Clinical trial NCT02050750: TAILORx Tissue Bank
Official title: Breast Cancer Bank of Tissue From Trial Assigning Individualized Options for Treatment (TAILORx Tissue Bank)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Must have registered with the ICORG 06-31 TAILORx trial
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2014-01-31
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Disease relapse, endocrine and/or chemotherapy resistance prognosis
timeFrame: For duration of follow up, expected 10 years
Secondary outcomes:
measure: Signature/biomarkers
timeFrame: For the duration of follow up, expected 10 years
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Bons Secours Hospital
city: Cork
country: Ireland
facility: Cork University Hospital
city: Donegal
country: Ireland
facility: Letterkenny General Hospital
city: Dublin
country: Ireland
facility: Adelaide and Meath National Children's Hospital Tallaght
city: Dublin
country: Ireland
facility: St Vincent Universtiy Hospital
city: Dublin
country: Ireland
facility: St James Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Galway
country: Ireland
facility: Galway University Hospital
city: Limerick
country: Ireland
facility: Midwestern Regional Hospital
city: Sligo
country: Ireland
facility: Sligo General Hosptial
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
Study officials:
References:
citation: Lynch SM, Russell NM, Barron S, Wang CA, Loughman T, Dynoodt P, Fender B, Lopez-Ruiz C, O'Grady A, Sheehan KM, Fay J, Amberger-Murphy V, Saha A, Klinger R, Gonzalez CA, Al-Attar N, Rahman A, O'Leary D, Lanigan FT, Bracken AP, Crown J, Kelly CM, O'Connor DP, Gallagher WM. Prognostic value of the 6-gene OncoMasTR test in hormone receptor-positive HER2-negative early-stage breast cancer: Comparative analysis with standard clinicopathological factors. Eur J Cancer. 2021 Jul;152:78-89. doi: 10.1016/j.ejca.2021.04.016. Epub 2021 Jun 2.