Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-27 @ 7:44 AM
Study NCT ID:
NCT01051492
Status:
UNKNOWN
Last Update Posted:
2014-01-14
First Post:
2010-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Predictive Biomarkers and Novel Approached to Therapy in Breast Cancer
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-01-13', 'studyFirstSubmitDate': '2010-01-15', 'studyFirstSubmitQcDate': '2010-01-15', 'lastUpdatePostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '19088019', 'type': 'BACKGROUND', 'citation': 'Tan SH, Lee SC, Goh BC, Wong J. Pharmacogenetics in breast cancer therapy. Clin Cancer Res. 2008 Dec 15;14(24):8027-41. doi: 10.1158/1078-0432.CCR-08-0993.'}, {'pmid': '16361630', 'type': 'BACKGROUND', 'citation': 'Goetz MP, Rae JM, Suman VJ, Safgren SL, Ames MM, Visscher DW, Reynolds C, Couch FJ, Lingle WL, Flockhart DA, Desta Z, Perez EA, Ingle JN. Pharmacogenetics of tamoxifen biotransformation is associated with clinical outcomes of efficacy and hot flashes. J Clin Oncol. 2005 Dec 20;23(36):9312-8. doi: 10.1200/JCO.2005.03.3266.'}]}, 'descriptionModule': {'briefSummary': 'Breast cancer is a common malignancy world-wide, and is the commonest female malignancy in Singapore, with rising trends in incidence over the last 2 decades. While there have been improvements in treatment, mortality from breast cancer remains significant. Development of biomarkers to predict treatment response and toxicity to anti-cancer agents can rationalize the choice of therapy for the individual patients to optimize treatment outcome and to reduce unnecessary toxicities. Development of novel therapies or novel approaches to therapy is also critical to improve the treatment armamentarium in breast cancer. These research strategies will have an significant impact on breast cancer treatment both in Singapore as well as globally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any individual who has been diagnosed with breast cancer', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThis program will recruit mainly cancer patients, predominantly breast cancer patients. The exact inclusion criteria will vary between each individual study. Each individual component study will be submitted to DSRB for separate approval, along with the study protocol and patient informed consent sheet.\n\nExclusion Criteria:\n\nThe exact exclusion criteria will vary between each individual study. Each individual component study will be submitted to DSRB for separate approval, along with the study protocol and patient informed consent sheet.'}, 'identificationModule': {'nctId': 'NCT01051492', 'briefTitle': 'Development of Predictive Biomarkers and Novel Approached to Therapy in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'orgStudyIdInfo': {'id': 'BR07/30/09'}}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Soo Chin Lee, MBBS, MRCP', 'role': 'CONTACT', 'email': 'soo_chin_lee@nuhs.edu.sg', 'phone': '65 6772 4629'}, {'name': 'Soo Chin Lee, MBBS, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National University Hospital Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Soo Chin Lee, MBBS, MRCP', 'role': 'CONTACT', 'email': 'soo_chin_lee@nuhs.edu.sg', 'phone': '65 6772 4629'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}}}}