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

February 24, 2026 updated by: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The overall objective of the study is to demonstrate the distribution of ovarian cancer (refers collectively to ovarian, tubal, and peritoneal cancer) by homologous recombination deficiency (HRD) and breast cancer susceptibility gene 1 and 2 (BRCA1/2) mutational status (both germline/gBRCA and somatic/tBRCA is recommended), and further characterize sub-cohorts of long- and short-term responders by identifying clinical and/or molecular markers. Additionally, the translational objective is to collect representative clinical samples for further translational analyses to identify prognostic and/or predictive biomarkers of treatment response/resistance.

The overall objective is separate for each of 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 visit following first line (1L) chemotherapy, to progression or to death, whichever occurs first.
  • OP2: From date of first response assessment visit following 1L chemotherapy to 60 months after first response assessment visit following 1L chemotherapy, to death or to withdrawal of consent, whichever occurs first.

Objective for Observational Period 1 (OP1) is to demonstrate the distribution of ovarian cancer patients with FIGO (International Federation of Gynecology and Obstetrics) stage I-II Breast Cancer Susceptibility Gene 1 and 2 mutations (BRCA1/2mut) ovarian cancer, or stage IIIIV ovarian cancer in cohorts of BRCA1/2, HRD (either BRCA1/2 mutation and/or genomic instability), homologous recombination proficient (HRP) and homologous recombination (HR)- unknown patients.

Objective for Observational Period 2 (OP2) is to further characterize sub-cohorts of short-term responders (progressing < 6 months following maintenance treatment) and long-term responders (progressing ≥ 36 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 1000 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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Newly diagnosed epithelial ovarian cancer patients (FIGO stage I-II with known BRCA1/2 mutation and FIGO stage III-IV of any histology), who are intended for 1L chemotherapy, will be recruited from specialist care centers across Denmark, Finland, Norway, and Sweden. In total 1000 patients will be enrolled applying competitive enrollment. Each patient must meet all the inclusion criteria and none of the exclusion criteria to be included in the study. Under no circumstances can there be exceptions to this rule. Patients who do not meet the entry requirements are screen failures.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ovarian cancer patients
Newly diagnosed patients with ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Other: Standard of care
Patients receive standard of care treatment according to local and national guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endpoint OP1
Time Frame: 60 months
Frequency of surgical resection
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endpoints OP1 - 1.1
Time Frame: 60 months
- First line anti-cancer treatment including outcome
60 months
Endpoints OP1 - 1.2
Time Frame: 60 months
- +/- Residual disease following Primary Cytoreductive Surgery (P-CRS)
60 months
Endpoints OP1 - 1.3
Time Frame: 60 months
- Overall Response Rate (ORR)
60 months
Endpoints OP1 - 1.4
Time Frame: 60 months
- BRCA1/2 and HRD status
60 months
Endpoint OP2 - 2.1
Time Frame: 60 months
- Number of patients receiving maintenance treatment or not
60 months
Endpoint OP2 - 2.2
Time Frame: 60 months
- Progression-Free-Survival (PFS) at 6, 12, 24, 36, 48,and 60 months
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Investigators

  • Study Chair: Mansoor R Mirza, MD, NSGO-CTU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

July 1, 2032

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 7, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSGO-CTU-HERO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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