TAILORx Tissue Bank

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT02050750
• Lead Sponsor: Cancer Trials Ireland

Brief Summary

This is an exploratory, translational, non-interventional and multi-centre biobank. The aim of the development of such a biobank is to identify potential biomarkers that are indicative of disease relapse.

Detailed Description

The primary objective is to develop a biobank, tissue microarrays (TMAs) and full face sections, which will be used to identify candidate/ novel biomarkers prognostic for disease relapse and predictive for endocrine and/or chemotherapy resistance.

The secondary objectives are:

* To validate emerging signatures/biomarkers identified.

* To develop new assays for the breast cancer clinic.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-24
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Primary Completion: 2020-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06
• Study Completion: 2031-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Patients that were registered with the ICORG 06-31 TAILORx trial and participated in trial arms
• Patients with adequate tumor tissue available

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease relapse, endocrine and/or chemotherapy resistance prognosis	For duration of follow up, expected 10 years	A biobank, TMAs and full face sections, will allow for the identification of candidate/novel biomarkers prognostic for disease relapse and predictive for endocrine and/or chemotherapy resistance

Secondary Outcome Measures

Name	Time	Method
Signature/biomarkers	For the duration of follow up, expected 10 years	Validation of emerging signature/biomarkers

Trial Locations

Locations (12)

Waterford Regional Hospital; 🇮🇪 Waterford, Ireland

Letterkenny General Hospital; 🇮🇪 Donegal, Ireland

Cork University Hospital; 🇮🇪 Cork, Ireland

Adelaide and Meath National Children's Hospital Tallaght; 🇮🇪 Dublin, Ireland

Bons Secours Hospital; 🇮🇪 Cork, Ireland

Beaumont Hospital; 🇮🇪 Dublin, Ireland

Midwestern Regional Hospital; 🇮🇪 Limerick, Ireland

St James Hospital; 🇮🇪 Dublin, Ireland

Mater Misericordiae University Hospital; 🇮🇪 Dublin, Ireland

Galway University Hospital; 🇮🇪 Galway, Ireland

Sligo General Hosptial; 🇮🇪 Sligo, Ireland

St Vincent Universtiy Hospital; 🇮🇪 Dublin, Ireland