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

Ovarian Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04511988
• Other study ID #: 2020-A02251-38
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 17, 2021
• Est. completion date: July 2026

Study information

• Verified date: August 2023
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Ovarian Cancer

Intervention

Other:
• Diagnostic Test
blood sample (20 ml) and biopsy

Locations

Country	Name	City	State
France	Institut de Cancerologie de Lorraine	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Using the concentration of cfDNA to predict disease events	cfDNA concentration (ng / µl)	12 months