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

Peritoneal Neoplasms Clinical Trial

— BCBOvaire  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03976999
• Other study ID #: ICM-BDD2016/04
• Secondary ID: 2016-A01041-50
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2017
• Est. completion date: January 2027

Study information

• Verified date: March 2022
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: BLEUSE Jean-Pierre, M.D
• Phone: +33 4 67 61 31 02
• Email: DRCI-icm105[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Neoplasms
• Neoplasms
• Peritoneal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	ICM - Institut régional du Cancer Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (4)

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, Benítez J, García MJ, Neuhausen S, Gail MH, Hartge P, Peock S, Frost D, Evans DG, Eeles R, Godwi — View 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. Epu — View Citation

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. — View 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/ja — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who gave their consent to participate in the study	The proportion of patients who consent to participate in the study among the screened patients	Until the study completion : 3 years