Precision Oncology Clinical Diagnostic Study In Primary and Metastatic Breast Cancer (PRISM) (PRISM)

February 16, 2026 updated by: Cancer Trials Ireland
This study aims to provide information about the genomics of your breast cancer which your oncologist can use to enhance the treatment of your disease possibly enabling more targeted and personalised therapy.This study will carry out TruSight Oncology Comprehensive (TSOComprehensive) testing on breast cancer tumour tissue that was collected at the time of your breast cancer diagnosis or during your breast surgery or if you have brain metastasis and you have had a biopsy for this. The TruSight Oncology Comprehensive assay is a next-generation sequencing (NGS) test used to analyse cancer-related genomic changes in patients, offering a comprehensive view of potential mutations and other alterations that can impact treatment decisions. The TruSight Oncology Comprehensive assay is CE-IVD marked for use in Europe, meaning that it complies with the relevant EU regulation, for comprehensive genomic profiling for different types of cancer. It analyses 523 cancer-relevant genes from both DNA and RNA to identify variations. It will also look for changes and mutations which may affect cell growth and stability. By identifying relevant mutations and biomarkers, the assay can help oncologists select the most appropriate treatment strategies with the aim of improving patient outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a pragmatic single-arm diagnostic interventional study. The study will use the Illumine TruSight Oncology 500 assay for research use only under Article 5(5) in-house exemption of the EU IVDR (EU 2017/746). Testing will be performed on paraffin embedded tumour tissue. This assay will target 523 genes to assess all somatic DNA variants as well as microsatellite instability (MSI), tumour mutational burden (TMB), and homologous recombination deficiency (HRD). Testing will be performed centrally in the molecular diagnostics laboratory (ISO 15189 accredited) at Beaumont hospital on the Next Seq 550Dx. This lab currently uses this platform for diagnostic comprehensive genomic profiling. Bioinformatic analysis will be undertaken to identify clinically actionable mutations. Results will be discussed at the multi-disciplinary Molecular Tumour Board, Beaumont RCSI Cancer Centre and full data along with treatment recommendation will be provided to the treating oncology team.

Study Type

Interventional

Enrollment (Estimated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Leonie Young
  • Phone Number: 00 353 1 797 7800
  • Email: lyoung@rcsi.com

Study Locations

  • Ireland
      • Cork, Ireland
        • Not yet recruiting
        • Cork University Hospital
        • Principal Investigator:
          • Roisin Connolly
        • Contact:
          • Cancer Clinical Trials Unit
      • Galway, Ireland
        • Not yet recruiting
        • University Hospital Galway
        • Contact:
          • Cancer Clinical Trials Unit
        • Principal Investigator:
          • Michael Kerrin
    • Leinster
      • Dublin, Leinster, Ireland, D09V2N0
        • Recruiting
        • Beaumont RCSI Cancer Centre
        • Principal Investigator:
          • Patrick Morris
        • Contact:
          • Cancer Clinical Trials Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients diagnosed with primary breast cancer attending hospital for the resection of their tumour tissue. Or Patients with suspected or confirmed brain metastatic breast cancer (Patient has a history of a biopsy or surgically (i.e. pathologically) confirmed primary breast cancer) attending hospital for the resection/biopsy and/or treatment of their tumour tissue. Or Patients with suspected (but not necessarily biopsy confirmed) newly diagnosed brain metastatic breast cancer attending hospital for the resection/biopsy and/or treatment of their tumour tissue.
  2. Patients receiving neoadjuvant treatment are also eligible (if applicable).
  3. Patients must be ≥ 18 years of age.
  4. Patients must be able to give informed consent.

Exclusion Criteria:

  1. Patients who do not have a confirmed diagnosis of primary breast cancer.
  2. Patients whose participation, in the opinion of the PI, would not be in their best interest, or those whom in the opinion of the PI would be unsuitable for study for reasons of infirmity or poor health.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Intervention: TSO 500
Utilisation of TSO500 assay to identify somatic, clinically actionable somatic in the primary breast tumour and, where relevant, brain metastatic tumour to the treating physician to inform clinical management of participating patients
Diagnostic test: TSO500 Assay
Utilisation of TSO500 assay to identify somatic, clinically actionable somatic in the primary breast tumour and, where relevant, brain metastatic tumour to the treating physician to inform clinical management of participating patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of enrolled patients with at least one clinically actionable mutation identified by PRISM diagnostics compared with standard-of-care diagnostics.
Time Frame: At the time of therapeutic decision following diagnostic assessment (up to 6 weeks from enrollment).
At the time of therapeutic decision following diagnostic assessment (up to 6 weeks from enrollment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Trials Ireland

Collaborators

Royal College of Surgeons, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2025

Primary Completion (Estimated)

December 30, 2030

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRIAL-IE 25-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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