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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype - A Prospective Observational Study

Conditions
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Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer

Intervention / Treatment
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* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ovarian cancer patients<br>Newly diagnosed patients with ovarian cancer, fallopian tube cancer or primary peritoneal cancer | Other: Standard of care<br>* Patients receive standard of care treatment according to local and national guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoint OP1 | Frequency of surgical resection | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoints OP1 - 1.1 | - First line anti-cancer treatment including outcome | 36 months | 
| Endpoints OP1 - 1.2 | - +/- Residual disease following Primary Cytoreductive Surgery (P-CRS) | 36 months | 
| Endpoints OP1 - 1.3 | - Overall Response Rate (ORR) | 36 months | 
| Endpoints OP1 - 1.4 | - BRCA1/2 and HRD status | 36 months | 
| Endpoint OP2 - 2.1 | - Number of patients receiving maintenance treatment or not | 36 months | 
| Endpoint OP2 - 2.2 | - Progression-Free-Survival (PFS) at 6, 12, 24 and 32 months | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian cancer, observational study, HRD