TAILORx Tissue Bank

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Cancer Trials Ireland
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland
ClinicalTrials.gov Identifier:
NCT02050750
First received: January 24, 2014
Last updated: June 27, 2016
Last verified: June 2016
  Purpose
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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breast Cancer Bank of Tissue From Trial Assigning Individualized Options for Treatment (TAILORx Tissue Bank)

Resource links provided by NLM:


Further study details as provided by Cancer Trials Ireland:

Primary Outcome Measures:
  • Disease relapse, endocrine and/or chemotherapy resistance prognosis [ Time Frame: For duration of follow up, expected 10 years ] [ Designated as safety issue: No ]
    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:
  • Signature/biomarkers [ Time Frame: For the duration of follow up, expected 10 years ] [ Designated as safety issue: No ]
    Validation of emerging signature/biomarkers


Estimated Enrollment: 690
Study Start Date: December 2013
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
TAILORx ICORG 06-31
Patients must have participated in TAILORx ICORG 06-31, participated in trial arms, and have adequate tumour tissue available

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders 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.
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050750

Locations
Ireland
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         
Beaumont Hospital Recruiting
Dublin, Ireland, 9
Contact: Contact Person    01-8092680      
Principal Investigator: Arnold Hill, Prof         
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         
Mater Misericordiae University Hospital Recruiting
Dublin, Ireland
Contact: Contact Person    01-8032000      
Principal Investigator: Cathy Kelly, 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         
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 
Study First Received: January 24, 2014
Last Updated: June 27, 2016
Health Authority: Ireland: Health Information and Quality Authority

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
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 25, 2016