title: Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform: Evolution of the Therapeutic Care in Metastatic Breast Cancer Across the French Comprehensive Cancer Centers From 2008

acronym: ESME-MBC

summary: The Epidemiological Strategy and Medical Economic (ESME) Ovarian cancer Data Platform is a multi-center real life database using a retrospective data collection process (18 FCCCs over 20 sites). This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records.

ReferenceType: result

ReferenceCitation: Delaloge S, Perol D, Courtinard C, Brain E, Asselain B, Bachelot T, Debled M, Dieras V, Campone M, Levy C, Jacot W, Lorgis V, Veyret C, Dalenc F, Ferrero JM, Uwer L, Kerbrat P, Goncalves A, Mouret-Reynier MA, Petit T, Jouannaud C, Vanlemmens L, Chenuc G, Guesmia T, Robain M, Cailliot C. Paclitaxel plus bevacizumab or paclitaxel as first-line treatment for HER2-negative metastatic breast cancer in a multicenter national observational study. Ann Oncol. 2016 Sep;27(9):1725-32. doi: 10.1093/annonc/mdw260. Epub 2016 Jul 19.

oa_host_type: publisher

evidence: open (via crossref license)

ReferenceCitation: Jacquet E, Lardy-Cleaud A, Pistilli B, Franck S, Cottu P, Delaloge S, Debled M, Vanlemmens L, Leheurteur M, Guizard AV, Laborde L, Uwer L, Jacot W, Berchery D, Desmoulins I, Ferrero JM, Perrocheau G, Courtinard C, Brain E, Chabaud S, Robain M, Bachelot T. Endocrine therapy or chemotherapy as first-line therapy in hormone receptor-positive HER2-negative metastatic breast cancer patients. Eur J Cancer. 2018 May;95:93-101. doi: 10.1016/j.ejca.2018.03.013. Epub 2018 Apr 11.

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

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

ReferenceCitation: Gobbini E, Ezzalfani M, Dieras V, Bachelot T, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Cleaud AL, Robain M, Courtinard C, Cailliot C, Perol D, Delaloge S. Time trends of overall survival among metastatic breast cancer patients in the real-life ESME cohort. Eur J Cancer. 2018 Jun;96:17-24. doi: 10.1016/j.ejca.2018.03.015. Epub 2018 Apr 13.

ReferenceCitation: Cabel L, Carton M, Cheaib B, Pierga JY, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Desmoulins I, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Perrocheau G, Piot I, Perol D, Simon G, Lerebours F. Oral etoposide in heavily pre-treated metastatic breast cancer: results from the ESME cohort and comparison with other chemotherapy regimens. Breast Cancer Res Treat. 2019 Jan;173(2):397-406. doi: 10.1007/s10549-018-5017-2. Epub 2018 Oct 24.

ReferenceCitation: Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Mazouni C, Mailliez A, Pasquier D, Madranges N, Firmin N, Crouzet A, Goncalves A, Jankowski C, De La Motte Rouge T, Pouget N, de La Lande B, Mouttet-Boizat D, Ferrero JM, Uwer L, Eymard JC, Mouret-Reynier MA, Petit T, Robain M, Filleron T, Cailliot C, Dalenc F. Survival Impact of Locoregional Treatment of the Primary Tumor in De Novo Metastatic Breast Cancers in a Large Multicentric Cohort Study: A Propensity Score-Matched Analysis. Ann Surg Oncol. 2019 Feb;26(2):356-365. doi: 10.1245/s10434-018-6831-9. Epub 2018 Dec 11.

ReferenceCitation: Delaloge S, Perol D, Robain M, Cailliot C. Reply to 'The potential and perils of observational studies' by M. Buyse et al. Ann Oncol. 2017 Feb 1;28(2):436-437. doi: 10.1093/annonc/mdw572. No abstract available.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Perol D, Robain M, Delaloge S, Cailliot C. Routinely collected data may usefully supplement randomised controlled data on treatment effects for mortality. BMJ. 2016 Dec 16;355:i6745. doi: 10.1136/bmj.i6745. No abstract available.

ReferenceCitation: Petitjean A, Smith-Palmer J, Valentine W, Tehard B, Roze S. Cost-effectiveness of bevacizumab plus paclitaxel versus paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer in specialist oncology centers in France. BMC Cancer. 2019 Feb 11;19(1):140. doi: 10.1186/s12885-019-5335-8.

ReferenceCitation: Perol D, Robain M, Arveux P, Mathoulin-Pelissier S, Chamorey E, Asselain B, Berchery D, Gourgou S, Breton M, Delaine-Clisant S, Mons M, Dieras V, Carton M, Guizard AV, Laborde L, Laurent C, Loeb A, Mouret-Reynier MA, Parent D, Perrocheau G, Campion L, Velten M, Cailliot C, Ezzalfani M, Simon G. The ongoing French metastatic breast cancer (MBC) cohort: the example-based methodology of the Epidemiological Strategy and Medical Economics (ESME). BMJ Open. 2019 Feb 21;9(2):e023568. doi: 10.1136/bmjopen-2018-023568.

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

ReferenceCitation: Jacot W, Heudel PE, Fraisse J, Gourgou S, Guiu S, Dalenc F, Pistilli B, Campone M, Levy C, Debled M, Leheurteur M, Chaix M, Lefeuvre C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Courtinard C, Cottu P, Robain M, Mailliez A. Real-life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program. Int J Cancer. 2019 Dec 15;145(12):3359-3369. doi: 10.1002/ijc.32402. Epub 2019 Jun 20.

ReferenceCitation: Le Saux O, Lardy-Cleaud A, Frank S, Debled M, Cottu PH, Pistilli B, Vanlemmens L, Leheurteur M, Levy C, Laborde L, Uwer L, D'hondt V, Berchery D, Lorgis V, Ferrero JM, Perrocheau G, Courtinard C, Mouret-Reynier MA, Velten M, Breton M, Parent D, Chabaud S, Robain M, Bachelot T. Assessment of the efficacy of successive endocrine therapies in hormone receptor-positive and HER2-negative metastatic breast cancer: a real-life multicentre national study. Eur J Cancer. 2019 Sep;118:131-141. doi: 10.1016/j.ejca.2019.06.014. Epub 2019 Jul 19.

ReferenceCitation: Gougis P, Carton M, Tchokothe C, Campone M, Dalenc F, Mailliez A, Levy C, Jacot W, Debled M, Leheurteur M, Bachelot T, Hennequin A, Perrin C, Goncalves A, Uwer L, Eymard JC, Petit T, Mouret-Reynier MA, Chamorey E, Simon G, Saghatchian M, Cailliot C, Le Tourneau C. CineBreast-factors influencing the time to first metastatic recurrence in breast cancer: Analysis of real-life data from the French ESME MBC database. Breast. 2020 Feb;49:17-24. doi: 10.1016/j.breast.2019.10.004. Epub 2019 Oct 19.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

ReferenceCitation: Darlix A, Louvel G, Fraisse J, Jacot W, Brain E, Debled M, Mouret-Reynier MA, Goncalves A, Dalenc F, Delaloge S, Campone M, Augereau P, Ferrero JM, Levy C, Fumet JD, Lecouillard I, Cottu P, Petit T, Uwer L, Jouannaud C, Leheurteur M, Dieras V, Robain M, Chevrot M, Pasquier D, Bachelot T. Impact of breast cancer molecular subtypes on the incidence, kinetics and prognosis of central nervous system metastases in a large multicentre real-life cohort. Br J Cancer. 2019 Dec;121(12):991-1000. doi: 10.1038/s41416-019-0619-y. Epub 2019 Nov 13.

ReferenceCitation: Pasquier D, Darlix A, Louvel G, Fraisse J, Jacot W, Brain E, Petit A, Mouret-Reynier MA, Goncalves A, Dalenc F, Deluche E, Fresnel JS, Augereau P, Ferrero JM, Geffrelot J, Fumet JD, Lecouillard I, Cottu P, Petit T, Uwer L, Jouannaud C, Leheurteur M, Dieras V, Robain M, Mouttet-Audouard R, Bachelot T, Courtinard C. Treatment and outcomes in patients with central nervous system metastases from breast cancer in the real-life ESME MBC cohort. Eur J Cancer. 2020 Jan;125:22-30. doi: 10.1016/j.ejca.2019.11.001. Epub 2019 Dec 10.

ReferenceCitation: Deluche E, Antoine A, Bachelot T, Lardy-Cleaud A, Dieras V, Brain E, Debled M, Jacot W, Mouret-Reynier MA, Goncalves A, Dalenc F, Patsouris A, Ferrero JM, Levy C, Lorgis V, Vanlemmens L, Lefeuvre-Plesse C, Mathoulin-Pelissier S, Petit T, Uwer L, Jouannaud C, Leheurteur M, Lacroix-Triki M, Courtinard C, Perol D, Robain M, Delaloge S. Contemporary outcomes of metastatic breast cancer among 22,000 women from the multicentre ESME cohort 2008-2016. Eur J Cancer. 2020 Apr;129:60-70. doi: 10.1016/j.ejca.2020.01.016. Epub 2020 Mar 2.

ReferenceCitation: Pons-Tostivint E, Kirova Y, Lusque A, Campone M, Geffrelot J, Rivera S, Mailliez A, Pasquier D, Madranges N, Firmin N, Crouzet A, Goncalves A, Jankowski C, De La Motte Rouge T, Pouget N, De La Lande B, Mouttet-Boizat D, Ferrero JM, Uwer L, Eymard JC, Mouret-Reynier MA, Petit T, Courtinard C, Filleron T, Robain M, Dalenc F. Radiation therapy to the primary tumor for de novo metastatic breast cancer and overall survival in a retrospective multicenter cohort analysis. Radiother Oncol. 2020 Apr;145:109-116. doi: 10.1016/j.radonc.2019.12.019. Epub 2020 Jan 10.

ReferenceCitation: Heudel P, Delaloge S, Parent D, Madranges N, Levy C, Dalenc F, Brain E, Uwer L, D'Hondt V, Augereau P, Mailliez A, Perrin C, Frenel JS, Sablin MP, Mouret-Reynier MA, Vermeulin T, Eymard JC, Petit T, Ferrero JM, Ilie S, Goncalves A, Chenuc G, Robain M, Simon G, Perol D. Real-world Evaluation of Oral Vinorelbine in the Treatment of Metastatic Breast Cancer: An ESME-MBC Study. Anticancer Res. 2020 Jul;40(7):3905-3913. doi: 10.21873/anticanres.14381.

ReferenceCitation: Frasca M, Sabathe C, Delaloge S, Galvin A, Patsouris A, Levy C, Mouret-Reynier MA, Desmoulins I, Vanlemmens L, Bachelot T, Goncalves A, Perotin V, Uwer L, Frenel JS, Ferrero JM, Bouleuc C, Eymard JC, Dieras V, Leheurteur M, Petit T, Dalenc F, Jaffre A, Chevrot M, Courtinard C, Mathoulin-Pelissier S. Palliative care delivery according to age in 12,000 women with metastatic breast cancer: Analysis in the multicentre ESME-MBC cohort 2008-2016. Eur J Cancer. 2020 Sep;137:240-249. doi: 10.1016/j.ejca.2020.07.007. Epub 2020 Aug 14.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

ReferenceCitation: Frank S, Carton M, Dubot C, Campone M, Pistilli B, Dalenc F, Mailliez A, Levy C, D'Hondt V, Debled M, Vermeulin T, Coudert B, Perrin C, Goncalves A, Uwer L, Ferrero JM, Eymard JC, Petit T, Mouret-Reynier MA, Patsouris A, Guesmia T, Bachelot T, Robain M, Cottu P. Impact of age at diagnosis of metastatic breast cancer on overall survival in the real-life ESME metastatic breast cancer cohort. Breast. 2020 Aug;52:50-57. doi: 10.1016/j.breast.2020.04.009. Epub 2020 Apr 23.

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

ReferenceCitation: Saleh K, Carton M, Dieras V, Heudel PE, Brain E, D'Hondt V, Mailliez A, Patsouris A, Mouret-Reynier MA, Goncalves A, Ferrero JM, Petit T, Emile G, Uwer L, Debled M, Dalenc F, Jouannaud C, Ladoire S, Leheurteur M, Cottu P, Veron L, Savignoni A, Courtinard C, Robain M, Delaloge S, Deluche E. Impact of body mass index on overall survival in patients with metastatic breast cancer. Breast. 2021 Feb;55:16-24. doi: 10.1016/j.breast.2020.11.014. Epub 2020 Dec 1.

ReferenceCitation: Sirieix J, Fraisse J, Mathoulin-Pelissier S, Leheurteur M, Vanlemmens L, Jouannaud C, Dieras V, Levy C, Ung M, Mouret-Reynier MA, Petit T, Coudert B, Brain E, Pistilli B, Ferrero JM, Goncalves A, Uwer L, Patsouris A, Tredan O, Courtinard C, Gourgou S, Frenel JS. Management and outcome of male metastatic breast cancer in the national multicenter observational research program Epidemiological Strategy and Medical Economics (ESME). Ther Adv Med Oncol. 2020 Dec 23;12:1758835920980548. doi: 10.1177/1758835920980548. eCollection 2020.

ReferenceCitation: Bertho M, Fraisse J, Patsouris A, Cottu P, Arnedos M, Perol D, Jaffre A, Goncalves A, Lebitasy MP, D'Hondt V, Dalenc F, Ferrero JM, Levy C, Dabakuyo S, Rouzier R, Penault-Llorca F, Uwer L, Eymard JC, Breton M, Chevrot M, Thureau S, Petit T, Simon G, Frenel JS. Real-life prognosis of 5041 bone-only metastatic breast cancer patients in the multicenter national observational ESME program. Ther Adv Med Oncol. 2021 Jan 21;13:1758835920987657. doi: 10.1177/1758835920987657. eCollection 2021.

ReferenceCitation: Cabel L, Carton M, Pistilli B, Dalenc F, Vanlemnens L, Levy C, Jacot W, Debled M, Loeb A, Hennequin A, De la Motte Rouge T, Laborde L, Laurent C, Chamorey E, Parent D, Petit T, Mouret-Reynier MA, Campone M, Perrocheau G, Labreveux C, Bachelot T, Robain M, Lerebours F. Outcome beyond third-line chemotherapy for metastatic triple-negative breast cancer in the French ESME program. Breast. 2021 Apr;56:18-25. doi: 10.1016/j.breast.2021.01.006. Epub 2021 Jan 30.

ReferenceCitation: Hotton J, Lusque A, Leufflen L, Campone M, Levy C, Honart JF, Mailliez A, Debled M, Gutowski M, Leheurteur M, Goncalves A, Jankowski C, Guillermet S, Bachelot T, Ferrero JM, Eymard JC, Petit T, Pouget N, de La Lande B, Frenel JS, Villacroux O, Simon G, Pons-Tostivint E, Marchai F. Early Locoregional Breast Surgery and Survival in de novo Metastatic Breast Cancer in the Multicenter National ESME Cohort. Ann Surg. 2023 Jan 1;277(1):e153-e161. doi: 10.1097/SLA.0000000000004767. Epub 2021 Feb 1.

ReferenceCitation: Annonay M, Gauquelin L, Geiss R, Ung M, Cristol-Dalstein L, Mouret-Reynier MA, Goncalves A, Abadie-Lacourtoisie S, Francois E, Perrin C, Le Fel J, Lorgis V, Servent V, Uwer L, Jouannaud C, Leheurteur M, Joly F, Campion L, Courtinard C, Villacroux O, Petit T, Soubeyran P, Terret C, Bellera C, Brain E, Delaloge S. Treatment and outcomes of older versus younger women with HER2-positive metastatic breast cancer in the real-world national ESME database. Breast. 2021 Dec;60:138-146. doi: 10.1016/j.breast.2021.09.011. Epub 2021 Oct 1.

ReferenceCitation: Carausu M, Carton M, Darlix A, Pasquier D, Leheurteur M, Debled M, Mouret-Reynier MA, Goncalves A, Dalenc F, Verret B, Campone M, Augereau P, Ferrero JM, Levy C, Fumet JD, Lefeuvre-Plesse C, Petit T, Uwer L, Jouannaud C, Larrouquere L, Chevrot M, Courtinard C, Cabel L. Breast cancer patients treated with intrathecal therapy for leptomeningeal metastases in a large real-life database. ESMO Open. 2021 Jun;6(3):100150. doi: 10.1016/j.esmoop.2021.100150. Epub 2021 May 10.

ReferenceCitation: Corbaux P, Lardy-Cleaud A, Alexandre M, Fontanilles M, Levy C, Viansone AA, Mailliez A, Debled M, Goncalves A, Le Du F, Lerebours F, Ferrero JM, Eymard JC, Mouret-Reynier MA, Petit T, Frenel JS, Dalenc F, Courtinard C, Chaix M, Bachelot T. Progression-free survival on endocrine therapy, before or after chemotherapy, in hormone receptor-positive HER2-negative metastatic breast cancer. Breast Cancer Res Treat. 2022 Jan;191(1):191-207. doi: 10.1007/s10549-021-06382-6. Epub 2021 Oct 23.

ReferenceCitation: Dano D, Lardy-Cleaud A, Monneur A, Quenel-Tueux N, Levy C, Mouret-Reynier MA, Coudert B, Mailliez A, Ferrero JM, Guiu S, Campone M, de La Motte Rouge T, Petit T, Pistilli B, Dalenc F, Simon G, Lerebours F, Chabaud S, Bertucci F, Goncalves A. Metastatic inflammatory breast cancer: survival outcomes and prognostic factors in the national, multicentric, and real-life French cohort (ESME). ESMO Open. 2021 Aug;6(4):100220. doi: 10.1016/j.esmoop.2021.100220. Epub 2021 Jul 22.

ReferenceCitation: Ezzalfani M, Porcher R, Savignoni A, Delaloge S, Filleron T, Robain M, Perol D; ESME Group. Addressing the issue of bias in observational studies: Using instrumental variables and a quasi-randomization trial in an ESME research project. PLoS One. 2021 Sep 15;16(9):e0255017. doi: 10.1371/journal.pone.0255017. eCollection 2021.

ReferenceCitation: Gaillard T, Carton M, Mailliez A, Desmoulins I, Mouret-Reynier MA, Petit T, Leheurteur M, Dieras V, Ferrero JM, Uwer L, Guiu S, Goncalves A, Levy C, Debled M, Dalenc F, Patsouris A, Bachelot T, Eymard JC, Chevrot M, Conversano A, Robain M, Hequet D. De novo metastatic breast cancer in patients with a small locoregional tumour (T1-T2/N0): Characteristics and prognosis. Eur J Cancer. 2021 Oct 21;158:181-188. doi: 10.1016/j.ejca.2021.09.021. Online ahead of print. Erratum In: Eur J Cancer. 2022 May;166:311-312.

ReferenceCitation: Grinda T, Antoine A, Jacot W, Blaye C, Cottu PH, Dieras V, Dalenc F, Goncalves A, Debled M, Patsouris A, Mouret-Reynier MA, Mailliez A, Clatot F, Levy C, Ferrero JM, Desmoulins I, Uwer L, Petit T, Jouannaud C, Lacroix-Triki M, Deluche E, Robain M, Courtinard C, Bachelot T, Brain E, Perol D, Delaloge S. Evolution of overall survival and receipt of new therapies by subtype among 20 446 metastatic breast cancer patients in the 2008-2017 ESME cohort. ESMO Open. 2021 Jun;6(3):100114. doi: 10.1016/j.esmoop.2021.100114. Epub 2021 Apr 23.

ReferenceCitation: Grinda T, Joyon N, Lusque A, Lefevre S, Arnould L, Penault-Llorca F, Macgrogan G, Treilleux I, Vincent-Salomon A, Haudebourg J, Maran-Gonzalez A, Charafe-Jauffret E, Courtinard C, Franchet C, Verriele V, Brain E, Tas P, Blanc-Fournier C, Leroux A, Loussouarn D, Berghian A, Brabencova E, Ghnassia JP, Scoazec JY, Delaloge S, Filleron T, Lacroix-Triki M. Phenotypic discordance between primary and metastatic breast cancer in the large-scale real-life multicenter French ESME cohort. NPJ Breast Cancer. 2021 Apr 16;7(1):41. doi: 10.1038/s41523-021-00252-6.

ReferenceCitation: Bringuier M, Carton M, Levy C, Patsouris A, Pasquier D, Debled M, Rigal O, Jacot W, Goncalves A, Desmoulins I, De La Motte Rouge T, Bachelot T, Ferrero JM, Eymard JC, Ung M, Mouret-Reynier MA, Petit T, Chevrot M, Uwer L, Courtinard C, Frenel JS, Vianzone A, Baldini C. Enrollment of older metastatic breast cancer patients in first-line clinical trials: 9-year experience of the large-scale real-life multicenter French ESME cohort. Breast Cancer Res Treat. 2022 Feb;191(3):577-587. doi: 10.1007/s10549-021-06467-2. Epub 2022 Jan 5.

ReferenceCitation: Carausu M, Carton M, Cabel L, Patsouris A, Levy C, Verret B, Pasquier D, Debled M, Goncalves A, Desmoulins I, Lecouillard I, Bachelot T, Ferrero JM, Eymard JC, Mouret-Reynier MA, Chevrot M, De Maio E, Uwer L, Frenel JS, Leheurteur M, Petit T, Darlix A, Bozec L. Clinicopathological characteristics and prognosis of breast cancer patients with isolated central nervous system metastases in the multicentre ESME database. Ther Adv Med Oncol. 2022 Feb 26;14:17588359221077082. doi: 10.1177/17588359221077082. eCollection 2022.

ReferenceCitation: Dalenc F, Lusque A, De La Motte Rouge T, Pistilli B, Brain E, Pasquier D, Debled M, Thery JC, Goncalves A, Desmoulins I, Levy C, Uwer L, Ferrero JM, Eymard JC, Mouret-Reynier MA, Patsouris A, Frenel JS, Petit T, Chevrot M, Bachelot T, Guiu S. Impact of lobular versus ductal histology on overall survival in metastatic breast cancer: a French retrospective multicentre cohort study. Eur J Cancer. 2022 Mar;164:70-79. doi: 10.1016/j.ejca.2021.12.031. Epub 2022 Feb 14.

ReferenceCitation: Mallet A, Lusque A, Levy C, Pistilli B, Brain E, Pasquier D, Debled M, Thery JC, Goncalves A, Desmoulins I, De La Motte Rouge T, Faure C, Ferrero JM, Eymard JC, Mouret-Reynier MA, Patsouris A, Cottu P, Dalenc F, Petit T, Payen O, Uwer L, Guiu S, Frenel JS. Real-world evidence of the management and prognosis of young women (⩽40 years) with de novo metastatic breast cancer. Ther Adv Med Oncol. 2022 Jan 21;14:17588359211070362. doi: 10.1177/17588359211070362. eCollection 2022.

ReferenceCitation: Moinard-Butot F, Saint-Martin C, Pflumio C, Carton M, Jacot W, Cottu PH, Dieras V, Dalenc F, Goncalves A, Debled M, Patsouris A, Mouret-Reynier MA, Vanlemmens L, Leheurteur M, Emile G, Ferrero JM, Desmoulins I, Uwer L, Eymard JC, Cheaib B, Courtinard C, Bachelot T, Chevrot M, Petit T. Efficacy of trastuzumab emtansine (T-DM1) and lapatinib after dual HER2 inhibition with trastuzumab and pertuzumab in patient with metastatic breast cancer: Retrospective data from a French multicenter real-life cohort. Breast. 2022 Jun;63:54-60. doi: 10.1016/j.breast.2022.03.004. Epub 2022 Mar 11.

ReferenceCitation: Vasseur A, Carton M, Guiu S, Augereau P, Uwer L, Mouret-Reynier MA, Levy C, Eymard JC, Ferrero JM, Leheurteur M, Goncalves A, Robert M, De La Motte Rouge T, Bachelot T, Petit T, Debled M, Grinda T, Desmoulins I, Vanlemmens L, Nicolai V, Simon G, Cabel L. Efficacy of taxanes rechallenge in first-line treatment of early metastatic relapse of patients with HER2-negative breast cancer previously treated with a (neo)adjuvant taxanes regimen: A multicentre retrospective observational study. Breast. 2022 Oct;65:136-144. doi: 10.1016/j.breast.2022.07.014. Epub 2022 Aug 4.

ReferenceCitation: Jacot W, Lusque A, Vicier C, Mailliez A, de La Motte Rouge T, Cabel L, Levy C, Patsouris A, Desmoulins I, Uwer L, Thery JC, Robain M, Caron O, Tredan O, Filleron T, Frenel JS, Delaloge S. Outcomes of patients with HER2-negative metastatic breast cancer after platinum- and non-platinum-based first-line chemotherapy among patients with and without pathogenic germline BRCA1/2 mutations. Br J Cancer. 2022 Nov;127(11):1963-1973. doi: 10.1038/s41416-022-02003-1. Epub 2022 Oct 7.

ReferenceCitation: Mailliez A, D'Hondt V, Lusque A, Caron O, Cabel L, Goncalves A, Debled M, Gladieff L, Ferrero JM, Petit T, Mouret-Reynier MA, Eymard JC, Levy C, Uwer L, Leheurteur M, Desmoulins I, Bachelot T, Frenel JS, de la Motte Rouge T, Simon G, Jacot W, Delaloge S. Survival outcomes of metastatic breast cancer patients by germline BRCA1/2 status in a large multicenter real-world database. Int J Cancer. 2023 Mar 1;152(5):921-931. doi: 10.1002/ijc.34304. Epub 2022 Oct 8.

ReferenceCitation: de Calbiac O, Lusque A, Mailliez A, Bachelot T, Uwer L, Mouret-Reynier MA, Emile G, Jouannaud C, Goncalves A, Patsouris A, Dieras V, Leheurteur M, Petit T, Cottu P, Ferrero JM, D'Hondt V, Desmoulins I, Mourato-Ribeiro J, Martin AL, Frenel JS. Comparison of Management and Outcomes in ERBB2-Low vs ERBB2-Zero Metastatic Breast Cancer in France. JAMA Netw Open. 2022 Sep 1;5(9):e2231170. doi: 10.1001/jamanetworkopen.2022.31170.

ReferenceCitation: Carausu M, Carton M, Dieras V, Petit T, Guiu S, Goncalves A, Augereau P, Ferrero JM, Levy C, Ung M, Desmoulins I, Debled M, Bachelot T, Pistilli B, Frenel JS, Mailliez A, Chevrot M, Cabel L. Association of Endocrine Therapy for HR+/ERBB2+ Metastatic Breast Cancer With Survival Outcomes. JAMA Netw Open. 2022 Dec 1;5(12):e2247154. doi: 10.1001/jamanetworkopen.2022.47154.

ReferenceCitation: Collet L, Eberst L, Ludovic G, Debled M, Hrab L, Mouret-Reynier MA, Desmoulins I, Goncalves A, Campone M, Ferrero JM, Brain E, Uwer L, Eymard JC, Dieras V, Simon G, Leheurteur M, Dalenc F, Vanlemmens L, Darlix A, Arnedos M, Bachelot T. Clinical outcome of patients with isolated central nervous system progression on first-line pertuzumab and trastuzumab treatment for HER2-positive metastatic breast cancer in a real-life cohort. Breast Cancer. 2023 Mar;30(2):329-341. doi: 10.1007/s12282-022-01427-0. Epub 2023 Jan 11.

ReferenceCitation: Francois-Martin H, Lardy-Cleaud A, Pistilli B, Levy C, Dieras V, Frenel JS, Guiu S, Mouret-Reynier MA, Mailliez A, Eymard JC, Petit T, Ung M, Desmoulins I, Augereau P, Bachelot T, Uwer L, Debled M, Ferrero JM, Clatot F, Goncalves A, Chevrot M, Chabaud S, Cottu P. Long-Term Results with Everolimus in Advanced Hormone Receptor Positive Breast Cancer in a Multicenter National Real-World Observational Study. Cancers (Basel). 2023 Feb 13;15(4):1191. doi: 10.3390/cancers15041191.

ReferenceCitation: Courtinard C, Gourgou S, Jacot W, Carton M, Guerin O, Vacher L, Bertaut A, Le Deley MC, Perol D, Marino P, Levy C, Uwer L, Perrocheau G, Schiappa R, Bachelot F, Parent D, Breton M, Petit T, Filleron T, Loeb A, Pelissier SM, Robain M, Delaloge S, Bellera C. Association between progression-free survival and overall survival in women receiving first-line treatment for metastatic breast cancer: evidence from the ESME real-world database. BMC Med. 2023 Mar 8;21(1):87. doi: 10.1186/s12916-023-02754-5.

sponsor_collaborators:
UNICANCER
Roche Pharma AG
Pierre Fabre Laboratories
Pfizer
AstraZeneca
Merck Sharp & Dohme LLC
Eisai Inc.
Daiichi Sankyo, Inc.
Eli Lilly and Company
Gilead Sciences
Seagen Inc.

location_facility: Institut régional du Cancer Montpellier / Val d'Aurelle

location_facility: Institut de cancérologie de l'Ouest - René Gauducheau

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


title: Epidemiological Strategy and Medical Economic (ESME) Research Program / Academic Real World Data Platform : Evolution of the Therapeutic Care in Ovarian Cancer Across the French Comprehensive Cancer Centers From 2011

acronym: ESME-OVR

summary: The ESME OVR Data Platform is a multi-center real life database using a retrospective data collection process in 18 French Comprehensive Cancer Center (FCCC) over 20 sites). This database compiles data from Patient's Electronic medical records (EMR), inpatient Hospitalisation records and Pharmacy records.

study_start_date_type: Actual

status: Suspended

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceCitation: Romeo, C, P Meeus, M Rodrigues, E Leblanc, A Floquet, P Pautier, F Marchal, et al. " EP967 Natural history of patients with BRCA-mutated high grade epithelial ovarian cancer (HGEOC) before the era of PARP inhibitors maintenance in 1st line treatment ". In ePoster, A513.3-A513. BMJ Publishing Group Ltd, 2019. https://doi.org/10.1136/ijgc-2019-ESGO.1013.

ReferenceCitation: De Nonneville A, Zemmour C, Frank S, Joly F, Ray-Coquard I, Costaz H, Classe JM, Floquet A, De la Motte Rouge T, Colombo PE, Sauterey B, Leblanc E, Pomel C, Marchal F, Barranger E, Savoye AM, Guillemet C, Petit T, Pautier P, Rouzier R, Gladieff L, Simon G, Courtinard C, Sabatier R. Clinicopathological characterization of a real-world multicenter cohort of endometrioid ovarian carcinoma: Analysis of the French national ESME-Unicancer database. Gynecol Oncol. 2021 Oct;163(1):64-71. doi: 10.1016/j.ygyno.2021.07.019. Epub 2021 Jul 19.

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publisher_dissemination: Elsevier

ReferenceCitation: Rodrigues M, Joly F, Ray-Coquard I, Costaz H, Classe JM, Floquet A, De la Motte Rouge T, Colombo PE, Provensal Gross M, Leblac E, Pomel C, Marchal F, Barranger E, Savoye AM, Guillemet C, Petit T, Pautier P, Rouzier R, Courtinard C, Gladieff L. Real-world clinical outcomes of patients with de novo advanced high-grade epithelial ovarian cancer eligible to niraparib maintenance in France. ESMO Congress, September 16-21, 2021 [ePoster 746P] DOI:https://doi.org/10.1016/j.annonc.2021.08.1188

doi: rodrigues

ReferenceCitation: Thomas QD, Boussere A, Classe JM, Pomel C, Costaz H, Rodrigues M, Ray-Coquard I, Gladieff L, Rouzier R, Rouge TM, Gouy S, Barranger E, Sabatier R, Floquet A, Marchal F, Guillemet C, Polivka V, Martin AL, Colombo PE, Fiteni F. Optimal timing of interval debulking surgery for advanced epithelial ovarian cancer: A retrospective study from the ESME national cohort. Gynecol Oncol. 2022 Oct;167(1):11-21. doi: 10.1016/j.ygyno.2022.08.005. Epub 2022 Aug 13.

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

ReferenceCitation: Bini M, Quesada S, Meeus P, Rodrigues M, Leblanc E, Floquet A, Pautier P, Marchal F, Provansal M, Campion L, Causeret S, Gourgou S, Ray-Coquard I, Classe JM, Pomel C, De La Motte Rouge T, Barranger E, Savoye AM, Guillemet C, Gladieff L, Demarchi M, Rouzier R, Courtinard C, Romeo C, Joly F. Real-World Data on Newly Diagnosed BRCA-Mutated High-Grade Epithelial Ovarian Cancers: The French National Multicenter ESME Database. Cancers (Basel). 2022 Aug 21;14(16):4040. doi: 10.3390/cancers14164040.

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repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: MDPI

ReferenceCitation: Brouillard-Saby F, Saint-Martin C, Ray-Coquard I, Gladieff L, Pomel C, Colombo PE, Classe JM, Chevrier M, Joly F, De la Motte Rouge T, Floquet A, Sabatier R, Barranger E, Costaz H, Leblanc E, Marchal F, Pautier P, Bosquet L, Rodrigues M. Efficacy of chemotherapy according to BRCA status in patients with high-grade serous ovarian carcinoma at first platinum-sensitive relapse. Int J Gynecol Cancer. 2023 Apr 3;33(4):577-584. doi: 10.1136/ijgc-2022-003993.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: British Medical Journal

ipd_sharing: No

lead_sponsor: UNICANCER

collaborators: AstraZeneca GlaxoSmithKline

sponsor_collaborators: UNICANCER AstraZeneca GlaxoSmithKline

lead_sponsor_type: industriel

status_simplified: Unknown


title: Multicentre and Randomized Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery

acronym: MITRA-HR

summary:
The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® in comparison with a surgical treatment strategy in patients with severe primary mitral regurgitation judged eligible for anatomical repair with the MitraClip® or mitral valve surgery with high surgical risk.

This trial is a French and Monegasque, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years ( clinical visit at 1 month, at 6 months and 12 months, phone call at 18 months and clincial visit at 24 months).

status: Recruiting

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Nantes University Hospital

collaborators:
Ministère de la Santé
Abbott

sponsor_collaborators:
Nantes University Hospital
Ministère de la Santé
Abbott

location_country: Monaco France

location_facility:
Chu Saint Etienne
Chru Brest
Chu Angers
Hopital Prive Le Bois Lille
Institut Mutualiste Montsouris
Hopital Bichat
Chu Rennes
CHU de Rouen
Chu Bordeaux
Chu Nantes
CHU LYON
Centre Chirurgical Marie Lannelongue
Ch Annecy
Hopital Henri Mondor Aphp
Clinique Saint Augustin
Hopital La Pitie Salpetriere
Clinique Du Tonkin
Hopital Civil Strasbourg
Clinique Pasteur
Hopital Rangueil
Clinique Du Millenaire
Centre Cardio-Thoracique de Monaco
Chru Lille
Hopital Prive Clairval
Chu Grenoble
Hopital La Timone
Clinique de La Sauvegarde
Hopital St Joseph
Chu Poitiers
Hopital Europeen Georges Pompidou
Centre Cardiologique Du Nord
Chru Tours
Institut Hospitalier Jacques Cartier

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

type_etablissement: CH

acronyme: MITRA HR

titre: Etude multicentrique randomisée du système de réparation percutané de valve mitrale MITRACLIP® dans la prise en charge des Insuffisances Mitrales primitives chez des patients éligibles à une chirurgie mitrale à Risque élevé

discipline_principale: cardiologie

nom_porteur: GUÉRIN

prenom_porteur: Patrice


title: Inhaled Versus Intravenous Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department

acronym: CLIN-AEROMORPH

summary:
Prospective single-blind, multicenter, national, randomized, controlled trial in 15 Emergency Department to compare two ways of morphine titration. The eligible patient is included immediately after his arrival in the Emergency Department, after being questioned by the triage nurse about the presence and the intensity of pain, when the VAS is greater than 70 (or EN>7) and after written consent.

After installation into the examination room, patient is randomized in one of two parallel groups (stratified by sex and center using software) and receives one of the two treatments, either inhaled morphine + IV placebo or IV morphine+ inhaled placebo (control group).

In both groups, titration is defined by a dose of repeated boluses as long as the relief is not achieved (VAS> 30 or EN >3) and the criteria to stop titration are not met.

A 5 minutes time interval between the boluses is chosen. Each aerosol takes 5 minutes at a constant air flow, aerosol mask, plastic tubing and PVC transparent tank are used.

Thus patient receives a maximum of 3 aerosol (one aerosol every 10 minutes) and a maximum of 6 IV injections (one injection every 5 minutes) The stopping criteria, except pain relief, are linked to the occurrence of side effects and specific cares are described into the protocol (in case of severe ventilatory depression naloxone titration is provided). Exit criteria from the emergency room and from the hospital are defined. An information sheet is delivered.

status: Unknown status

ReferenceType: derived

ReferenceCitation: Lvovschi VE, Joly J, Lemaire N, Maignan M, Canavaggio P, Leroi AM, Tavolacci MP, Joly LM. Nebulized versus intravenous morphine titration for the initial treatment of severe acute pain in the emergency department: study protocol for a multicenter, prospective randomized and controlled trial, CLIN-AEROMORPH. Trials. 2019 Apr 11;20(1):209. doi: 10.1186/s13063-019-3326-3.

repository_institution: PubMed Central - Europe PMC

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Rouen

location_facility:
chu de Toulouse
Hôpital Bichat-Claude Bernard
CHU Nice
CHU Hôpitaux BORDEAUX
Hospices civils de Lyon
CHRU de Lille
CH Eure Seine Hôpital d'Evreux
CH Le Mans
La Pitié Salpétrière
CHU Gabriel Montpied
Chu Strasbourg
CHI Robert Ballanger
GH Le Havre
CH Agen-Nérac
Hopital COCHIN
CHU Grenoble
CHU de Caen
Hôpital Lariboisière
CHU-Hôpitaux de Rouen

intervention_type: Drug

region: Normandie

nom_etablissement: CHU ROUEN

acronyme: CLIN AEROMORPH

titre: Evaluation de la titration morphinique par nébulisation dans les douleurs aigues sévères aux urgences

discipline_principale: médecine d'urgence

nom_porteur: LVOVSCHI

prenom_porteur: Virginie


acronym: EWALL-INO

lead_sponsor: Versailles Hospital

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

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

status: Active, not recruiting

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

type: EudraCT Number

source: euctr


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

acronym: EPF

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

time_perspective: Prospective

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

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

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

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

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

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

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

evidence: open (via free pdf)

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

publisher_dissemination: Wolters Kluwer Health

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

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

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

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

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

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

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

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

ReferenceCitation: Warszawski J, Tubiana R, Le Chenadec J, Blanche S, Teglas JP, Dollfus C, Faye A, Burgard M, Rouzioux C, Mandelbrot L; ANRS French Perinatal Cohort. Mother-to-child HIV transmission despite antiretroviral therapy in the ANRS French Perinatal Cohort. AIDS. 2008 Jan 11;22(2):289-99. doi: 10.1097/QAD.0b013e3282f3d63c.

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

location_facility: Centre Hospitalier Général- Hôpital Delafontaine

location_facility: Groupe Hospitalier Cochin Tarnier Port-Royal


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

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

status: Completed

study_completion_date_type: Actual

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

oa_host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Lille

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

unpaywall_oa_status: green

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

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

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

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

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

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

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

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

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

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

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

ReferenceCitation: Warszawski J, Lechenadec J, Faye A, Dollfus C, Firtion G, Meyer L, Douard D, Monpoux F, Tricoire J, Benmebarek Y, Rouzioux C, Blanche S. Long-term nonprogression of HIV infection in children: evaluation of the ANRS prospective French Pediatric Cohort. Clin Infect Dis. 2007 Sep 15;45(6):785-94. doi: 10.1086/521165. Epub 2007 Aug 14.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Institut d'Hématologie et Oncologie Pédiatrique

status_simplified: Completed


acronym: TopNIVO

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

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

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

sponsor_collaborators:
UNICANCER
Bristol-Myers Squibb

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

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


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

acronym: EPO-PRETAR

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

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

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

design_allocation: Non-Randomized

ipd_sharing: Undecided

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Centre Hospitalier Universitaire de STRASBOURG


acronym: PACMAN

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

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

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

evidence: open (via page says license)

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

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

repository_normalized: LillOA (Lille Open Archive)

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

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

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

location_facility: Hôpital Estaing, CHU de Clermont Ferrand

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

titre: Effets perioperatoires de l'administration de corticosteroides sur la morbi-mortalité après une chirurgie majeure.


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

acronym: MGMT-NET

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

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

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

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

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

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital François Mitterrand - CHU Dijon Bourgogne

location_facility: Hôpital Estaing, CHU de Clermont-Ferrand

location_facility: Hôpital Edouard Herriot - Hospices Civils de Lyon


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

acronym: CARADERM

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

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

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

lead_sponsor: University Hospital, Lille

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


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

acronym: THEIA

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

location_facility:
CH métropole Savoie
CH de La Rochelle
Fondation Ophtalmologique Rothschild
CHU de Nice
CHU
CH de Saint Nazaire
CHD Vendée
CHU de Toulouse
CHU de Tours
CHU de Montpellier
CH Vannes
CHU Caen
CHU de Rennes
Ch Perpignan
CHU Rouen
CHU de Nantes
CH Annecy Genevois

acronyme: THEIA

titre: Etude multicentrique randomisée en double aveugle, double placebo de phase III évaluant l'efficacité et la sécurité de la THrombolysE par voie IV (altéplase) dans l'occlusion aiguë de l'Artère centrale de la rétine

discipline_principale: neurologie

nom_porteur: GUILLON

prenom_porteur: Benoit


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

acronym: QDISS

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

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

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

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

evidence: oa repository (via page says license)

repository_normalized: Research Square

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

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


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

acronym: SAMCO

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

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

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

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

ReferenceType: background

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

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility: Chr - Centre Hospitalier Régional de La Source

location_facility: Privé - Cac- Centre Georges-Francois Leclerc

location_facility: Ch - Chic - Centre Hospitalier de Cornouaille

location_facility: Ch - Groupe Hospitalier Intercommunal Le Raincy

location_facility: Ch - Centre Hospitalier Metropole Savoie

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

location_facility: Privé - Institut de Cancerologie de Lorraine

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

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

location_facility: Ch - Centre Hospitalier Docteur Schaffner

location_facility: Chi - Centre Hospitalier de Castres Mazamet

location_facility: Chu - Centre Hospitalier Universitaire Pontchaillou

location_facility: Ch - Centre Hospitalier de Montceau Les Mines

location_facility: Ch - Centre Hospitalier Ardeche Meridionale

location_facility: Ch - Centre Hospitalier Marne La Vallee-Jossigny

location_facility: Privé - Centre de Cancérologie Du Grand Montpellier

location_facility: Ch - Centre Hospitalier de Charleville Mezieres

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

location_facility: Ch - Hopital Louis Pasteur - Oncologie Hematologie

location_facility: Privé - Centre de Radiotherapie Pierre Curie

location_facility: Privé - Institut de Cancerologie de Bourgogne Grrecc


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

acronym: BBQ

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

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

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

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

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

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

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

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

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

lead_sponsor: University Hospital, Brest

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

region: Bretagne

nom_etablissement: CHRU BREST

type_etablissement: CHUR

acronyme: BBQ

titre: Prévention des Fausses Couches Spontanées Répétées par Hydroxychloroquine. Essai thérapeutique multicentrique, randomisé, en double insu, contre placebo.

discipline_principale: gynécologie

nom_porteur: Pasquier

prenom_porteur: Elisabeth


title: Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation

acronym: TRAP

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

lead_sponsor: Rennes University Hospital

location_facility: Chu de Bordeaux - Groupe Hospitalier Sud

location_facility: CHU de DIJON - HOPITAL FRANCOIS MITTERAND

intervention_type: Other


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

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

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

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

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

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

primary_purpose: Prevention

sponsor_collaborators:
University Hospital, Brest
ERCR SPURBO

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


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

acronym: AMIKINHAL

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

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

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

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

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

repositories:
HAL
PubMed Central
univOAK

repositories_concat: HAL;PubMed Central;univOAK

lead_sponsor: University Hospital, Tours

location_facility: Service de Réanimation Médicale - CHU La Milétrie

location_facility: Service de Réanimation Médicale - CH d'Angoulême

location_facility: Service de Réanimation Médicale - CHU Rouen

location_facility: Service de Réanimation médicale, Hôpital Trousseau

location_facility: Service de Réanimation Médicale - CHD Les Oudairies

location_facility: Service de Réanimation Médicale - Hôpital Pitié Salpêtrière

location_facility: Service de Réanimation Médicale - CHU Pontchaillou

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

location_facility: Service de Réanimation Médicale - Hôpital Louis Mourier

location_facility: Service de Réanimation Médicale - Hôpital de Hautepierre

location_facility: Service de Réanimation Médicale - Hôpital Charles Nicolle

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

acronyme: AMIKINHAL

titre: Étude multicentrique randomisée, contrôlée en double aveugle évaluant l'amikacine inhalée dans la prévention de la pneumonie acquise sous ventilation mécanique

discipline_principale: anesthésiologie / réanimation

nom_porteur: EHRMANN

prenom_porteur: Stephan


title: Motivations and Psychological Aspects of the Gametes' Donation

acronym: DonDon

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

ReferenceCitation: Ahuja KK, Mostyn BJ, Simons EG. Egg sharing and egg donation: attitudes of British egg donors and recipients. Hum Reprod. 1997 Dec;12(12):2845-52. doi: 10.1093/humrep/12.12.2845.

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

ReferenceCitation: Pennings G. Mirror gametes donation. J Psychosom Obstet Gynaecol. 2007 Dec;28(4):187-91. doi: 10.1080/01674820701656492.

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

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

lead_sponsor: University Hospital, Toulouse

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


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

acronym: BIGG

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

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


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

acronym: eCOBRA

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

lead_sponsor: CeloNova BioSciences, Inc.

sponsor_collaborators:
CeloNova BioSciences, Inc.
AlpinARC

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


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

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

location_facility: Centre Hospitalier intercommunale Meulan les mureaux

location_facility: Centre Hospitalier de la région d'Annecy


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

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

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

sponsor_collaborators: UNICANCER Pfizer

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

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

location_facility: Centre Hospitalier de Tours - Hopital Bretonneau

location_facility: Centre d'Oncologie radiothérapie de Macon

location_facility: Institut Daniel Hollard - Groupe Hospitalier Mutualiste de Grenoble

location_facility: Centre ONCOGARD - Institut de Cancérologie du Gard

location_facility: CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologi

location_facility: Centre Hospitalier Départemental de Vendée

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

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


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

acronym: ProPILARifax

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

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators:
Alfasigma S.p.A.
LC2 PHARMA

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

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

acronyme: ProPILA rifax

titre: Essai multicentrique, randomisé, en double aveugle, contrôlée versus placebo comparant deux stratégies thérapeutiques dans la prévention primaire de l'infection spontanée du liquide d'ascite chez le patient cirrhotique sévère: utilisation ou non de la rifaximine

discipline_principale: hépatologie

nom_porteur: THEVENOT

prenom_porteur: Thierry


lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

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

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

repository_institution: PubMed Central - Europe PMC

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

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


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

acronym: VIGI-MESH

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

lead_sponsor: Poitiers University Hospital

collaborators: Agence Nationale de sécurité du Médicament

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

intervention_type: Procedure


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

acronym: AlcalUN

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

publisher_dissemination: Wiley

lead_sponsor: Jean-Philippe Bertocchio

location_facility: La Conception University Hospital, AP-HM

location_facility: Institut Phocéen de Néphrologie, Clinique Bouchard

location_facility: Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu

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


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

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

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

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

lead_sponsor: Jazz Pharmaceuticals

location_country:
Italy
Portugal
United Kingdom
France

location_facility: Great Ormond Street Hospital Children's Charity

location_facility: Ospedale Ca' Granda Ospedale Maggiore di Milano

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

location_facility: CHU Bordeaux Groupe hospitalier Pellegrin Enfants

location_facility: Clinica Ematologica-Azienda Ospedaliero Universitaria

location_facility: UO Oncoematologia Ospedale Pediatrico Mayer

location_facility: Istituto per l'Infanzia IRCCS Burlo Garofolo


acronym: IONESCO

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

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

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

sponsor_collaborators: Intergroupe Francophone de Cancerologie Thoracique

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

status: Terminated

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


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

acronym: PAP

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

primary_purpose: Supportive Care

lead_sponsor: Pierre Fabre Dermo Cosmetique

location_country: Spain France

location_facility: Centre Hospitalier de Dunkerque - Service de Dermatologie

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

location_facility: GHRMSA Hôpital Emile Muller Service de Dermatologie

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

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

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

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

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


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

acronym: LEA

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

lead_sponsor: AbbVie

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

location_facility: Centre Hospitalier Universitai /ID# 155465

location_facility: Charles Nicolle Hosp chu rouen /ID# 158688

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

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 154620

location_facility: Charles Nicolle Hosp chu rouen /ID# 152670


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

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

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

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

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

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

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

lead_sponsor: Institut Curie

sponsor_collaborators:
Institut Curie
UNICANCER

location_facility: CHRU Montpellier - Hôpital A. de Villeneuve

location_facility: NANCY Institut de Cancérologie de Lorraine


acronym: ULTIMATE

lead_sponsor: UNICANCER

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

sponsor_collaborators:
UNICANCER
Breast International Group

location_facility: Institut Daniel Hollard Groupe Hôspitalier

location_facility: Hospital Clínico Universitario de Valencia

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

type: Other Identifier

location_country: Spain Sweden France