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

NCT ID: NCT03881683

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-21
• Study Completion Date: 2021-02-19

Brief Summary

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

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

HRD and BRCA mutations

Group Type: EXPERIMENTAL

HRD and BRCA mutations

Intervention Type: DIAGNOSTIC_TEST

Compare BRCA1/2 and HRD genes mutation detected from blood sample (20 ml) and biopsy

Interventions

HRD and BRCA mutations

Compare BRCA1/2 and HRD genes mutation detected from blood sample (20 ml) and biopsy

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GAVOILLE CELINE, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

HARLE ALEXANDRE, PhD pharmaD

Role: STUDY_CHAIR

Institut de Cancérologie de Lorraine

Locations

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

2018-A03113-52

Identifier Type: -

Identifier Source: org_study_id