NCT02050750

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
67mo left

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Dec 2013Nov 2031

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
10.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2031

Expected
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

7 years

First QC Date

January 24, 2014

Last Update Submit

December 15, 2025

Conditions

Keywords

Must have registered with the ICORG 06-31 TAILORx trial

Outcome Measures

Primary Outcomes (1)

  • Disease relapse, endocrine and/or chemotherapy resistance prognosis

    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

    For duration of follow up, expected 10 years

Secondary Outcomes (1)

  • Signature/biomarkers

    For the duration of follow up, expected 10 years

Study Arms (1)

TAILORx ICORG 06-31

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

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Bons Secours Hospital

Cork, Ireland

Location

Cork University Hospital

Cork, Ireland

Location

Letterkenny General Hospital

Donegal, Ireland

Location

Adelaide and Meath National Children's Hospital Tallaght

Dublin, 24, Ireland

Location

St Vincent Universtiy Hospital

Dublin, 4, Ireland

Location

St James Hospital

Dublin, 8, Ireland

Location

Beaumont Hospital

Dublin, 9, Ireland

Location

Mater Misericordiae University Hospital

Dublin, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

Midwestern Regional Hospital

Limerick, Ireland

Location

Sligo General Hosptial

Sligo, Ireland

Location

Waterford Regional Hospital

Waterford, Ireland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 31, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2020

Study Completion (Estimated)

November 1, 2031

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations