Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers

Официальное название

Development of a Prospective and Monocentric Cinical and Biological Database in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primitive Peritoneal Cancer

Обзор

A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical datas to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to epithetial ovarian cancer, Fallopian tube cancer and Primitive peritoneal cancer.

Подробное описание

A Clinical and Biological Database is a collection of reliable, prospective and representative datas.

This collection, provided to the scientific community, will help to develope research programs such as :

* Cinicals and biological predictive factors of treatments response * Identification of biological tumoral markers associate with survival * Identification of prognosic factors after recidivism * Diagnostics tests optimisation and follow-up from blood samples ( Circulating Tumor Cells (CTC) ) * Developing strong preclinical models. Those models would be later used to test alternative treatments and would help to identify new biomarkers

Вмешательства

• Другое Biological collection
  * Blood samples collected at different times : Before treatment (T1) , after chemotherapy (T2), after interval surgery (T3) and after cancer reccurence (T4) * Tissue samples (tumor tissue and healthy tissue) collected during the surgery

Первичные конечные точки

• Proportion of patients who gave their consent to participate in the study [Срок оценки: Until the study completion : 3 years]

Критерии участия

Критерии включения

• 18 or older
• Patient at the diagnosis of an epithelial ovarian cancer, or a fallopian tube caner or a primitive peritoneal cancer
• Patient eligible for, at least, one surgery and a chemotherapy
• Patient having given his informed, written and express consent

Критерии исключения

• Patient not affiliated to a social protection scheme
• Pregnant and / or nursing women
• Subject under tutelage, curatorship or safeguard of justice
• Patient whose regular follow-up is impossible for psychological, familial, social or geographical reasons

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• ICM - Institut régional du Cancer Montpellier — Montpellier

Публикации

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7. PMID 26742998
• Bolton KL, Chenevix-Trench G, Goh C, Sadetzki S, Ramus SJ, Karlan BY, Lambrechts D, Despierre E, Barrowdale D, McGuffog L, Healey S, Easton DF, Sinilnikova O, Benitez J, Garcia MJ, Neuhausen S, Gail MH, Hartge P, Peock S, Frost D, Evans DG, Eeles R, Godwin AK, Daly MB, Kwong A, Ma ES, Lazaro C, Blanco I, Montagna M, D'Andrea E, Nicoletto MO, Johnatty SE, Kjaer SK, Jensen A, Hogdall E, Goode EL, Fr PMID 22274685
• Colombo PE, Fabbro M, Theillet C, Bibeau F, Rouanet P, Ray-Coquard I. Sensitivity and resistance to treatment in the primary management of epithelial ovarian cancer. Crit Rev Oncol Hematol. 2014 Feb;89(2):207-16. doi: 10.1016/j.critrevonc.2013.08.017. Epub 2013 Sep 8. PMID 24071502
• Yang D, Khan S, Sun Y, Hess K, Shmulevich I, Sood AK, Zhang W. Association of BRCA1 and BRCA2 mutations with survival, chemotherapy sensitivity, and gene mutator phenotype in patients with ovarian cancer. JAMA. 2011 Oct 12;306(14):1557-65. doi: 10.1001/jama.2011.1456. PMID 21990299

Идентификаторы

NCT: NCT03976999 · ICM-BDD2016/04 · 2016-A01041-50

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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