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TAILORx Tissue Bank

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ClinicalTrials.gov Identifier: NCT02050750
Recruitment Status : Active, not recruiting
First Posted : January 31, 2014
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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 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)
Actual Study Start Date : December 2013
Actual Primary Completion Date : November 29, 2017
Estimated Study Completion Date : November 2030

Resource links provided by the National Library of Medicine


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



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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.
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

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


Locations
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, 24
St Vincent Universtiy Hospital
Dublin, Ireland, 4
St James Hospital
Dublin, Ireland, 8
Beaumont Hospital
Dublin, Ireland, 9
Mater Misericordiae University Hospital
Dublin, Ireland
Galway University Hospital
Galway, Ireland
Midwestern Regional Hospital
Limerick, Ireland
Sligo General Hosptial
Sligo, Ireland
Waterford Regional Hospital
Waterford, Ireland
Sponsors and Collaborators
Cancer Trials Ireland

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: October 12, 2018
Last Verified: October 2018

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