BOVARY CE: Using Liquid Biopsy in Newly Diagnosed Patients With High Grade Adenocarcinoma of Ovarian Origin, Fallopian Tubes or Primary Peritoneal

Sponsor

Institut de Cancérologie de Lorraine (Other)

Overall Status

Recruiting

CT.gov ID

NCT04511988

Collaborator

(none)

Enrollment

Location

Arm

47.5

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Other: Diagnostic Test	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Jul 17, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental blood sample (20 ml) and biopsy	Other: Diagnostic Test blood sample (20 ml) and biopsy

Arm

Intervention/Treatment

Experimental: Experimental

blood sample (20 ml) and biopsy

Other: Diagnostic Test

blood sample (20 ml) and biopsy

Outcome Measures

Primary Outcome Measures

Using the concentration of cfDNA to predict disease events [12 months]
cfDNA concentration (ng / µl)

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 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

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: LEUFFLEN Léa, MD PhD, Institut de Cancérologie de Lorraine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut de Cancérologie de Lorraine

ClinicalTrials.gov Identifier:

NCT04511988

Other Study ID Numbers:

2020-A02251-38

First Posted:

Aug 13, 2020

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma

Study Results

No Results Posted as of Mar 31, 2022