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

NCT03881683 | Completed

• 1 other identifier: 2018-A03113-52
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

BRCA 1/2 genes; Circulating Tumor DNA/blood*; somatic tumor mutations; HRD genes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (1)

HRD and BRCA mutations

EXPERIMENTAL

Diagnostic Test: HRD and BRCA mutations

Interventions

HRD and BRCA mutations DIAGNOSTIC_TEST

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

HRD and BRCA mutations

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54506, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• GAVOILLE CELINE, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

• HARLE ALEXANDRE, PhD pharmaD

  Institut de Cancérologie de Lorraine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 19, 2019
• Study Start: February 21, 2020
• Primary Completion: February 19, 2021
• Study Completion: February 19, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

FR (1)