RecruitingNCT05574673

Characterization of Epithelial Ovarian Cancer Patients in Terms of Homologous Recombination Phenotype

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


Sponsor

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Enrollment

1,000 participants

Start Date

Dec 1, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Inclusion Criteria7

  • 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

Exclusion Criteria2

  • Non-epithelial ovarian cancer, borderline tumors, or mucinous histology
  • Patients with FIGO stage I-II, BRCAwt ovarian cancer

Interventions

OTHERStandard of care

Patients receive standard of care treatment according to local and national guidelines


Locations(1)

Rigshospitalet

København Ø, Region Sjælland, Denmark

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NCT05574673


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