RECRUITINGOBSERVATIONAL
Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype
Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype - A Prospective Observational Study
About This Trial
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 May Be Eligible (Plain English)
Patients are eligible to be included in the study, if all the following inclusion criteria are met:
- Patients with newly diagnosed diagnosed by tissue sample (biopsy-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 willing to sign a consent form, which includes compliance with the requirements and restrictions listed in the willing to sign a consent form 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
OTHER
Standard of care
Patients receive standard of care treatment according to local and national guidelines
Locations (1)
Rigshospitalet
København Ø, Region Sjælland, Denmark