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NCT Number: NCT04511988

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic Test

Other

blood sample (20 ml) and biopsy

Primary outcomes

  1. Using the concentration of cfDNA to predict disease events

    Time frame: 12 months

    cfDNA concentration (ng / µl)

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study 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

Acronym: BOVARY CE

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2020
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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