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TAILORx Tissue Bank

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT02050750
First received: January 24, 2014
Last updated: June 26, 2014
Last verified: January 2014

January 24, 2014
June 26, 2014
December 2013
June 2018   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02050750 on ClinicalTrials.gov Archive Site
Signature/biomarkers [ Time Frame: For the duration of follow up, expected 10 years ] [ Designated as safety issue: No ]
Validation of emerging signature/biomarkers
Same as current
Not Provided
Not Provided
 
TAILORx Tissue Bank
Breast Cancer Bank of Tissue From Trial Assigning Individualized Options for Treatment (TAILORx Tissue Bank)

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Breast Cancer
Not Provided
TAILORx ICORG 06-31
Patients must have participated in TAILORx ICORG 06-31, participated in trial arms, and have adequate tumour tissue available
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
690
Not Provided
June 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients that were registered with the ICORG 06-31 TAILORx trial and participated in trial arms
  • Patients with adequate tumor tissue available
Female
18 Years to 75 Years
No
Ireland
 
NCT02050750
ICORG 12-30
No
ICORG- All Ireland Cooperative Oncology Research Group
ICORG- All Ireland Cooperative Oncology Research Group
Not Provided
Not Provided
ICORG- All Ireland Cooperative Oncology Research Group
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP