Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 4:08 AM
Study NCT ID:
NCT07425002
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Oncology Clinical Diagnostic Study In Primary and Metastatic Breast Cancer (PRISM)
Sponsor:
Cancer Trials Ireland
Organization:
Study Overview
Official Title:
Precision Oncology Clinical Diagnostic Study In Primary and Metastatic Breast Cancer (PRISM)
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRISM
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: