Ovarian cancer, ovarian carcinoma
Conditions
Interventions
 
From around 778 patients with suspicion of ovarian cancer, we will collect two additional tissue samples. These are collected simultaneously with the routine diagnostic biopsy as part of the clinical
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For biopsy: - Women with suspected EOC, aged 18 years or older who give informed consent for routine diagnostics including the sample for the HRD tests. In a subpopulation we will compare HRD tests on tissue obtained at interval CRS as well. - Written informed consent For Follow-up PARP-i: - Patients with FIGO Stage III and IV EOC cancer who received standard of care with debulking surgery and platinum based chemotherapy and are eligible for PARP-i according to at least one positive HRD test. - Patients with germline or somatic BRCA1/2 pathogenic variants in the tumor will be asked to participate as (positive) controls - Patients without BRCA1/2 pathogenic variant or HRD: only registration of PFS, QOL and OS. Control group: - Included in the PlaComOv study (MEC-2017-500/NL62035.078.17) and given informed consent for the use of data for future research.
Exclusion criteria
Exclusion criteria: - Impossibility to obtain HRD test - Other diagnosis than epithelial ovarian cancer - Mucinous, low grade serous or clear cell type ovarian cancer - Ineligibility for PARP-i treatment: such as (but not exclusive) o Not reached at least partial response to treatment o FIGO stage I-II disease o All HRD tests negative and no BRCA 1/2 carrier - Patients who are not able to understand/sign the Informed Consent. - Known germline BRCA1/2 mutation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS), defined as time from start PARP-i until progression of disease or death from any cause, whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 year and 3-year PFS, overall survival, grade 3-4 hematological toxicity or grade >= 2 non-hematological toxicity leading to dose reduction or clinically significant interruption (>2weeks) or stop PARP-i , time to subsequent therapy, QoL and costs. We will collect blood and plasma samples during this research (opt-in) to study whether we are able to identify ct-DNA and to examine whether we are able to detect HRD using ct-DNA analysis. Some of the inclusion centers use other genomic tests to diagnose BRCA1/2 in the tumor-first project (KWF 12732). We will compare the data of these tests with the HRD tests of the SOPI study in an exploratory analysis. The Hartwig Medical Foundation will perform a WGS of all ovarian cancer patients who are included in the SOPI study. We will use and compare the WGS test with the results of our 3 tests. | — |
Countries
Netherlands
Contacts
Public ContactH.J. Beekhuizen
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed