Clinical trial · Observational
Characterizing the Cross-sectional Approach to Investigate the Prevalence of Tissue BRCA1/2 Mutations in Newly Diagnosed Advanced Ovarian Cancer Patients
NCT04222465CI-TRIAL-00054676CHRISTELLEcompletedClinicalTrials.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 multi-center, observational study in Japan. Patients with newly diagnosed FIGO stage III - IV advanced OC will be enrolled sequentially. In this study, data of 200 subjects will be collected at approximately 20 sites in Japan. To reduce regional bias of study sites, the number of enrolled patients per site will be capped
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The prevalence of tBRCAm in the newly diagnosed advanced OC patients
- timeFrame
- Baseline
- description
- For BRCA1 and BRCA2 mutations detected by Myriad myChoice HRD, the number and percentage of patients with the following results will be indicated; deleterious mutation / suspected deleterious / variant of uncertain significance (VUS) / favour polymorphism / no mutation detected
Secondary outcomes (3)
- measure
- The prevalence of gBRCAm in the subjects
- timeFrame
- Baseline
- description
- For BRCA1 and BRCA2 mutations detected by BRACAnalysis, the number and percentage of patients with the following results will be indicated; deleterious mutation / suspected deleterious / variant of uncertain significance (VUS) / favour polymorphism / no mutation detected
- measure
- The prevalence of sBRCAm in the subjects
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 20 years or older of Japanese women at the time of consent (the age of death, in case of dead patient) * Newly diagnosed as advanced OC (FIGO stage III - IV) with epithelial ovarian cancer, primary peritoneal cancer or fallopian-tube cancer \[or a combination of these cancers\] after January 1, 2019 * Patients who have archived formalin-fixed paraffin-embedded (FFPE) samples of primary or peritoneal metastatic tumor collected after January 1, 2019 * Patients who have undergone or are scheduled to undergo BRACAnalysis * Patients who give their written informed consent to participate in this study (However, the cases of death should be handled in accordance with the instructions of the Ethical Review Board of each site.) Exclusion Criteria: * Patients who are not recommended enrolling this study decided by physician
References
Publications (0)
Data not yet available
No reference posted for this study.