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.
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
Non-epithelial ovarian cancer, borderline tumors, or mucinous histology
Patients with FIGO stage I-II, BRCAwt ovarian cancer
Newly diagnosed epithelial ovarian cancer patients (FIGO stage I-II with known BRCA1/2 mutation and FIGO stage III-IV of any histology), who are intended for 1L chemotherapy, will be recruited from specialist care centers across Denmark, Finland, Norway, and Sweden. In total 1000 patients will be enrolled applying competitive enrollment. Each patient must meet all the inclusion criteria and none of the exclusion criteria to be included in the study. Under no circumstances can there be exceptions to this rule. Patients who do not meet the entry requirements are screen failures.
Other
Prospective
Standard of care
Other interventionPatients receive standard of care treatment according to local and national guidelines
Endpoint OP1
Frequency of surgical resection
Endpoints OP1 - 1.1
\- First line anti-cancer treatment including outcome
Endpoints OP1 - 1.2
\- +/- Residual disease following Primary Cytoreductive Surgery (P-CRS)
Endpoints OP1 - 1.3
\- Overall Response Rate (ORR)
Endpoints OP1 - 1.4
\- BRCA1/2 and HRD status
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DenmarkClick on the lead sponsor to view all of their trials.
