Overview
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.
Description
The overall objective of the study is to demonstrate the distribution of ovarian cancer by HRD and BRCA1/2 mutational status and further characterize sub-cohorts of long- and short-term responders. Additionally, to collect representative clinical samples for further translational analyses.
The overall objective is separated by two distinct observational periods defined as Observational Period 1 (OP1) and Observational Period 2 (OP2):
- OP1: From date of diagnosis to date of first response assessment following 1L chemotherapy, progression or death, whichever occurs first
- OP2: From date of first response assessment following 1L chemotherapy to maximum 36 months following 1L chemotherapy, death or withdrawal of consent, whichever occurs first.
Objective for Observational Period 1 (OP1) The objective for OP1 is to demonstrate the distribution of ovarian cancer patients with FIGO stage I-II BRCA1/2mut ovarian cancer, or stage III-IV ovarian cancer in cohorts of BRCA1/2, HRD (either BRCA1/2 mutation and/or genomic instability), HRP and HR-unknown patients.
Objective for Observational Period 2 (OP2) The objective for OP2 is to further characterize sub-cohorts of short-term responders (progressing < 6 months following maintenance treatment) and long-term responders (progressing ≥ 32 months following maintenance treatment) in real-world cohorts of ovarian cancer patients. For FIGO stage I-II BRCA1/2mut or FIGO stage III-IV defined by HRD status determined by Myriad myChoice® CDx HRD test or non-Myriad local HRD test, and BRCA1/2 status.
A total of 350 patients will be enrolled from hospitals in Denmark, Finland, Norway, and Sweden. Competitive enrollment will be applied.
Eligible patients must have 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 of any histology.
Eligibility
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