Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-27 @ 8:58 PM
Study NCT ID:
NCT00002695
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 530}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2011-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-04-10', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-10-18', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage I squamous cell carcinoma of the lip and oral cavity', 'stage II squamous cell carcinoma of the lip and oral cavity', 'stage III squamous cell carcinoma of the lip and oral cavity', 'stage IV squamous cell carcinoma of the lip and oral cavity', 'recurrent squamous cell carcinoma of the lip and oral cavity', 'stage I squamous cell carcinoma of the oropharynx', 'stage II squamous cell carcinoma of the oropharynx', 'stage III squamous cell carcinoma of the oropharynx', 'stage IV squamous cell carcinoma of the oropharynx', 'recurrent squamous cell carcinoma of the oropharynx', 'stage I squamous cell carcinoma of the hypopharynx', 'stage II squamous cell carcinoma of the hypopharynx', 'stage III squamous cell carcinoma of the hypopharynx', 'stage IV squamous cell carcinoma of the hypopharynx', 'recurrent squamous cell carcinoma of the hypopharynx', 'stage I squamous cell carcinoma of the larynx', 'stage II squamous cell carcinoma of the larynx', 'stage III squamous cell carcinoma of the larynx', 'stage IV squamous cell carcinoma of the larynx', 'recurrent squamous cell carcinoma of the larynx', 'stage I squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage II squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage III squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity', 'recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '19770416', 'type': 'RESULT', 'citation': 'Koch WM, Ridge JA, Forastiere A, Manola J. Comparison of clinical and pathological staging in head and neck squamous cell carcinoma: results from Intergroup Study ECOG 4393/RTOG 9614. Arch Otolaryngol Head Neck Surg. 2009 Sep;135(9):851-8. doi: 10.1001/archoto.2009.123.'}, {'pmid': '18223210', 'type': 'RESULT', 'citation': 'Westra WH, Taube JM, Poeta ML, Begum S, Sidransky D, Koch WM. Inverse relationship between human papillomavirus-16 infection and disruptive p53 gene mutations in squamous cell carcinoma of the head and neck. Clin Cancer Res. 2008 Jan 15;14(2):366-9. doi: 10.1158/1078-0432.CCR-07-1402.'}, {'pmid': '18094376', 'type': 'RESULT', 'citation': 'Poeta ML, Manola J, Goldwasser MA, Forastiere A, Benoit N, Califano JA, Ridge JA, Goodwin J, Kenady D, Saunders J, Westra W, Sidransky D, Koch WM. TP53 mutations and survival in squamous-cell carcinoma of the head and neck. N Engl J Med. 2007 Dec 20;357(25):2552-61. doi: 10.1056/NEJMoa073770.'}, {'type': 'RESULT', 'citation': 'Poeta LM, Goldwasser MA, Forastiere A, et al.: Prognostic implication of p53 mutations in HNSCC: results of intragroup margin study (E4393). [Abstract] J Clin Oncol 24 (Suppl 18): A-5504, 2006.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Diagnostic procedures, such as analysis of tumor tissue and lymph nodes that have been surgically removed, may improve the treatment of patients with cancers of the head and neck.\n\nPURPOSE: Diagnostic trial to determine if analyzing tumor tissue and lymph nodes surgically removed from patients with cancers of the head and neck can predict recurrence of the cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine whether molecular detection of p53 mutation in cancerous cells of histologically negative tumor margins can predict local recurrence in patients with squamous cell carcinoma of the upper aerodigestive tract.\n* Determine the incidence of p53 mutation in this population and its correlation with clinical parameters.\n* Determine whether molecular detection of cancerous cells in lymph nodes from stage N0-1 neck dissections can predict survival and the risks of regional recurrence and distant metastases in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients undergo standard curative resection and neck node dissection (if appropriate). Specimens are collected from tumor tissue (necrosis-free, if possible), each wound quadrant, any neck disease with clinically negative nodes, and any neck disease with a single positive node for histologic and molecular analysis. Tissue and cells are examined for p53 mutation and DNA microsatellite repeat alterations. Patients undergo adjuvant radiotherapy and/or chemotherapy, as appropriate for clinical staging and histopathology, at the discretion of the participating clinician.\n\nPatients do not receive results of genetic testing and the results do not affect treatment.\n\nPatients are followed every 6 months for 3 years and then annually thereafter.\n\nPROJECTED ACCRUAL: A total 530 patients will be accrued for this study within 3.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of squamous cell carcinoma of the upper aerodigestive tract (excluding the nasopharynx) for which curative resection is scheduled\n\n * Recurrent disease allowed if resectable\n * Patients with clinically and histologically proven stage N0-1 neck disease who are undergoing dissection are eligible for analysis of occult nodal disease\n* No distant metastasis\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* No other malignancy within the past 5 years except nonmelanomatous skin cancer or lymphoma\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Prior limited chemotherapy to the index lesion allowed\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Prior limited radiotherapy to the index lesion allowed\n\nSurgery:\n\n* See Disease Characteristics\n* Prior limited surgery to the index lesion allowed'}, 'identificationModule': {'nctId': 'NCT00002695', 'briefTitle': 'Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'CLINICAL EFFICACY OF MOLECULAR ANALYSIS OF SURGICAL MARGINS AND REGIONAL LYMPH NODES IN MANAGEMENT OF HEAD AND NECK SQUAMOUS CELL CARCINOMA', 'orgStudyIdInfo': {'id': 'CDR0000064467'}, 'secondaryIdInfos': [{'id': 'E-4393'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'DNA stability analysis', 'type': 'GENETIC'}, {'name': 'microsatellite instability analysis', 'type': 'GENETIC'}, {'name': 'mutation analysis', 'type': 'GENETIC'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231-2410', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ireland Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '54301', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'CCOP - Green Bay', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}], 'overallOfficials': [{'name': 'Wayne M. Koch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ECOG-ACRIN Cancer Research Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}