Selecting Ovarian Cancer patients for PARP Inhibitor (SOPI) study

Conditions: ovarian cancer
Ovarian carcinoma
10038594
10033283

Registration Number: NL-OMON56928

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 778

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

- 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 neoadjuvant chemotherapy
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 BRAC1/2 mutation

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression Free Survival (PFS), defined as time from start PARP-i until<br /><br>progression of disease or death from any cause, whichever comes first.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1 year and 3-year PFS, overall survival, grade 3-4 hematological toxicity or<br /><br>grade >= 2 non-hematological toxicity leading to dose reduction or clinically<br /><br>significant interruption (>2weeks) or stop PARP-i , time to subsequent therapy,<br /><br>QoL and costs. We will collect blood and plasma samples during this research<br /><br>(opt-in) to study whether we are able to identify ct-DNA and to examine whether<br /><br>we are able to detect HRD using ct-DNA analysis. Some of the inclusion centers<br /><br>use other genomic tests to diagnose BRCA1/2 in the tumor-first project (KWF<br /><br>12732). We will compare the data of these tests with the HRD tests of the SOPI<br /><br>study in an exploratory analysis. The Hartwig Medical Foundation will perform a<br /><br>WGS of all ovarian cancer patients who are included in the SOPI study. We will<br /><br>use and compare the WGS test with the results of our 3 tests.</p><br>