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NCT Number: NCT07425002

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beaumont RCSI Cancer Centre, Dublin, Leinster, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
Patients receiving neoadjuvant treatment are also eligible (if applicable).
Patients must be ≥ 18 years of age.
Patients must be able to give informed consent.

Exclusion criteria

Patients who do not have a confirmed diagnosis of primary breast cancer.
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.

Treatment and study plan

TSO500 Assay

Diagnostic Test

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.

Primary outcomes

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Trials Ireland

CONTACT

[email protected]

00353 1 6677211

Leonie Young

CONTACT

[email protected]

00 353 1 797 7800

Sponsors and collaborators

Lead sponsor

Cancer Trials Ireland

Network

Collaborators

Royal College of Surgeons, Ireland

Registry information

Acronym: PRISM

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2030
First posted: Feb 20, 2026
Registry last updated: Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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