Ovarian CancerHERONCT05574673
Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype
An observational study of Ovarian Cancer and Primary Peritoneal Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2022to 1 Jul 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Adult, Older adult
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.
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
København Ø, Region Sjælland, 2100
Mansoor Raza Mirza, 4535459624, mansoor@rh.regionh.dk
Kristine Madsen, 35453372, kristine.madsen.01@regionh.dk
About this study
Official title: 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.
Read the 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.
- Being tested
- Standard of care
- Keywords
- Ovarian cancer, observational study, HRD
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Kenny-Caffey syndrome, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Patients receive standard of care treatment according to local and national guidelines
| Study group | Role | What they receive |
|---|---|---|
| Ovarian cancer patients | Newly diagnosed patients with ovarian cancer, fallopian tube cancer or primary peritoneal cancer Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endpoint OP1
Frequency of surgical resection
Measured: 60 months
Secondary outcomes (6)
Endpoints OP1 - 1.1
- First line anti-cancer treatment including outcome
Measured: 60 months
Endpoints OP1 - 1.2
- +/- Residual disease following Primary Cytoreductive Surgery (P-CRS)
Measured: 60 months
Endpoints OP1 - 1.3
- Overall Response Rate (ORR)
Measured: 60 months
Endpoints OP1 - 1.4
- BRCA1/2 and HRD status
Measured: 60 months
Endpoint OP2 - 2.1
- Number of patients receiving maintenance treatment or not
Measured: 60 months
Endpoint OP2 - 2.2
- Progression-Free-Survival (PFS) at 6, 12, 24, 36, 48,and 60 months
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Dec 2022
- Primary completion1 May 2028 (estimated)
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials Unit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mansoor R Mirza, MD, Study chair, NSGO-CTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574673
- Sponsor's protocol ID
- NSGO-CTU-HERO
- Acronym
- HERO
- Status last verified
- Feb 2026
- First submitted
- 5 Oct 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype - A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05574673
- Acronym / sponsor ID
- HERO / NSGO-CTU-HERO
- Keywords
- Ovarian cancer, observational study, HRD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nordic Society of Gynaecological Oncology - Clinical Trials UnitUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Jul 2032 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer patients | – | Other: Standard of careNewly diagnosed patients with ovarian cancer, fallopian tube cancer or primary peritoneal cancer |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of carePatients receive standard of care treatment according to local and national guidelines | Other | Ovarian cancer patients |
Primary outcome
Endpoint OP1
Time frame: 60 months
Frequency of surgical resection
6 secondary outcomes
Endpoints OP1 - 1.1
Time frame: 60 months
Endpoints OP1 - 1.2
Time frame: 60 months
Endpoints OP1 - 1.3
Time frame: 60 months
Endpoints OP1 - 1.4
Time frame: 60 months
Endpoint OP2 - 2.1
Time frame: 60 months
Endpoint OP2 - 2.2
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mansoor R Mirza, MD study chair
NSGO-CTU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Primary Peritoneal Cancer, run by Nordic Society of Gynaecological Oncology - Clinical Trials Unit at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristine Madsen, MD (004535453311, kristine.madsen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endpoint OP1 (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.