Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-01-04 @ 4:40 AM
Study NCT ID:
NCT02879968
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2016-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Squamous Cell Carcinoma Antigen Level and Tumor Volume in Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum squamous cell carcinoma antigen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2016-08-23', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between serum squamous cell carcinoma antigen and tumor volume', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['serum squamous cell carcinoma antigen', 'tumor volume', 'Head and Neck Cancer'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'Correlation between serum squamous cell carcinoma antigen level and tumor volume in Head and Neck Cancer is to determine a correlation between level of serum squamous cell carcinoma antigen and tumor volume in Head and Neck Caner measured by cross-sectional imaging.', 'detailedDescription': 'The study is a cross-sectional study. A single measurement of serum squamous cell carcinoma antigen level is performed in the eligible Head and Neck squamous cell carcinoma patients.\n\nThe study tool measuring serum squamous cell carcinoma antigen level is ARCHITECT SCC (Abbott).\n\nThe gross tumor volume in the cross sectional imaging obtained within 2 weeks of each patient is calculated with the typical ellipsoid formula.\n\nCorrelation between both parameters will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Head and Neck squamous cell carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven squamous cell carcinoma in Head and Neck\n* Getting a cross-sectional imaging of Head and Neck within 2 weeks of collecting serum squamous cell carcinoma antigen\n\nExclusion Criteria:\n\n* Metastatic disease\n* Accompanied Non-Head and Neck squamous cell carcinoma\n* Nasopharyngeal, thyroid, salivary, nose and paranasal sinus carcinoma\n* Skin disease: eczema, erythrodermic epidermitis, pemphigus, and psoriasis\n* Pulmonary disease: tuberculosis, adult respiratory distress syndrome, pulmonary infiltration with eosinophilia, sarcoidosis, and bronchogenic cyst\n* Renal failure\n* Using antihistamine eye drops'}, 'identificationModule': {'nctId': 'NCT02879968', 'briefTitle': 'Serum Squamous Cell Carcinoma Antigen Level and Tumor Volume in Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'Correlation Between Serum Squamous Cell Carcinoma Antigen Level and Tumor Volume in Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'PrinceSongklaU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Head and Neck squamous cell carcinoma', 'description': 'A single measurement of serum squamous cell carcinoma antigen level is performed in the eligible Head and Neck squamous cell carcinoma patients.\n\nThe study tool measuring serum squamous cell carcinoma antigen level is ARCHITECT SCC (Abbott).\n\nThe gross tumor volume in the cross sectional imaging obtained within 2 weeks of each patient is calculated with the typical ellipsoid formula.', 'interventionNames': ['Other: Non-interventional study']}], 'interventions': [{'name': 'Non-interventional study', 'type': 'OTHER', 'armGroupLabels': ['Head and Neck squamous cell carcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hadyai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Prince of Songkla University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kitti Jantharapattana, M.D.', 'investigatorAffiliation': 'Prince of Songkla University'}}}}