RecruitingNot ApplicableNCT07425002

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


Sponsor

Cancer Trials Ireland

Enrollment

1,600 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting and analyzing tumor tissue from breast cancer patients — including those with cancer that has spread to the brain — to better understand tumor biology and improve future treatments. **You may be eligible if...** - You have been diagnosed with primary breast cancer and are having your tumor surgically removed - You have suspected or confirmed breast cancer that has spread to the brain and are scheduled for surgery or biopsy - You are 18 or older - You are able to give informed consent - You may be receiving neoadjuvant (pre-surgery) treatment and are still eligible **You may NOT be eligible if...** - You do not have a confirmed primary breast cancer diagnosis - In the opinion of the study investigator, your participation would not be in your best interest due to poor health or other concerns Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTTSO500 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.


Locations(3)

Beaumont RCSI Cancer Centre

Dublin, Leinster, Ireland

Cork University Hospital

Cork, Ireland

University Hospital Galway

Galway, Ireland

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NCT07425002


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