Prognostic and Predictive Biomarkers in Ovarian Cancers

NCT03010124 | Recruiting

• 2 other identifiers: 2015-A01183-462015/2290
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  up to 12 months

  Correlation of baseline biomarkers with PFS will occur at 12 months following last patient inclusion

Study Arms (1)

Patients with ovarian cancer

OTHER

Procedure: Blood sample

Interventions

Blood sample PROCEDURE

Patients with ovarian cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New patient with a diagnosis of OC, or
• 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
• 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.
• Signed informed consent
• Age ≥ 18
• Patient affiliated to a social security regimen or beneficiary of the same

You may not qualify if:

• Coagulation abnormalities that contra-indicates the biopsy

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Alexandra LEARY, MD

CONTACT

+33 (0)1 42 11 43 89; alexandra.leary@gustaveroussy.fr

Damien DRUBAY

CONTACT

+33 (0)1 42 11 42 11; damien.drubay@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: January 4, 2017
• Study Start: September 26, 2016
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2032
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)