Clinical trial · Observational
Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India
A Non-interventional, Multicentre Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India
- 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 non-interventional, cross-sectional, multicentre, observational study planned to be conducted at 15 sites across all geographical regions of India. The study targets to enrol 240 patients with approximately 16 patients from each site. Written approval of Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) and written informed consent from willing patients will be obtained prior to the start of the study.
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 Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Ovarian Cancer
Primary outcomes (1)
- measure
- BRCA1 or BRCA2 mutation positive status
- timeFrame
- 1 day
- description
- ENIGMA (Evidence-based Network for the Interpretation of Germline Mutant Alleles)
Secondary outcomes (1)
- measure
- Association between histopathological type and BRCA 1/BRCA 2 mutation positive status
- timeFrame
- 1 Day
- description
- Frequency of different histopathological type and BRCA 1/BRCA 2 mutation positive status will be presented.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who provide written informed consent 2. Female ≥ 18 years of age 3. Previously or newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer patients. Exclusion Criteria: 1\. Patient with any medical condition that, in the opinion of the investigator, would interfere with safe completion of the study
References
Publications (0)
Data not yet available