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

Sponsor

Institut de Cancérologie de Lorraine (Other)

Overall Status

Completed

CT.gov ID

NCT03881683

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Diagnostic Test: HRD and BRCA mutations	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 21, 2020

Actual Primary Completion Date :

Feb 19, 2021

Actual Study Completion Date :

Feb 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HRD and BRCA mutations	Diagnostic Test: HRD and BRCA mutations Compare BRCA1/2 and HRD genes mutation detected from blood sample (20 ml) and biopsy

Arm

Intervention/Treatment

Experimental: HRD and BRCA mutations

Diagnostic Test: HRD and BRCA mutations

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

Outcome Measures

Primary Outcome Measures

Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (SNV, indels) [1 day (samples will be analyzed in batch at the end of inclusions)]
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

Secondary Outcome Measures

Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (large rearrangements, LOH, CNV) [1 day (samples will be analyzed in batch at the end of inclusions)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Cancerologie de Lorraine	Vandœuvre-lès-Nancy		France	54506

Sponsors and Collaborators

Institut de Cancérologie de Lorraine

Investigators

Principal Investigator: GAVOILLE CELINE, MD, Institut de Cancérologie de Lorraine
Study Chair: HARLE ALEXANDRE, PhD pharmaD, Institut de Cancérologie de Lorraine