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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HRD and BRCA mutations
Sponsored by
Institut de Cancérologie de Lorraine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cancer focused on measuring BRCA 1/2 genes, Circulating Tumor DNA/blood*, somatic tumor mutations, HRD genes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Institut de Cancerologie de Lorraine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HRD and BRCA mutations

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2019
Last Updated
March 29, 2022
Sponsor
Institut de Cancérologie de Lorraine
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1. Study Identification

Unique Protocol Identification Number
NCT03881683
Brief Title
Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer
Acronym
BOVARY Pilot
Official Title
Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 21, 2020 (Actual)
Primary Completion Date
February 19, 2021 (Actual)
Study Completion Date
February 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de Lorraine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
BRCA 1/2 genes, Circulating Tumor DNA/blood*, somatic tumor mutations, HRD genes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HRD and BRCA mutations
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
HRD and BRCA mutations
Intervention Description
Compare BRCA1/2 and HRD genes mutation detected from blood sample (20 ml) and biopsy
Primary Outcome Measure Information:
Title
Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (SNV, indels)
Description
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 Outcome Measure Information:
Title
Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (large rearrangements, LOH, CNV)
Description
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
Time Frame
1 day (samples will be analyzed in batch at the end of inclusions)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GAVOILLE CELINE, MD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HARLE ALEXANDRE, PhD pharmaD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Study Chair
Facility Information:
Facility Name
Institut de Cancerologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54506
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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