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

RECRUITINGSponsored by Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Actively Recruiting
SponsorNordic Society of Gynaecological Oncology - Clinical Trials Unit
Started2022-12-01
Est. completion2028-05-01
Eligibility
Age18 Years – 100 Years
SexFEMALE
View on ClinicalTrials.gov →

NCT05574673

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

Age: 18 Years – 100 YearsSex: FEMALE
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

Conditions4

CancerFallopian Tube CancerOvarian CancerPrimary Peritoneal Cancer

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