Clinical trial · Observational
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
NCT05574673CI-TRIAL-00104282HEROrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ovarian cancer patients
- description
- Newly diagnosed patients with ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- interventionNames
- Other: Standard of care
Primary outcomes (1)
- measure
- Endpoint OP1
- timeFrame
- 60 months
- description
- Frequency of surgical resection
Secondary outcomes (6)
- measure
- Endpoints OP1 - 1.1
- timeFrame
- 60 months
- description
- \- First line anti-cancer treatment including outcome
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.