Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-11 @ 10:06 PM
Study NCT ID:
NCT03237195
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2017-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility and Cost-effectiveness of Microscopic Examination of the Neck Dissection.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D037981', 'term': 'Neck Dissection'}], 'ancestors': [{'id': 'D008197', 'term': 'Lymph Node Excision'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-16', 'studyFirstSubmitDate': '2017-07-28', 'studyFirstSubmitQcDate': '2017-07-28', 'lastUpdatePostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of additional lymph nodes obtained with additional sampling of soft tissue', 'timeFrame': '3 years', 'description': 'Number of additional lymph nodes obtained with additional sampling of soft tissue'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastasis']}, 'referencesModule': {'references': [{'pmid': '9735105', 'type': 'RESULT', 'citation': 'Gillies EM, Luna MA. Histologic evaluation of neck dissection specimens. Otolaryngol Clin North Am. 1998 Oct;31(5):759-71. doi: 10.1016/s0030-6665(05)70085-2.'}, {'pmid': '12599286', 'type': 'RESULT', 'citation': 'Jose J, Coatesworth AP, MacLennan K. Cervical metastases in upper aerodigestive tract squamous cell carcinoma: histopathologic analysis and reporting. Head Neck. 2003 Mar;25(3):194-7. doi: 10.1002/hed.10194.'}, {'pmid': '20596978', 'type': 'RESULT', 'citation': 'Seethala RR. Current state of neck dissection in the United States. Head Neck Pathol. 2009 Sep;3(3):238-45. doi: 10.1007/s12105-009-0129-y. Epub 2009 Aug 7.'}, {'pmid': '20670137', 'type': 'RESULT', 'citation': 'Muirhead D, Aoun P, Powell M, Juncker F, Mollerup J. Pathology economic model tool: a novel approach to workflow and budget cost analysis in an anatomic pathology laboratory. Arch Pathol Lab Med. 2010 Aug;134(8):1164-9. doi: 10.5858/2000-0401-OA.1.'}, {'pmid': '1384570', 'type': 'RESULT', 'citation': 'van den Brekel MW, Stel HV, van der Valk P, van der Waal I, Meyer CJ, Snow GB. Micrometastases from squamous cell carcinoma in neck dissection specimens. Eur Arch Otorhinolaryngol. 1992;249(6):349-53. doi: 10.1007/BF00179388.'}]}, 'descriptionModule': {'briefSummary': 'Most patients with cancer of the head and neck are offered surgical resection of the primary tumor. In order to determine how the tumor will eventually behave, along with the resection of the primary tumor, lymph nodes present in the neck are also dissected. Different institutes have different protocol on handling of the specimen that is received by the pathology labs after dissection of the neck. The investigators intend to analyze the protocol that they use to evaluate the neck dissection specimen.', 'detailedDescription': 'This will be a retrospective study. All neck dissections received in the histology laboratory from Jan 2013 to December 2016 will be retrieved from the histopathology files by conducting a search through CoPath. The glass slides of all the neck dissections that fit the study criterion will be retrieved from the archives. The glass slides will be reviewed by the pathologist.\n\nAt the time of review number of lymph nodes identified microscopically, presence or absence of metastasis and if the Lymph Nodes (LN) were palpable or not palpable will be documented. The data will be analyzed to see if the submission of extra fat yielded any additional positive lymph nodes or microscopic deposits. The cost analysis for additional slides will be also done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who underwent neck dissection for squamous cell carcinomas of head and neck origin.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Neck dissection (unilateral and/or bilateral)\n2. Primary squamous cell carcinoma of head and neck\n\nExclusion Criteria:\n\n1\\. Any neck dissection performed outside UMMC and case received as a consult.'}, 'identificationModule': {'nctId': 'NCT03237195', 'briefTitle': 'Utility and Cost-effectiveness of Microscopic Examination of the Neck Dissection.', 'organization': {'class': 'OTHER', 'fullName': 'University of Mississippi Medical Center'}, 'officialTitle': 'Utility and Cost-effectiveness of Microscopic Examination of the Neck Dissection Specimen in Its Entirety.', 'orgStudyIdInfo': {'id': '2016-0288'}}, 'armsInterventionsModule': {'interventions': [{'name': 'additional soft tissue in neck dissections', 'type': 'OTHER', 'description': 'Evaluation of submission of additional soft tissue in neck dissections for head and neck squamous cell carcinomas'}]}, 'contactsLocationsModule': {'locations': [{'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}], 'overallOfficials': [{'name': 'Varsha Manucha', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mississippi Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}