Characterizing ovarian cancer patients based on genetic factors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to analyze a large cohort of patients with epithelial ovarian cancer who are receiving standard care treatment. It focuses on the distribution of patients based on their BRCA1/2 and homologous recombination deficiency (HRD) status. The study is divided into two observational periods: the first assesses patient responses to first-line chemotherapy, while the second characterizes long-term and short-term responders over a maximum of 36 months. Clinical samples will also be collected for further analysis.

Why it matters

Who can join: the full rules

Patients are eligible to be included in the study, if all the following inclusion criteria are met:

* Patients with newly diagnosed histologically confirmed epithelial ovarian cancer:

  * FIGO stage I-II with a known BRCA1/2 mutation (germline/gBRCA or somatic/tBRCA)
  * FIGO stage III-IV of any histology
* Women aged ≥18 years of age at the time of diagnosis
* Patients intended for platinum-based chemotherapy treatment
* Patients capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
* Patients consent to provide archival tumor tissue sample

Patients are ineligible to be included in the study, if any of the exclusion criteria are met:

* Non-epithelial ovarian cancer, borderline tumors, or mucinous histology
* Patients with FIGO stage I-II, BRCAwt ovarian cancer

Where it's running

• Rigshospitalet
  København Ø, Region Sjælland, Denmark Recruiting

Study contacts

• Study coordinator: Kristine Madsen, MD
• Email: kristine.madsen.01@regionh.dk
• Phone: 004535453311

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.