Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-22 @ 10:22 AM
Study NCT ID:
NCT02501993
Status:
UNKNOWN
Last Update Posted:
2023-07-13
First Post:
2015-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nasopharyngeal Carcinoma Screening in Zhongshan City
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum and tissue samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2015-07-13', 'studyFirstSubmitQcDate': '2015-07-15', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The early detection rate (stage I and II) of Nasopharyngeal Carcinoma', 'timeFrame': '10 years'}, {'measure': 'The mortality rate of Nasopharyngeal Carcinoma', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'The incidence of Nasopharyngeal Carcinoma', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine the early diagnosis rate and mortality rate of the Nasopharyngeal Carcinoma (NPC) in the study population.\n\nThe secondary objective is to determine the incidence of NPC in the study population.', 'detailedDescription': 'The research is to evaluate the effect of NPC screening, also as an extended study of Screening for Nasopharyngeal Carcinoma in High Risk Populations (NCT00941538).\n\nThe program was conducted in Xiaolan and Minzhong towns of Zhongshan city in 2012.\n\nAll participants will be tested for anti-EBV antibody by using serum samples. Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of Zhongshan City', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject residents in Zhongshan city\n* Subject is 30 to 59 years of age inclusive\n* Subject has no medical record of nasopharyngeal carcinoma\n* ECOG 0-2\n* Subject has psychical condition and well consciousness\n* Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.\n\nExclusion Criteria:\n\n* Subject has heavy cardiovascular, liver or kidney disease\n* Subject has medical record of nasopharyngeal carcinoma\n* Subject who is not residing in Zhongshan City'}, 'identificationModule': {'nctId': 'NCT02501993', 'briefTitle': 'Nasopharyngeal Carcinoma Screening in Zhongshan City', 'organization': {'class': 'OTHER', 'fullName': "Zhongshan People's Hospital, Guangdong, China"}, 'officialTitle': 'Serology Screening Test for the Detection of Nasopharyngeal Carcinoma in Zhongshan City', 'orgStudyIdInfo': {'id': 'NPC-PRO-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Screening cohort', 'description': 'All participants will be tested for anti-EBV antibody by using serum samples. Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '528403', 'city': 'Zhongshan', 'state': 'Guangdong', 'country': 'China', 'facility': "Zhongshan People's Hospital", 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}], 'overallOfficials': [{'name': 'Mingfang Ji, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Zhongshan People's Hospital, Guangdong, China"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zhongshan People's Hospital, Guangdong, China", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mingfang Ji', 'investigatorAffiliation': "Zhongshan People's Hospital, Guangdong, China"}}}}