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

NCT04511988 | Active Not Recruiting

• 1 other identifier: 2020-A02251-38
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Using the concentration of cfDNA to predict disease events

  cfDNA concentration (ng / µl)

  12 months

Study Arms (1)

Experimental

EXPERIMENTAL

blood sample (20 ml) and biopsy

Other: Diagnostic Test

Interventions

Diagnostic Test OTHER

blood sample (20 ml) and biopsy

Experimental

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 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

You may not qualify if:

• 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

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

• LEUFFLEN Léa, MD PhD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

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: August 11, 2020
• First Posted: August 13, 2020
• Study Start: July 17, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

FR (1)