Back to resultsUsing Liquid Biopsy in Newly Diagnosed Patients With High Grade Adenocarcinoma of Ovarian Origin, Fallopian Tubes or Primary Peritoneal (BOVARY CE)
Primary Purpose
Ovarian Cancer
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diagnostic Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Patient with non-treated high grade serous and endometrioid carcinoma of ovarian, fallopian tube, or primary peritoneal origin proven cytologically or histologically at inclusion and eligible for treatment
- Patient eligible for an upfront surgery or pretherapeutic coelioscopy
- Adequate haemoglobin rate ≥ 9 g/dL
- Patient affiliated to a social security scheme
- Ability to provide written informed consent
Exclusion Criteria:
- Age < 18 years
- Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
- Contraindication to blood samples of 20 mL
- Pregnant or breast-feeding women
- Ongoing treatment for the newly diagnosed cancer or the recurrence
- Other cancers treated within the last 5 years
- 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
Experimental
Arm Description
blood sample (20 ml) and biopsy
Outcomes
Primary Outcome Measures
Using the concentration of cfDNA to predict disease events
cfDNA concentration (ng / µl)
Secondary Outcome Measures
Full Information
NCT ID
NCT04511988
First Posted
August 11, 2020
Last Updated
August 7, 2023
Sponsor
Institut de Cancérologie de Lorraine
1. Study Identification
Unique Protocol Identification Number
NCT04511988
Brief Title
Using Liquid Biopsy in Newly Diagnosed Patients With High Grade Adenocarcinoma of Ovarian Origin, Fallopian Tubes or Primary Peritoneal
Acronym
BOVARY CE
Official Title
Evaluation of Clonal Heterogeneity and Tumor Evolution Using Liquid Biopsy in Newly Diagnosed Patients With High Grade Adenocarcinoma of Ovarian Origin, Fallopian Tubes or Primary Peritoneal
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 17, 2021 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)
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-CE is a monocentric, pilot, longitudinal, real-life study with a total duration of 36 months. The purpose of this study is to assess the feasibility of using liquid biopsy as a substitute for tissue multisampling, in order to describe clonal heterogeneity and tumor evolution in patients with ovarian cancer. The method involves the inclusion of 20 patients with high-grade ovarian adenocarcinoma, fallopian tubes or primary peritoneal origin, not pretreated, newly diagnosed, and eligible for treatment who will participate in the research. These patients will have several samples throughout their treatment for a period of 2 years: blood samples which will be taken at each therapeutic moment of interest.
Tissue samples which will be taken at the time of the diagnostic laparoscopy and at the time of surgery.
The concentration of cfDNA and tumor heterogeneity will be used to predict disease-related events defined as relapse, progression or death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
blood sample (20 ml) and biopsy
Intervention Type
Other
Intervention Name(s)
Diagnostic Test
Intervention Description
blood sample (20 ml) and biopsy
Primary Outcome Measure Information:
Title
Using the concentration of cfDNA to predict disease events
Description
cfDNA concentration (ng / µl)
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Patient with non-treated high grade serous and endometrioid carcinoma of ovarian, fallopian tube, or primary peritoneal origin proven cytologically or histologically at inclusion and eligible for treatment
Patient eligible for an upfront surgery or pretherapeutic coelioscopy
Adequate haemoglobin rate ≥ 9 g/dL
Patient affiliated to a social security scheme
Ability to provide written informed consent
Exclusion Criteria:
Age < 18 years
Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
Contraindication to blood samples of 20 mL
Pregnant or breast-feeding women
Ongoing treatment for the newly diagnosed cancer or the recurrence
Other cancers treated within the last 5 years
Patient under guardianship or curatorship or deprived of liberty
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LEUFFLEN Léa, MD PhD
Organizational Affiliation
Institut de Cancérologie de Lorraine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancerologie de Lorraine
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54506
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Using Liquid Biopsy in Newly Diagnosed Patients With High Grade Adenocarcinoma of Ovarian Origin, Fallopian Tubes or Primary Peritoneal
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