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

NCT06274541 | Completed

• 1 other identifier: CTRIAL-IE 18-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Serous Ovarian Tumor; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Endometrioid Carcinoma Ovary

Outcome Measures

Primary Outcomes (5)

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

  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.

  24 months

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

  The feasibility will be assessed via Patient experience questionnaires. The patient experience questionnaires will evaluate patients' understanding of tBRCA testing, satisfaction/experience with tBRCA testing pathway, and feedback on the tBRCA testing pathway.

  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).

  A quantifiable outcome measure cannot be added here. The result of the BRCA testing impacts on the treatment decisions which the clinicians makes for the patient.

  24 months

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

  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)

  A decision analysis model will be created to compare the costs and benefits of three BRCA1/2 mutation testing strategies for patients with HGSEC. Health benefit will be measured in quality adjusted life years (QALYs). Costs in the model will include genetic counselling, genetic tests, breast cancer screening, risk reducing surgeries (RRS), palliative care and cancer treatment for patients and their first and second-degree relatives. QALYs will be calculated per individual and aggregated to provide an incremental cost-effectiveness ratio (ICER).

  24 months

Secondary Outcomes (8)

• The proportion of germline and somatic BRCA1 and BRCA2 mutations among patients with HGSEC in Ireland

  78 months

• Patient and disease characteristics (age, stage, degree of surgical cytoreduction, platinum sensitivity) associated with BRCA1/2 mutated HGSEC compared to BRCA1/2 wild type disease.

  78 months

• Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining number of systemic therapies used.

  78 months

• Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining use of PARP inhibitor therapy.

  78 months

• Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining enrolment in clinical trials

  78 months

Study Arms (1)

Patients with HGSEC

Genetic: Somatic and Germline BRCA1/2 Testing

Interventions

Somatic and Germline BRCA1/2 Testing GENETIC

Germline BRCA1/2 mutation testing will be undertaken by NGS using blood samples. Somatic BRCA1/2 mutation testing will be undertaken by NGS using tumour tissue.

Patients with HGSEC

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with high grade serous or endometrioid ovarian, fallopian tube or primary peritoneal cancer (HGSEC), either at primary diagnosis or first relapse.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (5)

Mater Misericordiae University Hospital / Mater Private Hospital

Dublin, Leinster, Ireland

Location

St James's Hospital

Dublin, Leinster, Ireland

Location

Bon Secours

Cork, Munster, Ireland

Location

Cork University Hospital

Cork, Munster, Ireland

Location

University Hospital Limerick

Limerick, Munster, Ireland

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms

Interventions

Diploidy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Ploidies; Genetic Phenomena

Study Officials

• Prof. Bryan Hennessy

  Beaumont Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: February 23, 2024
• Study Start: March 22, 2019
• Primary Completion: December 17, 2025
• Study Completion: March 12, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IE (5)