department

location_facility: Technische Universität Dresden, Medizinische Klinik II - Kardiologie

location_facility: Centre Cardio-Pneumologique - Hôpital Pontchaillou - CHU

location_facility: Max Devki Devi Heart & Vascular Insititute, Department of Cardiology

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Cardiology Clinic of Papageorgiou Hospital

location_facility: Kardiologische Klinik Herz- und Diabeteszentrum

location_facility: Semmelweis University, Department of Cardiovascular Surgery

location_facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences

location_facility: Escorts Heart Institute & Research Centre

location_facility: Allgemeines Krankenhaus der Stadt Wien - Univ.Klinik f. Innere Medizin II

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: H. Miguel Servet. Zaragoza, Cardiology Service

location_facility: Medizinische Hochschule Hannover Abteilung Kardiologie Und Angiologie

location_facility: Hosital Italiano de Buenos Aires - Cardiologia

location_facility: INCOR/SP Instituto do Coração - Hospital das Clinicas - FMUSP

location_facility: University of Pécs/Medical School/Heart Institute

location_facility: Universitäres Herzzentrum, Medizinische Klinik III

location_facility: Hospital Moinhos de Ventos-Centro de Cardiologia

location_facility: Azienda Policlinico di Modena U.O. Cardiologia, Ospedale di Modena

location_facility: China People Liberation Army (PLA) General Hospital


title: Conservative Treatments of Retinoblastoma

summary:
Conservative treatments of retinoblastoma (RETINO 2011)

-Multicentric non randomised, phase II study for the patients treated by chemoreduction (VP16, carboplatin) followed by chemothermotherapy without laser treatment at day 8
-Multicentric non randomised, phase II study for the patients with bilateral very asymmetric dis-ease (Group D eye on one of the eye) or unilateral presentation groups B/C/D according to the age and vitreous seeding
- Multicentric non randomised, phase II study for the patients treated by 6 cycles of three drugs regimen and local treatments for bilateral group D eyes or on the only eye.

lead_sponsor: Institut Curie

sponsor_collaborators:
Institut Curie
Fondation Rothschild Paris