Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-24 @ 5:59 PM
Study NCT ID:
NCT02050750
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2014-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAILORx Tissue Bank
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2014-01-24', 'studyFirstSubmitQcDate': '2014-01-30', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease relapse, endocrine and/or chemotherapy resistance prognosis', 'timeFrame': 'For duration of follow up, expected 10 years', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Signature/biomarkers', 'timeFrame': 'For the duration of follow up, expected 10 years', 'description': 'Validation of emerging signature/biomarkers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Must have registered with the ICORG 06-31 TAILORx trial'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34090143', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe secondary objectives are:\n\n* To validate emerging signatures/biomarkers identified.\n* To develop new assays for the breast cancer clinic.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that were registered with the ICORG 06-31 TAILORx trial and participated in trial arms\n* Patients with adequate tumor tissue available'}, 'identificationModule': {'nctId': 'NCT02050750', 'briefTitle': 'TAILORx Tissue Bank', 'organization': {'class': 'NETWORK', 'fullName': 'Cancer Trials Ireland'}, 'officialTitle': 'Breast Cancer Bank of Tissue From Trial Assigning Individualized Options for Treatment (TAILORx Tissue Bank)', 'orgStudyIdInfo': {'id': 'ICORG 12-30'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAILORx ICORG 06-31', 'description': 'Patients must have participated in TAILORx ICORG 06-31, participated in trial arms, and have adequate tumour tissue available'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cork', 'country': 'Ireland', 'facility': 'Bons Secours Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Cork', 'country': 'Ireland', 'facility': 'Cork University Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Donegal', 'country': 'Ireland', 'facility': 'Letterkenny General Hospital', 'geoPoint': {'lat': 54.65378, 'lon': -8.11134}}, {'zip': '24', 'city': 'Dublin', 'country': 'Ireland', 'facility': "Adelaide and Meath National Children's Hospital Tallaght", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '4', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'St Vincent Universtiy Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '8', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'St James Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '9', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Mater Misericordiae University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Galway', 'country': 'Ireland', 'facility': 'Galway University Hospital', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'city': 'Limerick', 'country': 'Ireland', 'facility': 'Midwestern Regional Hospital', 'geoPoint': {'lat': 52.66472, 'lon': -8.62306}}, {'city': 'Sligo', 'country': 'Ireland', 'facility': 'Sligo General Hosptial', 'geoPoint': {'lat': 54.26969, 'lon': -8.46943}}, {'city': 'Waterford', 'country': 'Ireland', 'facility': 'Waterford Regional Hospital', 'geoPoint': {'lat': 52.25833, 'lon': -7.11194}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Trials Ireland', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}