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

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03976999
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 113.9
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Peritoneal Neoplasms	Other: Biological collection	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Development of a Prospective and Monocentric Cinical and Biological Database in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primitive Peritoneal Cancer
• Actual Study Start Date: Jul 5, 2017
• Anticipated Primary Completion Date: Jan 1, 2027
• Anticipated Study Completion Date: Jan 1, 2027

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Biological collection For all the patients include in the studie : 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 In parallel to this biological collection, standardized clinical data will be entered into a database

Other: 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

Outcome Measures

Primary Outcome Measures

1. Proportion of patients who gave their consent to participate in the study [Until the study completion : 3 years]

   The proportion of patients who consent to participate in the study among the screened patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICM - Institut régional du Cancer Montpellier	Montpellier		France	34298

Sponsors and Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

• Principal Investigator: COLOMBO Pierre-Emmanuel, M.D, ICM - Institut régional du Cancer Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
• ClinicalTrials.gov Identifier: NCT03976999
• Other Study ID Numbers: ICM-BDD2016/04; 2016-A01041-50
• First Posted: Jun 6, 2019
• Last Update Posted: Mar 14, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle: Biological Specimen Banks; Cancer; Gynecology
• Additional relevant MeSH terms: Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Mar 14, 2022