Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-02-21 @ 7:04 AM
Study NCT ID:
NCT01487733
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2011-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301
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'}, {'id': 'D012468', 'term': 'Salivary Gland Neoplasms'}], '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'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D017403', 'term': 'In Situ Hybridization'}, {'id': 'D007150', 'term': 'Immunohistochemistry'}], 'ancestors': [{'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013194', 'term': 'Staining and Labeling'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D009693', 'term': 'Nucleic Acid Hybridization'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2011-12-06', 'studyFirstSubmitQcDate': '2011-12-06', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment response', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['metastatic squamous neck cancer with occult primary squamous cell carcinoma', 'metastatic squamous neck cancer with occult primary', 'recurrent metastatic squamous neck cancer with occult primary', 'recurrent squamous cell carcinoma of the hypopharynx', 'recurrent squamous cell carcinoma of the larynx', 'recurrent squamous cell carcinoma of the lip and oral cavity', 'recurrent squamous cell carcinoma of the nasopharynx', 'recurrent squamous cell carcinoma of the oropharynx', 'recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity', 'salivary gland squamous cell carcinoma', 'stage III squamous cell carcinoma of the hypopharynx', 'stage III squamous cell carcinoma of the larynx', 'stage III squamous cell carcinoma of the lip and oral cavity', 'stage III squamous cell carcinoma of the nasopharynx', 'stage III squamous cell carcinoma of the oropharynx', 'stage III squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage IV squamous cell carcinoma of the hypopharynx', 'stage IVA squamous cell carcinoma of the larynx', 'stage IVA squamous cell carcinoma of the lip and oral cavity', 'stage IVA squamous cell carcinoma of the oropharynx', 'stage IVA squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage IVB squamous cell carcinoma of the larynx', 'stage IVB squamous cell carcinoma of the lip and oral cavity', 'stage IVB squamous cell carcinoma of the oropharynx', 'stage IVB squamous cell carcinoma of the paranasal sinus and nasal cavity', 'stage IVC squamous cell carcinoma of the larynx', 'stage IVC squamous cell carcinoma of the lip and oral cavity', 'stage IVC squamous cell carcinoma of the oropharynx', 'stage IVC squamous cell carcinoma of the paranasal sinus and nasal cavity', 'recurrent salivary gland cancer', 'stage III salivary gland cancer', 'stage IVA salivary gland cancer', 'stage IVB salivary gland cancer', 'stage IVC salivary gland cancer'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '24799460', 'type': 'DERIVED', 'citation': 'Argiris A, Li S, Ghebremichael M, Egloff AM, Wang L, Forastiere AA, Burtness B, Mehra R. Prognostic significance of human papillomavirus in recurrent or metastatic head and neck cancer: an analysis of Eastern Cooperative Oncology Group trials. Ann Oncol. 2014 Jul;25(7):1410-1416. doi: 10.1093/annonc/mdu167. Epub 2014 May 5.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.\n\nPURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301.', 'detailedDescription': 'OBJECTIVES:\n\n* To investigate the association between biomarkers (HPV tumor status and ERCC1 expression) and clinical outcomes in a population of patients with recurrent or metastatic head and neck cancer.\n* To develop the ability to select patients likely to respond to therapy and to avoid treatment with ineffective therapies, especially since these therapies have substantial toxicity.\n* To estimate response and survival rates of HPV-negative and -positive patients in each study. (exploratory)\n\nOUTLINE: Tumor HPV status is determined by in situ hybridization (ISH) and all samples also undergo immunostaining for p16. ERCC1 expression is evaluated with AQUA, a quantitative IHC analysis.\n\nSamples are classified into two categories based on their biomarker status: HPV tumor status (negative versus positive), and ERCC1 expression level (low versus high).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Samples from patients who participated in E1395 or E3301 and provided samples for research.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Tissue specimens from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301\n\n * Stage III, IV, or recurrent disease\n * Squamous cell disease\n * Any of the following diagnoses:\n\n * Lip and oral cavity\n * Oropharynx\n * Hypopharynx\n * Larynx\n * Paranasal sinus and nasal cavity\n * Squamous neck cancer\n * Salivary gland\n\nPATIENT CHARACTERISTICS:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT01487733', 'briefTitle': 'Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301', 'organization': {'class': 'NETWORK', 'fullName': 'Eastern Cooperative Oncology Group'}, 'officialTitle': 'Analysis of HPV and Other Biomarkers in Specimens From ECOG Studies in Recurrent or Metastatic Head and Neck Cancer (E1395 and E3301)', 'orgStudyIdInfo': {'id': 'CDR0000717143'}, 'secondaryIdInfos': [{'id': 'ECOG-E4L10T1'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'in situ hybridization', 'type': 'GENETIC'}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Athanassios Argiris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center at San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}