nctId: NCT06274541 id: CTRIAL-IE 18-01 briefTitle: 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 overallStatus: ACTIVE_NOT_RECRUITING date: 2019-03-22 date: 2025-11 date: 2025-11 date: 2024-02-23 date: 2024-02-23 name: Cancer Trials Ireland class: NETWORK briefSummary: 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 conditions: Endometrioid Carcinoma Ovary conditions: Fallopian Tube Cancer conditions: Primary Peritoneal Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ACTUAL name: Somatic and Germline BRCA1/2 Testing measure: Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of clinicians' experience. measure: Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of patients' experience. measure: The impact on patient management by determining changes in patient treatment (use of a PARP inhibitor or enrolment in BRCA-targeted clinical trials). measure: The impact on patient management by use of clinical genetics counselling sessions. measure: 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) measure: The proportion of germline and somatic BRCA1 and BRCA2 mutations among patients with HGSEC in Ireland measure: 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. measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining number of systemic therapies used. measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining use of PARP inhibitor therapy. measure: Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining enrolment in clinical trials measure: Identification of clinical outcomes (response platinum free interval (PFI)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. measure: Identification of clinical outcomes (progression free survival (PFS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. measure: Identification of clinical outcomes (overall survival (OS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mater Misericordiae University Hospital / Mater Private Hospital city: Dublin state: Leinster country: Ireland lat: 53.33306 lon: -6.24889 facility: St James's Hospital city: Dublin state: Leinster country: Ireland lat: 53.33306 lon: -6.24889 facility: Bon Secours city: Cork state: Munster country: Ireland lat: 51.89797 lon: -8.47061 facility: Cork University Hospital city: Cork state: Munster country: Ireland lat: 51.89797 lon: -8.47061 facility: University Hospital Limerick city: Limerick state: Munster country: Ireland lat: 52.66472 lon: -8.62306 hasResults: False