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NCT Number: NCT03010124

Prognostic and Predictive Biomarkers in Ovarian Cancers

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.

Recruiting

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Blood sample

Procedure

Primary outcomes

  1. Progression Free Survival

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

    up to 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra LEARY, MD

CONTACT

[email protected]

+33 (0)1 42 11 43 89

Damien DRUBAY

CONTACT

[email protected]

+33 (0)1 42 11 42 11

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: OvBIOMark

Important dates

Study start
2016
Primary completion
2030
Study completion
2032
First posted
Jan 4, 2017
Registry last updated
Mar 20, 2026

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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