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

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ClinicalTrials.gov Identifier: NCT05574673
Recruitment Status : Recruiting
First Posted : October 10, 2022
Last Update Posted : May 16, 2023
Sponsor:
Information provided by (Responsible Party):
Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Study Description
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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.

Condition or disease Intervention/treatment
Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Other: Standard of care

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 Design
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype - A Prospective Observational Study
Actual Study Start Date : December 1, 2022
Estimated Primary Completion Date : December 1, 2028
Estimated Study Completion Date : December 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Endpoint OP1 [ Time Frame: 36 months ]
    Frequency of surgical resection


Secondary Outcome Measures :
  1. Endpoints OP1 - 1.1 [ Time Frame: 36 months ]
    - First line anti-cancer treatment including outcome

  2. Endpoints OP1 - 1.2 [ Time Frame: 36 months ]
    - +/- Residual disease following Primary Cytoreductive Surgery (P-CRS)

  3. Endpoints OP1 - 1.3 [ Time Frame: 36 months ]
    - Overall Response Rate (ORR)

  4. Endpoints OP1 - 1.4 [ Time Frame: 36 months ]
    - BRCA1/2 and HRD status

  5. Endpoint OP2 - 2.1 [ Time Frame: 36 months ]
    - Number of patients receiving maintenance treatment or not

  6. Endpoint OP2 - 2.2 [ Time Frame: 36 months ]
    - Progression-Free-Survival (PFS) at 6, 12, 24 and 32 months


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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 350 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.
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05574673


Contacts
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Contact: Mansoor R Mirza, MD 004535459624 mansoor.raza.mirza@regionh.dk
Contact: Signe G Frederiksen, MSc 004535453372 signe.gybel.frederiksen@regionh.dk

Locations
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Denmark
Rigshospitalet Recruiting
København Ø, Sjaelland, Denmark, 2100
Contact: Mansoor Raza Mirza    4535459624    mansoor@rh.regionh.dk   
Contact: Kristine Madsen    35453372    kristine.madsen.01@regionh.dk   
Sponsors and Collaborators
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Investigators
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Study Chair: Mansoor R Mirza, MD NSGO-CTU
More Information
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Responsible Party: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
ClinicalTrials.gov Identifier: NCT05574673    
Other Study ID Numbers: NSGO-CTU-HERO
First Posted: October 10, 2022    Key Record Dates
Last Update Posted: May 16, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nordic Society of Gynaecological Oncology - Clinical Trials Unit:
Ovarian cancer, observational study, HRD
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases