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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04511988
Acronym
BOVARY CE
Enrollment
20
Registered
2020-08-13
Start date
2021-07-17
Completion date
2026-07-31
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

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.

Interventions

OTHERDiagnostic Test

blood sample (20 ml) and biopsy

Sponsors

Institut de Cancérologie de Lorraine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Using the concentration of cfDNA to predict disease events12 monthscfDNA concentration (ng / µl)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026