Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers
BCBOvaire
Development of a Prospective and Monocentric Cinical and Biological Database in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primitive Peritoneal Cancer
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2017
CompletedFirst Submitted
Initial submission to the registry
June 5, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2032
February 12, 2025
February 1, 2025
10 years
June 5, 2019
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Biological collection
EXPERIMENTALFor 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
Interventions
* 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICM - Institut régional du Cancer Montpellier
Montpellier, 34298, France
Related Publications (4)
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: 26742998RESULTBolton 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, Fridley BL, Loud JT, Greene MH, Mai PL, Chetrit A, Lubin F, Hirsh-Yechezkel G, Glendon G, Andrulis IL, Toland AE, Senter L, Gore ME, Gourley C, Michie CO, Song H, Tyrer J, Whittemore AS, McGuire V, Sieh W, Kristoffersson U, Olsson H, Borg A, Levine DA, Steele L, Beattie MS, Chan S, Nussbaum RL, Moysich KB, Gross J, Cass I, Walsh C, Li AJ, Leuchter R, Gordon O, Garcia-Closas M, Gayther SA, Chanock SJ, Antoniou AC, Pharoah PD; EMBRACE; kConFab Investigators; Cancer Genome Atlas Research Network. Association between BRCA1 and BRCA2 mutations and survival in women with invasive epithelial ovarian cancer. JAMA. 2012 Jan 25;307(4):382-90. doi: 10.1001/jama.2012.20.
PMID: 22274685RESULTColombo 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: 24071502RESULTYang 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: 21990299RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
COLOMBO Pierre-Emmanuel, M.D
ICM - Institut régional du Cancer Montpellier
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2019
First Posted
June 6, 2019
Study Start
July 5, 2017
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2032
Last Updated
February 12, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share