Prognostic and Predictive Biomarkers in Ovarian Cancers (OvBIOMark)

The investigators therefore propose to conduct a biological study of prospectively collected patient tumour samples, ascites, blood and other residual samples (feces, urine, vaginal smear) throughout the disease course where markers (at diagnosis and their change with treatment) will be correlated to outcome in order to investigate how genetic diversity in OC prior to treatment and adaptation following treatment contribute to chemotherapy resistance. In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex vivo DNA repair functional assays and isolated in primary culture (and established as xenografts) for target validation experiments.

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer
• Intervention / Treatment: Procedure: Blood sample

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandra LEARY, MD; Phone Number: +33 (0)1 42 11 43 89; Email: alexandra.leary@gustaveroussy.fr
• Study Contact Backup: Name: Damien DRUBAY; Phone Number: +33 (0)1 42 11 42 11; Email: damien.drubay@gustaveroussy.fr

Study Locations

• France
  • Val de Marne
    • Villejuif, Val de Marne, France, 94805
      • Recruiting
      • Gustave Roussy
      • Contact: Alexandra LEARY, MD; Phone Number: +33 (0)1 42 11 43 89; Email: alexandra.leary@gustaveroussy.fr
      • Contact: Damien DRUBAY; Phone Number: +33 (0)1 42 11 42 11; Email: damien.drubay@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. New patient with a diagnosis of OC, or
2. Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center presenting with progressive disease, and consenting to CT guided biopsy of relapsed disease, or
3. Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center scheduled for surgery for relapsed disease.
4. Signed informed consent
5. Age ≥ 18
6. Patient affiliated to a social security regimen or beneficiary of the same

Exclusion Criteria:

1. Patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment;
2. Coagulation abnormalities that contra-indicates the biopsy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with ovarian cancer	Procedure: Blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	up to 12 months	Correlation of baseline biomarkers with PFS will occur at 12 months following last patient inclusion

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2016
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2032

Study Registration Dates

• First Submitted: December 13, 2016
• First Submitted That Met QC Criteria: January 2, 2017
• First Posted (Estimated): January 4, 2017

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Ovarian Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 2015-A01183-46; 2015/2290 (Other Identifier: CSET number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO