Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype

Launched by NORDIC SOCIETY OF GYNAECOLOGICAL ONCOLOGY - CLINICAL TRIALS UNIT · Oct 7, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at women with epithelial ovarian cancer, which is a type of cancer that starts in the cells on the surface of the ovaries. The study aims to understand how certain genetic factors, specifically related to BRCA1/2 genes and homologous recombination deficiency (HRD), affect the treatment and outcomes for patients receiving standard chemotherapy. The researchers plan to gather information from a large group of women across different countries to see how these factors play a role in their cancer journey.

To be eligible to join this study, participants need to be women aged 18 or older who have been newly diagnosed with epithelial ovarian cancer at specific stages (I-II with known BRCA mutations or III-IV of any type). They should be planning to receive platinum-based chemotherapy, which is a common treatment for this cancer. Participants will need to provide their consent and agree to share a sample of their tumor tissue. This study is currently recruiting, and women who meet the criteria can expect to contribute to important research that could help improve future cancer treatments.

Gender

FEMALE

Eligibility criteria

• 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