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TAILORx Tissue Bank

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ClinicalTrials.gov Identifier: NCT02050750
Recruitment Status : Recruiting
First Posted : January 31, 2014
Last Update Posted : August 10, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Breast Cancer

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 Design

Study Type : Observational
Estimated Enrollment : 690 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast Cancer Bank of Tissue From Trial Assigning Individualized Options for Treatment (TAILORx Tissue Bank)
Study Start Date : December 2013
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Patients must have participated in TAILORx ICORG 06-31, participated in trial arms, and have adequate tumour tissue available

Outcome Measures

Primary Outcome Measures :
  1. Disease relapse, endocrine and/or chemotherapy resistance prognosis [ Time Frame: 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 :
  1. Signature/biomarkers [ Time Frame: For the duration of follow up, expected 10 years ]
    Validation of emerging signature/biomarkers

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will consist only of patients that participated in the TAILORx ICORG 06-31 trial. These patients must have participated in trial arms relevant to ICORG 06-31 study and have adequate tumour tissue available.

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02050750

Bons Secours Hospital Recruiting
Cork, Ireland
Contact: Contact Person    021-4343703      
Principal Investigator: Brian Bird, Dr         
Cork University Hospital Recruiting
Cork, Ireland
Contact: Contact Person    021-4921301      
Principal Investigator: Seamus O'Reilly, Dr         
Letterkenny General Hospital Recruiting
Donegal, Ireland
Contact: Contact Person    074-9123798      
Principal Investigator: Karen Duffy, Dr         
Adelaide and Meath National Children's Hospital Tallaght Not yet recruiting
Dublin, Ireland, 24
Contact: Contact Person    01-4142000      
Principal Investigator: Janice Walshe, Dr         
St Vincent Universtiy Hospital Recruiting
Dublin, Ireland, 4
Contact: Contact Person    01-2094725      
Principal Investigator: Susan Kennedy, Prof         
Principal Investigator: John Crown, Prof         
St James Hospital Recruiting
Dublin, Ireland, 8
Contact: Contact Person    01-4103546      
Principal Investigator: John Kennedy, Dr         
Beaumont Hospital Recruiting
Dublin, Ireland, 9
Contact: Contact Person    01-8092680      
Principal Investigator: Arnold Hill, Prof         
Mater Misericordiae University Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    01-8032000      
Principal Investigator: Cathy Kelly, Dr         
Galway University Hospital Recruiting
Galway, Ireland
Contact: Contact Person    091-544735      
Principal Investigator: Maccon Keane, Dr         
Midwestern Regional Hospital Recruiting
Limerick, Ireland
Contact: Contact Person    061-482542      
Principal Investigator: Rajnish Gupta, Prof         
Sligo General Hosptial Recruiting
Sligo, Ireland
Contact: Contact Person    071-9171111      
Principal Investigator: Michael Martin, Dr         
Waterford Regional Hospital Recruiting
Waterford, Ireland
Contact: Contact Person    051-848000      
Principal Investigator: Miriam O'Connor, Dr         
Sponsors and Collaborators
Cancer Trials Ireland
More Information

Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT02050750     History of Changes
Other Study ID Numbers: ICORG 12-30
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017

Keywords provided by Cancer Trials Ireland:
Must have registered with the ICORG 06-31 TAILORx trial

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases