Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-31 @ 4:52 PM
Study NCT ID:
NCT01683305
Status:
UNKNOWN
Last Update Posted:
2012-09-11
First Post:
2012-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker Breast Pap Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-10', 'studyFirstSubmitDate': '2012-09-07', 'studyFirstSubmitQcDate': '2012-09-10', 'lastUpdatePostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['biomarker,', 'NAF', 'Subjects'], 'conditions': ['Tumors']}, 'descriptionModule': {'briefSummary': 'This will be a Phase I study. During the Phase I study, our goals are: 1) screen a number of cancer biomarkers in Nipple Aspirate Fluid (NAF) from women who have no mammographically detectable tumors, and those who have detectable tumors, 2) identify all the detectable markers and 3) establish that biomarkers detected in NAF could also be detected in the biopsied tumor tissue that was removed for diagnostic purpose in subjects who have detectable tumors.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any woman age 18 or older', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any female subject aged 18 years or older\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01683305', 'briefTitle': 'Biomarker Breast Pap Test', 'organization': {'class': 'INDUSTRY', 'fullName': 'Silbiotech'}, 'orgStudyIdInfo': {'id': 'Silbiotech:2012-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects who have no mammographically detectable tumors', 'description': 'This group will be evaluated for marker presence in NAF. no drugs administered'}, {'label': 'Subjects who have non-cancerous growths', 'description': 'This group will be evaluated to study whether marker(s) detected in NAF are also expressed in non-cancerous tumors. No drugs administered'}, {'label': 'subjects who have cancerous growths', 'description': 'In this group, any markers detected in NAF could also be detected in tumor tissues. No drugs administered.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silbiotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Indira Poola, Ph.D', 'investigatorAffiliation': 'Silbiotech'}}}}