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

Institut de Cancérologie de Lorraine24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 1 day (samples will be analyzed in batch at the end of inclusions)

Secondary Outcomes

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