NCT03010124 Prognostic and Predictive Biomarkers in Ovarian Cancers
| NCT ID | NCT03010124 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2016-09-26 |
| Primary Completion | 2030-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2016-09-26 with a primary completion date of 2030-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, vaginal 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.
Eligibility Criteria
Inclusion Criteria: 1. New patient with a diagnosis of OC, or 2. 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 3. 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. 4. Signed informed consent 5. Age ≥ 18 6. Patient affiliated to a social security regimen or beneficiary of the same Exclusion Criteria: 1. Patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment; 2. Coagulation abnormalities that contra-indicates the biopsy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03010124 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03010124 currently recruiting?
Yes, NCT03010124 is actively recruiting participants. Contact the research team at alexandra.leary@gustaveroussy.fr for enrollment information.
Where is the NCT03010124 trial being conducted?
This trial is being conducted at Villejuif, France.
Who is sponsoring the NCT03010124 clinical trial?
NCT03010124 is sponsored by Gustave Roussy, Cancer Campus, Grand Paris. The trial plans to enroll 350 participants.
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