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NCT02050750 Clinical Trial

TAILORx Tissue Bank

Breast Cancer Clinical Trial

Official title:
Breast Cancer Bank of Tissue From Trial Assigning Individualized Options for Treatment (TAILORx Tissue Bank)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02050750
Other study ID # ICORG 12-30
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 2013
Est. completion date November 2031

Study information
Verified date April 2023
Source Cancer Trials Ireland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 600
Est. completion date November 2031
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients that were registered with the ICORG 06-31 TAILORx trial and participated in trial arms - Patients with adequate tumor tissue available

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Ireland Bons Secours Hospital Cork
Ireland Cork University Hospital Cork
Ireland Letterkenny General Hospital Donegal
Ireland Adelaide and Meath National Children's Hospital Tallaght Dublin
Ireland Beaumont Hospital Dublin
Ireland Mater Misericordiae University Hospital Dublin
Ireland St James Hospital Dublin
Ireland St Vincent Universtiy Hospital Dublin
Ireland Galway University Hospital Galway
Ireland Midwestern Regional Hospital Limerick
Ireland Sligo General Hosptial Sligo
Ireland Waterford Regional Hospital Waterford

Sponsors (1)
Lead Sponsor Collaborator
Cancer Trials Ireland

Country where clinical trial is conducted

Ireland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease relapse, endocrine and/or chemotherapy resistance prognosis 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 For duration of follow up, expected 10 years
Secondary Signature/biomarkers Validation of emerging signature/biomarkers For the duration of follow up, expected 10 years
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