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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Ireland
Cork University Hospital
NOT_YET_RECRUITING
Cork
Beaumont RCSI Cancer Centre
RECRUITING
Dublin
University Hospital Galway
NOT_YET_RECRUITING
Galway
Contact Information
Primary
Cancer Trials Ireland
info@cancertrials.ie
00353 1 6677211
Backup
Leonie Young
lyoung@rcsi.com
00 353 1 797 7800
Time Frame
Start Date: 2025-11-11
Estimated Completion Date: 2030-12-30
Participants
Target number of participants: 1600
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Cancer Trials Ireland
Collaborators: Royal College of Surgeons, Ireland

This content was sourced from clinicaltrials.gov

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