Serous Ovarian TumorNCT06274541
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
An observational study of Serous Ovarian Tumor and Endometrioid Carcinoma Ovary, run by Cancer Trials Ireland at 5 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Serous Ovarian Tumor, Endometrioid Carcinoma Ovary, Fallopian Tube Cancer
- What is being tested?
- Somatic and Germline BRCA1/2 Testing
- How many people
- 200 participants
- Where
- 5 sitesIreland
- Study dates
- 22 Mar 2019to 12 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Ireland5 sites
Bon Secours
Cork, Munster
Cork University Hospital
Cork, Munster
Mater Misericordiae University Hospital / Mater Private Hospital
Dublin, Leinster
St James's Hospital
Dublin, Leinster
University Hospital Limerick
Limerick, Munster
About this study
Official title: Upfront Systematic Tumour BRCA Testing in Patients With High Grade Serous or Endometrioid Ovarian, Fallopian Tube or Primary Peritoneal Cancer: The t-BRCA Study
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.
Read the detailed description
This pilot study will 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. Germline BRCA1 and BRCA2 MLPA will be carried out to ensure accurate detection of BRCA1/2 LGRs. Patients with a high clinical risk of being germline mutation carriers and a negative germline BRCA1/2 mutation test should also be referred to clinical genetics. The investigators believe an upfront tumour testing pathway would be more cost-effective, as it would involve testing all patients for tumour BRCA1/2 mutations, followed by a single site germline test to clarify somatic/germline status of this mutation in approximately 25% of patients. In contrast, an upfront germline testing pathway would involve germline BRCA1/2 testing for all patients, followed by tumour BRCA1/2 tests in those 80 - 82% patients who do not have a germline BRCA1/2 mutation.
Systematic testing of patients in the oncology clinic for tumour BRCA1/2 mutations should not only ensure that all patients who are eligible for and agreeable to testing receive it, but also improve the quality of referrals to the clinical genetics team. Moreover, this approach is likely to significantly improve the identification rate of HGSEC patients with germline BRCA1/2 mutations, with resultant benefits for these patients in terms of cancer treatment and prevention, and their families in terms of opportunities for cancer prevention. The identification of patients with BRCA1/2 mutant HGSEC may facilitate treatment with effective maintenance therapies, or participation in clinical trials targeted at patients with BRCA1/2-mutated HGSEC. The incorporation of a health economics analysis relating to the introduction of this proposed testing pathway will further inform on the feasibility of its adoption into routine clinical practice on study completion. Finally, this study will also report on the currently unknown frequency, characteristics, disease course, and treatment patterns of germline and somatic BRCA1/2 mutations in an Irish population with HGSEC.
- Conditions
- Serous Ovarian Tumor, Endometrioid Carcinoma Ovary, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- Being tested
- Somatic and Germline BRCA1/2 Testing
- Medical subject headings
- Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatic and Germline BRCA1/2 TestingGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with HGSEC | Not described Receives: Genetic: Somatic and Germline BRCA1/2 Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 24 months
The impact on patient management by use of clinical genetics counselling sessions.
Measured: 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).
Measured: 24 months
Secondary outcomes (8)
The proportion of germline and somatic BRCA1 and BRCA2 mutations among patients with HGSEC in Ireland
Descriptive statistics will be calculated to summarize the number of patients with Germline BRCA1/2 mutations, somatic BRCA1/2 mutations and Variants of Unknown Significance (VUS). Counts, ranges and percentages will be used.
Measured: 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.
Measured: 78 months
Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining number of systemic therapies used.
Measured: 78 months
Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining use of PARP inhibitor therapy.
Measured: 78 months
Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining enrolment in clinical trials
Measured: 78 months
Identification of clinical outcomes (response platinum free interval (PFI)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease.
Measured: 78 months
Identification of clinical outcomes (progression free survival (PFS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease.
Measured: 78 months
Identification of clinical outcomes (overall survival (OS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease.
Measured: 78 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start22 Mar 2019
- Primary completion17 Dec 2025
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serous Ovarian TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Prof. Bryan Hennessy, Principal investigator, Beaumont Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274541
- Sponsor's protocol ID
- CTRIAL-IE 18-01
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upfront Systematic Tumour BRCA Testing in Patients With High Grade Serous or Endometrioid Ovarian, Fallopian Tube or Primary Peritoneal Cancer: The t-BRCA Study
- ClinicalTrials.gov ID
- NCT06274541
- Acronym / sponsor ID
- CTRIAL-IE 18-01
- Conditions
- Serous Ovarian Tumor, Endometrioid Carcinoma Ovary, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This pilot study will 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. Germline BRCA1 and BRCA2 MLPA will be carried out to ensure accurate detection of BRCA1/2 LGRs. Patients with a high clinical risk of being germline mutation carriers and a negative germline BRCA1/2 mutation test should also be referred to clinical genetics. The investigators believe an upfront tumour testing pathway would be more cost-effective, as it would involve testing all patients for tumour BRCA1/2 mutations, followed by a single site germline test to clarify somatic/germline status of this mutation in approximately 25% of patients. In contrast, an upfront germline testing pathway would involve germline BRCA1/2 testing for all patients, followed by tumour BRCA1/2 tests in those 80 - 82% patients who do not have a germline BRCA1/2 mutation.
Systematic testing of patients in the oncology clinic for tumour BRCA1/2 mutations should not only ensure that all patients who are eligible for and agreeable to testing receive it, but also improve the quality of referrals to the clinical genetics team. Moreover, this approach is likely to significantly improve the identification rate of HGSEC patients with germline BRCA1/2 mutations, with resultant benefits for these patients in terms of cancer treatment and prevention, and their families in terms of opportunities for cancer prevention. The identification of patients with BRCA1/2 mutant HGSEC may facilitate treatment with effective maintenance therapies, or participation in clinical trials targeted at patients with BRCA1/2-mutated HGSEC. The incorporation of a health economics analysis relating to the introduction of this proposed testing pathway will further inform on the feasibility of its adoption into routine clinical practice on study completion. Finally, this study will also report on the currently unknown frequency, characteristics, disease course, and treatment patterns of germline and somatic BRCA1/2 mutations in an Irish population with HGSEC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HGSEC | – | Genetic: Somatic and Germline BRCA1/2 Testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatic and Germline BRCA1/2 TestingGermline 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. | Genetic | Patients with HGSEC |
Primary outcome
Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of clinicians' experience.
Time frame: 24 months
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.
Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of patients' experience.
Time frame: 24 months
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.
The impact on patient management by determining changes in patient treatment (use of a PARP inhibitor or enrolment in BRCA-targeted clinical trials).
Time frame: 24 months
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.
The impact on patient management by use of clinical genetics counselling sessions.
Time frame: 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)
Time frame: 24 months
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).
8 secondary outcomes
The proportion of germline and somatic BRCA1 and BRCA2 mutations among patients with HGSEC in Ireland
Time frame: 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.
Time frame: 78 months
Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining number of systemic therapies used.
Time frame: 78 months
Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining use of PARP inhibitor therapy.
Time frame: 78 months
Differences in treatment patterns between BRCA1/2 mutated and BRCA1/2 wild type HGSEC by examining enrolment in clinical trials
Time frame: 78 months
Identification of clinical outcomes (response platinum free interval (PFI)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease.
Time frame: 78 months
Identification of clinical outcomes (progression free survival (PFS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease.
Time frame: 78 months
Identification of clinical outcomes (overall survival (OS)) associated with BRCA1/2-mutated HGSEC, as compared to BRCA1/2 wild type disease.
Time frame: 78 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Bryan Hennessy principal investigator
Beaumont Hospital, Ireland
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serous Ovarian Tumor and Endometrioid Carcinoma Ovary, run by Cancer Trials Ireland at 5 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of an upfront BRCA1/2 mutation testing pathway in HGSEC in terms of clinicians' experience. (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.