Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype (HERO)

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Status

Enrolling

Conditions

Primary Peritoneal Cancer

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Other: Standard of care

Study type

Observational

Funder types

Other

Identifiers

NCT05574673

NSGO-CTU-HERO

Details and patient eligibility

About

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.

Full 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.

Enrollment

350 estimated patients

Sex

Female

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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