Viewing Study NCT01171235


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Study NCT ID: NCT01171235
Status: UNKNOWN
Last Update Posted: 2010-07-28
First Post: 2010-07-27
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Study of Biomarker From Blood and Tissue of Head and Neck Carcinoma
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007822', 'term': 'Laryngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}], 'ancestors': [{'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood and tissue samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-27', 'studyFirstSubmitDate': '2010-07-27', 'studyFirstSubmitQcDate': '2010-07-27', 'lastUpdatePostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Laryngeal Neoplasms', 'Pharyngeal Neoplasms'], 'conditions': ['Laryngeal Neoplasms', 'Pharyngeal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '24481647', 'type': 'DERIVED', 'citation': 'Yu BL, Peng XH, Zhao FP, Liu X, Lu J, Wang L, Li G, Chen HH, Li XP. MicroRNA-378 functions as an onco-miR in nasopharyngeal carcinoma by repressing TOB2 expression. Int J Oncol. 2014 Apr;44(4):1215-22. doi: 10.3892/ijo.2014.2283. Epub 2014 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to find for one or more serum or tissue markers of molecular biology in head and neck cancer patients used for early diagnosis, predicting prognosis and being sensitive to chemotherapy and radiotherapy', 'detailedDescription': 'Head and neck malignant tumors, especially nasopharyngeal carcinoma in southern China with the high incidence, its incidence, treatment, prognosis or tumor markers in serum has been a hot research with little progress.In our study, we collect NPC-based collection including the blood samples of laryngeal, hypopharyngeal cancer, separating serum and white blood cells stored in -80 degrees,while tissues are frozen in liquid nitrogen and embedded in paraffin。 Patient treatment and prognosis are combined in order to find for markers of molecular biology used for early diagnosis, predicting prognosis and being sensitive to chemotherapy and radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all of nasopharyngeal carcinoma, hypopharyngeal carcinoma or laryngeal carcinoma visited at ENT department of NanFang hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all of nasopharyngeal carcinoma\n* hypopharyngeal carcinoma or laryngeal carcinoma visited at ENT department of NanFang hospital\n\nExclusion Criteria:\n\n* all of above patients whose anticipated survival duration were less than 6 months'}, 'identificationModule': {'nctId': 'NCT01171235', 'briefTitle': 'Study of Biomarker From Blood and Tissue of Head and Neck Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Southern Medical University, China'}, 'officialTitle': 'Study of Previously Collected Blood and Tissue Samples From Patients With Nasopharyngeal Carcinoma,Laryngeal Carcinoma and Hypopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'NFYY-H&N-1'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ping Xiang Li, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'E.N.T department of NanFang hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'E.N.T department of Nan Fang Hospital, Nan Fang Medical University', 'oldOrganization': 'China: National Natural Science Foundation'}}}}