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

Recruiting

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cancer
• Interventions: Other: Standard of care

• Registration Number: NCT05574673
• Lead Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-10
• Study Start: 2022-12-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24
• Primary Completion: 2028-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ovarian cancer patients	Standard of care	Newly diagnosed patients with ovarian cancer, fallopian tube cancer or primary peritoneal cancer

Primary Outcome Measures

Name	Time	Method
Endpoint OP1	36 months	Frequency of surgical resection

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 København Ø, Sjaelland, Denmark