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