Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers (BCBOvaire)
Primary Purpose
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Peritoneal Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological collection
Sponsored by
About this trial
This is an interventional other trial for Carcinoma, Ovarian Epithelial focused on measuring Biological Specimen Banks, Cancer, Gynecology
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
Sites / Locations
- ICM - Institut régional du Cancer MontpellierRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biological collection
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03976999
First Posted
June 5, 2019
Last Updated
March 11, 2022
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT03976999
Brief Title
Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers
Acronym
BCBOvaire
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Peritoneal Neoplasms
Keywords
Biological Specimen Banks, Cancer, Gynecology
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biological collection
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Biological collection
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of patients who gave their consent to participate in the study
Description
The proportion of patients who consent to participate in the study among the screened patients
Time Frame
Until the study completion : 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BLEUSE Jean-Pierre, M.D
Phone
+33 4 67 61 31 02
Email
DRCI-icm105@icm.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
COLOMBO Pierre-Emmanuel, M.D
Organizational Affiliation
ICM - Institut régional du Cancer Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICM - Institut régional du Cancer Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BLEUSE Jean-Pierre, MD
Phone
0467613102
Ext
+33
Email
jean-pierre.bleuse@icm.unicancer.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26742998
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.
Results Reference
result
PubMed Identifier
22274685
Citation
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, 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.
Results Reference
result
PubMed Identifier
24071502
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.
Results Reference
result
PubMed Identifier
21990299
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. Erratum In: JAMA. 2012 Jan 25;307(4):363.
Results Reference
result
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Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers
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