Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer

Study Overview
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Brief Summary
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BOVARY-Pilot is a monocentric prospective transversal pilot study with a total duration of 6 months. The purpose of this study is to determine the feasibility of detecting somatic tumor mutations in the blood of patients with ovarian cancer in order to determine whether a blood test can replace a tissue biopsy to prescribe a personalized treatment. The method will consist of a single blood sample during the patient's visit and prior to the establishment of any newly diagnosed cancer treatment. The concordance of somatic mutations (SNV) found in tissue and in cell-free DNA (cfDNA) extracted from blood will then be compared

Official Title
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Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Diagnostic Test: HRD and BRCA mutations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patient with stage III to IV non-treated high grade ovarian cancer or recurrent high grade ovarian cancer Adequate haemoglobin rate ≥ 9 g/dL Patient who can benefit from an additional blood sample of 20ml. The total volume of each sample meets with the indications of the Order in force establishing the list of researches mentioned in 2 ° of Article L. 1121-1 of the Public Health Code. Availability of tumor samples from biopsy or surgery Patient affiliated to a social security scheme Ability to provide written informed consent Exclusion Criteria: Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study Contraindication to a blood sample of 20 mL Pregnant or breast-feeding women Ongoing treatment for the newly diagnosed cancer or the recurrence Patient pre-treated with poly-ADP-ribose-polymérase-1 (PARP) Inhibitors Patient under guardianship or curatorship or deprived of liberty.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRD and BRCA mutations<br> | Diagnostic Test: HRD and BRCA mutations<br>* Compare BRCA1/2 and HRD genes mutation detected from blood sample (20 ml) and biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (SNV, indels) | Number of patients with detected punctual somatic mutations (SNVs and indels of BRCA1/2 and genes involved in HRD) concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma | 1 day (samples will be analyzed in batch at the end of inclusions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (large rearrangements, LOH, CNV) | Number of patients with detected genomic alterations (large rearrangements, LOH and CNV of BRCA1/2 and genes involved in HRD) concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma | 1 day (samples will be analyzed in batch at the end of inclusions) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BRCA 1/2 genes, Circulating Tumor DNA/blood*, somatic tumor mutations, HRD genes