Prognostic and Predictive Biomarkers in Ovarian Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Blood sample
Primary outcome measures
- Progression Free Survival [Time frame: Correlation of baseline biomarkers with PFS will occur at 12 months following last patient inclusion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Gustave Roussy — Villejuif
Publications
- Kfoury M, Bonnet C, Delanoy N, Howarth K, Marzac C, Rouleau E, Micol JB, Leary A. Dynamic changes in TP53 mutated circulating tumor DNA predicts outcome of patients with high-grade ovarian carcinomas. Int J Gynecol Cancer. 2024 Nov 4;34(11):1836-1839. doi: 10.1136/ijgc-2024-005581. PMID 39313297
Identifiers
NCT: NCT03010124 · 2015-A01183-46 · 2015/2290