Clinical trial · Observational
Upfront Systematic Tumour BRCA Testing in Patients With High Grade Serous or Endometrioid Ovarian, Fallopian Tube or Primary Peritoneal Cancer (HGSEC): The t-BRCA Study
Upfront Systematic Tumour BRCA Testing in Patients With High Grade Serous or Endometrioid Ovarian, Fallopian Tube or Primary Peritoneal Cancer: The t-BRCA Study
NCT06274541CI-TRIAL-00107890completedClinicalTrials.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)
A pilot study to evaluate the feasibility of a NGS-based tumour BRCA1/2 mutation testing pathway initiated in the oncology clinic for patients with HGSEC, either at primary diagnosis or first relapse, whereby only patients with a positive germline BRCA1/2 mutation test will be referred to clinical genetics.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrioid Carcinoma Ovary | — | UNRESOLVED | — |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Serous Ovarian Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Somatic and Germline BRCA1/2 Testing | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with HGSEC
- interventionNames
- Genetic: Somatic and Germline BRCA1/2 Testing
Primary outcomes (5)
- measure
- Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of clinicians' experience.
- timeFrame
- 24 months
- description
- The primary outcome measure is to assess the feasibility and potential resource impact of the initiation of an ovarian cancer tumour tissue BRCA1/2 mutation testing pathway in the oncology clinic. This will be assessed in terms of clinicians' and patients' experience, impact on patient management and health economic analysis is the primary outcome measure. The primary outcome measure will be assessed via Clinician and patient questionnaires which will evaluate satisfaction/experience with tBRCA testing pathway.
- measure
- Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of patients' experience.
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with high grade serous or high grade endometrioid ovarian, fallopian tube or primary peritoneal carcinoma who: Are newly diagnosed FIGO stage I - IV or Are currently undergoing primary chemotherapy +/- surgery or Are in remission after completing primary treatment for FIGO stage I - IV disease or Are being planned for, are undergoing or have completed treatment for first relapse 2. Patients with available tumour tissue (archival FFPE surgical resection or tissue/peritoneal biopsy) obtained prior to chemotherapy delivery, for tumour BRCA1/2 testing 3. Patients able to give signed and written informed consent 4. Patients aged 18 years and above Exclusion Criteria: 1. Patients with non-high grade serous or non-high grade endometrioid ovarian, fallopian tube or primary peritoneal carcinoma or unclear histology 2. Patients in second or later relapse of their disease 3. Patients who are known BRCA1 or BRCA2 mutation carriers 4. Patients who have been previously tested for germline BRCA1/2 mutations or have been tested with a hereditary cancer gene panel.
References
Publications (0)
Data not yet available
No reference posted for this study.