Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype
NCT ID: NCT05574673
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
350 participants
OBSERVATIONAL
2022-12-01
2028-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Ovarian cancer patients
Newly diagnosed patients with ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Standard of care
Patients receive standard of care treatment according to local and national guidelines
Interventions
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Standard of care
Patients receive standard of care treatment according to local and national guidelines
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patients with FIGO stage I-II, BRCAwt ovarian cancer
18 Years
100 Years
FEMALE
No
Sponsors
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Nordic Society of Gynaecological Oncology - Clinical Trials Unit
OTHER
Responsible Party
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Principal Investigators
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Mansoor R Mirza, MD
Role: STUDY_CHAIR
NSGO-CTU
Locations
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Rigshospitalet
København Ø, Region Sjælland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NSGO-CTU-HERO
Identifier Type: -
Identifier Source: org_study_id
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