Back to resultsPrognostic and Predictive Biomarkers in Ovarian Cancers (OvBIOMark)
Primary Purpose
Ovarian Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- New patient with a diagnosis of OC, or
- Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center presenting with progressive disease, and consenting to CT guided biopsy of relapsed disease, or
- Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center scheduled for surgery for relapsed disease.
- Signed informed consent
- Age ≥ 18
- Patient affiliated to a social security regimen or beneficiary of the same
Exclusion Criteria:
- Patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment;
- Coagulation abnormalities that contra-indicates the biopsy
Sites / Locations
- Gustave RoussyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with ovarian cancer
Arm Description
Outcomes
Primary Outcome Measures
Progression Free Survival
up to 12 months
Secondary Outcome Measures
Full Information
NCT ID
NCT03010124
First Posted
December 13, 2016
Last Updated
February 14, 2020
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT03010124
Brief Title
Prognostic and Predictive Biomarkers in Ovarian Cancers
Acronym
OvBIOMark
Official Title
Prognostic and Predictive Biomarkers in Ovarian Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 26, 2016 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators therefore propose to conduct a biological study of prospectively collected patient tumour samples, ascites, blood and other residual samples (feces, urine, cervical smear) throughout the disease course where markers (at diagnosis and their change with treatment) will be correlated to outcome in order to investigate how genetic diversity in OC prior to treatment and adaptation following treatment contribute to chemotherapy resistance. In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex vivo DNA repair functional assays and isolated in primary culture (and established as xenografts) for target validation experiments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with ovarian cancer
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
up to 12 months
Time Frame
Correlation of baseline biomarkers with PFS will occur at 12 months following last patient inclusion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New patient with a diagnosis of OC, or
Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center presenting with progressive disease, and consenting to CT guided biopsy of relapsed disease, or
Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center scheduled for surgery for relapsed disease.
Signed informed consent
Age ≥ 18
Patient affiliated to a social security regimen or beneficiary of the same
Exclusion Criteria:
Patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment;
Coagulation abnormalities that contra-indicates the biopsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra LEARY, MD
Phone
0142114389
Ext
+33
Email
alexandra.leary@gustaveroussy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Ariane DUNANT
Phone
0142114211
Ext
+33
Email
ariane.dunant@gustaveroussy.fr
Facility Information:
Facility Name
Gustave Roussy
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra LEARY, MD
Phone
0142114389
Ext
+33
Email
alexandra.leary@gustaveroussy.fr
First Name & Middle Initial & Last Name & Degree
Ariane DUNANT
Phone
0142114211
Ext
+33
Email
ariane.dunant@gustaveroussy.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prognostic and Predictive Biomarkers in Ovarian Cancers
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