Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 4:40 PM
Study NCT ID:
NCT01943032
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2013-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Discordant Hormonal Status of 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Paraffin embedded tissue blocks of primary breast tumor and axillary lymph nodes.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2013-09-10', 'studyFirstSubmitQcDate': '2013-09-11', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association of hormonal status between primary breast tumor and axillary lymph nodes', 'timeFrame': 'Up to 1 year', 'description': 'Association of estrogen and progesterone status between primary breast tumor and axillary lymph nodes was analyzed by using the χ2 test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malignant Neoplasm of Breast.']}, 'referencesModule': {'references': [{'pmid': '15317891', 'type': 'BACKGROUND', 'citation': 'Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.'}, {'pmid': '19914540', 'type': 'BACKGROUND', 'citation': 'Cristofanilli M. The biological information obtainable from circulating tumor cells. Breast. 2009 Oct;18 Suppl 3:S38-40. doi: 10.1016/S0960-9776(09)70270-X.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine discordant hormonal status of primary breast tumor and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer patients.', 'detailedDescription': 'Hormonal status between primary breast tumor and axillary lymph node were analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast Cancer Patients Stage I,II and III.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer patients stage I,II and III with axillary lymph nodes metastasis.\n\nExclusion Criteria:\n\n* Breast cancer patients stage I,II and III without axillary lymph nodes metastasis.'}, 'identificationModule': {'nctId': 'NCT01943032', 'briefTitle': 'Discordant Hormonal Status of Breast Cancer.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Institute, Thailand'}, 'officialTitle': 'Discordant Hormonal Status Between Primary Tumor and Axillary Lymph Node in Breast Cancer Patients.', 'orgStudyIdInfo': {'id': 'EC 196/2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Breast Tumor', 'description': 'Immunohistochemical staining of paraffin embedded tissue blocks of primary breast tumor for estrogen and progesterone receptors was performed.'}, {'label': 'Axillary Lymph Nodes.', 'description': 'Immunohistochemical staining of paraffin embedded tissue blocks of axillary lymph nodes for estrogen and progesterone receptors was performed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Ratchathewi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'National Cancer Institute, Thailand.', 'geoPoint': {'lat': 13.759, 'lon': 100.53358}}], 'overallOfficials': [{'name': 'AKANIST PIYAPANT, MD.,FRCST.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD.,FRCST. Surgical Oncologist.', 'investigatorFullName': 'AKANIST PIYAPANT, MD.,FRCST.', 'investigatorAffiliation': 'National Cancer Institute, Thailand'}}}}