CompletedNot Applicable

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

Ireland200 participantsStarted 2019-03-22

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with high grade serous or high grade endometrioid ovarian, fallopian tube or primary peritoneal carcinoma who:
✓. Patients with available tumour tissue (archival FFPE surgical resection or tissue/peritoneal biopsy) obtained prior to chemotherapy delivery, for tumour BRCA1/2 testing
✓. Patients able to give signed and written informed consent
✓. Patients aged 18 years and above

Exclusion criteria

✕. Patients with non-high grade serous or non-high grade endometrioid ovarian, fallopian tube or primary peritoneal carcinoma or unclear histology
✕. Patients in second or later relapse of their disease
✕. Patients who are known BRCA1 or BRCA2 mutation carriers
✕. Patients who have been previously tested for germline BRCA1/2 mutations or have been tested with a hereditary cancer gene panel.

What they're measuring

Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of clinicians' experience.

Timeframe: 24 months

Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of patients' experience.

Timeframe: 24 months

The impact on patient management by determining changes in patient treatment (use of a PARP inhibitor or enrolment in BRCA-targeted clinical trials).

Timeframe: 24 months

The impact on patient management by use of clinical genetics counselling sessions.

Timeframe: 24 months

The economic impact of implementing an upfront tumour BRCA1/2 mutation testing pathway in the oncology clinic for HGSEC on the Irish healthcare system, using a health economic analysis (decision analysis model)

Timeframe: 24 months

Trial details

NCT IDNCT06274541

SponsorCancer Trials Ireland

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2025-12-17

View on ClinicalTrials.gov More Serous Ovarian Tumor trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients with high grade serous or high grade endometrioid ovarian, fallopian tube or primary peritoneal carcinoma who:
✓. Patients with available tumour tissue (archival FFPE surgical resection or tissue/peritoneal biopsy) obtained prior to chemotherapy delivery, for tumour BRCA1/2 testing
✓. Patients able to give signed and written informed consent
✓. Patients aged 18 years and above

Exclusion criteria

✕. Patients with non-high grade serous or non-high grade endometrioid ovarian, fallopian tube or primary peritoneal carcinoma or unclear histology
✕. Patients in second or later relapse of their disease
✕. Patients who are known BRCA1 or BRCA2 mutation carriers
✕. Patients who have been previously tested for germline BRCA1/2 mutations or have been tested with a hereditary cancer gene panel.

What they're measuring

Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of clinicians' experience.

Timeframe: 24 months

Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of patients' experience.

Timeframe: 24 months

The impact on patient management by determining changes in patient treatment (use of a PARP inhibitor or enrolment in BRCA-targeted clinical trials).

Timeframe: 24 months

The impact on patient management by use of clinical genetics counselling sessions.

Timeframe: 24 months