Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-06 @ 5:02 AM
Study NCT ID:
NCT01840293
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2013-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Cancer Proteomics and Molecular Heterogeneity
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': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1780}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2038-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2013-04-23', 'studyFirstSubmitQcDate': '2013-04-23', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigation of proteins and their pathways in primary breast cancer', 'timeFrame': '10 years', 'description': 'Investigation of proteins and their pathways in primary breast cancer, which are associated with patient outcome.'}], 'secondaryOutcomes': [{'measure': 'Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer', 'timeFrame': '10 years'}, {'measure': 'Identification of novel molecular mechanisms of breast cancer recurrence', 'timeFrame': '10 years', 'description': 'Identification of novel molecular mechanisms of breast cancer recurrence, therapy resistance and/or metastasis'}, {'measure': 'Determination of novel potential molecular targets', 'timeFrame': '10 years', 'description': 'Determination of novel potential molecular targets that can be used to develop future prevention and treatment advances in patients with breast cancer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Breast Cancer', 'Recurrent/Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '33208158', 'type': 'DERIVED', 'citation': "Charmsaz S, Doherty B, Cocchiglia S, Vareslija D, Marino A, Cosgrove N, Marques R, Priedigkeit N, Purcell S, Bane F, Bolger J, Byrne C, O'Halloran PJ, Brett F, Sheehan K, Brennan K, Hopkins AM, Keelan S, Jagust P, Madden S, Martinelli C, Battaglini M, Oesterreich S, Lee AV, Ciofani G, Hill ADK, Young LS. ADAM22/LGI1 complex as a new actionable target for breast cancer brain metastasis. BMC Med. 2020 Nov 19;18(1):349. doi: 10.1186/s12916-020-01806-4."}, {'pmid': '28399921', 'type': 'DERIVED', 'citation': 'Charmsaz S, Hughes E, Bane FT, Tibbitts P, McIlroy M, Byrne C, Cocchiglia S, McBryan J, Hennessy BT, Dwyer RM, Kerin MJ, Hill AD, Young LS. S100beta as a serum marker in endocrine resistant breast cancer. BMC Med. 2017 Apr 12;15(1):79. doi: 10.1186/s12916-017-0836-2.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\nThe primary objective is to define the proteomic and molecular characteristics of primary and recurrent/ metastatic breast tumours with special focus on the expression of S100 protein and the estrogen receptor (ER), progesterone receptor (PR) and epidermal growth factor receptor 2 (HER2) genes\n\nSecondary objective:\n\n* To expand our understanding of the complex molecular pathways dictating the progression of breast cancer and their response to different treatment regimes.\n* To relate proteomic findings to survival data\n* To identify potential serum markers of breast cancer progression', 'detailedDescription': 'This is a translational study. Patient will undergo standard treatment and tissue and blood samples will be taken at various time points:\n\nTissue: Fresh frozen (FF) and Formalin fixed paraffin embedded tissue (FFPE) will be collected at time of surgery/biopsy of a primary or a recurrent/metastatic tumour tissue.\n\nBlood: Two types of study bloods (non-heparinised and Ethylenediaminetetraacetic acid (EDTA)) will be taken pre-neoadjuvant treatment (if applicable), pre- and post-operatively of primary and recurrent/ metastatic breast cancer (if recurrent/metastatic diagnosis and no biopsy/surgery required then study bloods will be taken prior to starting treatment).\n\nAdditional blood samples will be taken annually at follow-up visits for 5 years from primary cases and for up to 2 years from recurrent/metastatic cases.\n\nNon-heparinised blood will be processed to serum. Clinical data will be collected at all times of biological sampling.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All newly diagnosed breast cancer patients, recurrent and stage IV metastatic breast cancer patients.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with primary breast cancer attending hospital for the resection of their tumour tissue\n\n Or\n\n -Patients with suspected or confirmed recurrent or metastatic breast cancer (Patient has a history of a biopsy- or surgically- (i.e. pathologically) confirmed primary breast cancer) attending hospital for the resection/biopsy and/or treatment of tumour tissue\n\n Or\n\n -Patient with suspected (but not necessarily biopsy confirmed) newly diagnosed stage 4 breast cancer attending hospital for the resection/biopsy and/or treatment of their tumour tissue\n2. Patients receiving neoadjuvant treatment are also eligible (if applicable)\n3. Patients have to be ≥ 18 years of age\n4. Patients must be able to give informed consent'}, 'identificationModule': {'nctId': 'NCT01840293', 'briefTitle': 'Breast Cancer Proteomics and Molecular Heterogeneity', 'organization': {'class': 'NETWORK', 'fullName': 'Cancer Trials Ireland'}, 'officialTitle': 'Breast Cancer Proteomics and Molecular Heterogeneity', 'orgStudyIdInfo': {'id': 'ICORG 09-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Breast Cancer'}, {'label': 'Recurrent/Metastatic Breast Cancer'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cork', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Cancer Clinical Trials Unit', 'role': 'CONTACT', 'phone': '021 4234816'}, {'name': 'Paul Redmond', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cork University Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Dublin', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '01- 809 3000'}, {'name': 'Arnold Hill, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Bryan Hennessy, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'status': 'COMPLETED', 'country': 'Ireland', 'facility': "St James's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Dublin', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'CCRT', 'role': 'CONTACT', 'phone': '01 221 4000'}, {'name': 'Janice Walshe', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Vincent's University Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Limerick', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Ireland', 'facility': 'University Hospital Limerick', 'geoPoint': {'lat': 52.66472, 'lon': -8.62306}}, {'city': 'Waterford', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Cancer Clinical Trials Office', 'role': 'CONTACT', 'phone': '051 848 000'}, {'name': "Gerry O'Donoghue", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Waterford', 'geoPoint': {'lat': 52.25833, 'lon': -7.11194}}], 'centralContacts': [{'name': 'Cancer Trials Ireland', 'role': 'CONTACT', 'email': 'info@cancertrials.ie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Trials Ireland', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}