Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-29 @ 11:19 AM
Study NCT ID:
NCT01484769
Status:
WITHDRAWN
Last Update Posted:
2017-04-10
First Post:
2011-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue samples from patients undergoing elective neck dissection will be collected. Primary tumors and adjacent normal tissue from unaffected areas will be collected at the time of surgery. All tissue dissection and removal are part of the standard of care for this type of surgical procedure. Remaining resected tissue will be used for research.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2011-11-30', 'studyFirstSubmitQcDate': '2011-12-01', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'Collection of tissues for analysis from patients undergoing elective neck dissection.\n\nThe hypothesis of the study is that specific genetic alterations occur in head and neck cancers that have spread to regional and/or distant sites, and these alterations can be identified from biopsy specimens to allow more accurate staging of tumor and better treatment planning.', 'detailedDescription': 'The standard of care for the treatment of most squamous cell carcinoma of the head and neck is surgical extirpation of the primary tumor and elective neck dissection to remove regional nodes at risk for spread. Via this treatment regimen, the investigators will be able to prospectively obtain tissues for analysis from patients undergoing elective neck dissection.\n\nThe specific aims of this study are to compare gene expression between head and neck tumors with and without regional lymph node metastases, and to compare gene expression between head and neck tumor with and without distant metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adults and minors diagnosed with squamous cell carcinoma of the head and neck that will undergo elective neck dissection surgery at either Norton Hospital, Kosair Children's Hospital, or University of Louisville Hospital.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with biochemical evidence of squamous cell carcinoma of the head and neck.\n\nExclusion Criteria:\n\n* Patients without biomedical evidence of squamous cell carcinoma.'}, 'identificationModule': {'nctId': 'NCT01484769', 'acronym': 'H&N', 'briefTitle': 'Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells', 'orgStudyIdInfo': {'id': '360.05'}}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': "Kosair Children's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}