Clinical trial NCT03976999: Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers
Official title: Development of a Prospective and Monocentric Cinical and Biological Database in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primitive Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Keywords: Biological Specimen Banks
Cancer
Gynecology
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of patients who gave their consent to participate in the study
timeFrame: Until the study completion : 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: ICM - Institut régional du Cancer Montpellier
Study officials:
affiliation: ICM - Institut régional du Cancer Montpellier
name: COLOMBO Pierre-Emmanuel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.