Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Pheno… (NCT05574673) | Clinical Trial Compass
RecruitingNot Applicable
Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype
Denmark1,000 participantsStarted 2022-12-01
Plain-language summary
This is a prospective observational multi-country, multi-center study of a large real-world cohort of first line (1L) epithelial ovarian cancer patients, exposed to standard of care (SOC) treatment stratified according to BRCA1/2 and HRD status.
Who can participate
Age range18 Years – 100 Years
SexFEMALE
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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
What they're measuring
1
Endpoint OP1
Timeframe: 60 months
Trial details
NCT IDNCT05574673
SponsorNordic Society of Gynaecological Oncology - Clinical Trials Unit