Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT05447169
Status:
RECRUITING
Last Update Posted:
2022-07-08
First Post:
2022-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening
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': 'nasopharyngeal brushing and peripheral blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11625}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2030-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-06', 'studyFirstSubmitDate': '2022-07-02', 'studyFirstSubmitQcDate': '2022-07-03', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'positive predictive value', 'timeFrame': '3 years', 'description': 'the ratio of subjects truly diagnosed as nasopharyngeal carcinoma to all those who had positive test results'}, {'measure': 'negative predictive value', 'timeFrame': '3 years', 'description': 'the ratio of subjects truly diagnosed as negative (do not have nasopharyngeal carcinoma) to all those who had negative test results'}], 'secondaryOutcomes': [{'measure': 'sensitivity', 'timeFrame': '3 years', 'description': 'the percentage of subjects who test positive to those who have nasopharyngeal carcinoma'}, {'measure': 'specificity', 'timeFrame': '3 years', 'description': 'the percentage of subjects who test negative to those who do not have nasopharyngeal carcinoma'}, {'measure': 'early diagnose rate', 'timeFrame': '3 years', 'description': 'the ratio of patients with stage I and stage II disease to all those who have nasopharyngeal carcinoma'}, {'measure': 'cost-effectiveness', 'timeFrame': '3 years', 'description': 'the cost of detecting one nasopharyngeal carcinoma case'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal Carcinoma Screen', 'EBV DNA', 'EBV antibody'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'The investigators intend to compare Epstein-Barr virus antibody and Epstein-Barr virus DNA screening efficacy in first-degree relatives of nasopharyngeal carcinoma patients.', 'detailedDescription': 'The investigators intend to test Epstein-Barr virus antibodies (Viral Capsid Antigen-immunoglobulin A， Epstein-Barr nuclear antigen 1-immunoglobulin A， early antigen-immunoglobulin A， Zta-immunoglobulin A， Rta-immunoglobulin G, Bnlf 2b) by ELISA and Epstein-Barr virus DNA by quantitative polymerase chain reaction, target sequencing and CRISPR-associated protein 12a in nasopharyngeal brushing and plasma of the same population at high-risk of nasopharyngeal carcinoma so as to determine the best method in nasopharyngeal carcinoma screening.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residences in Southern China', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residents in Southern China\n* 30-62 years old\n* male\n* a first-degree relative of at least one nasopharyngeal carcinoma patient\n* no medical record of nasopharyngeal carcinoma\n* Eastern Cooperative Oncology Group score of 0-2\n* be able to comprehend, sign, and date the written informed consent document to participate in the study\n\nExclusion Criteria:\n\n* history of nasopharyngeal carcinoma\n* heavy cardiovascular, liver or kidney disease\n* on systemic steroid or immunosuppressant treatment or active autoimmune disease'}, 'identificationModule': {'nctId': 'NCT05447169', 'briefTitle': 'Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Parallel Controlled Study of Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening in the High-risk Population', 'orgStudyIdInfo': {'id': 'SYSUCC-CMY-2022-screen'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High risk population of nasopharyngeal carcinoma', 'description': 'first-degree relatives of nasopharyngeal carcinoma patients, aged 30-62 male', 'interventionNames': ['Diagnostic Test: EBV antibodies test', 'Diagnostic Test: EBV DNA test']}], 'interventions': [{'name': 'EBV antibodies test', 'type': 'DIAGNOSTIC_TEST', 'description': 'ELISA test of VCA-IgA，EBNA1-IgA，EA-IgA， Zta-IgA ，Rta-IgG and BNLF 2b in nasopharyngeal brushing and plasma', 'armGroupLabels': ['High risk population of nasopharyngeal carcinoma']}, {'name': 'EBV DNA test', 'type': 'DIAGNOSTIC_TEST', 'description': 'quantitative polymerase chain reaction, CRISPR-associated protein 12a and target sequencing of EBV DNA in nasopharyngeal brushing and plasma', 'armGroupLabels': ['High risk population of nasopharyngeal carcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming-Yuan Chen, MD,PhD', 'role': 'CONTACT', 'email': 'chmingy@mail.sysu.edu.cn', 'phone': '86-20-8734-2422'}], 'facility': 'Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Ming-Yuan Chen, MD, PhD', 'role': 'CONTACT', 'email': 'chmingy@mail.sysu.edu.cn', 'phone': '86-20-8734-3361'}, {'name': 'Si-Yuan Chen, MD', 'role': 'CONTACT', 'email': 'chensy@sysucc.org.cn', 'phone': '86-18711150216'}], 'overallOfficials': [{'name': 'Ming-Yuan Chen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wuzhou Red Cross Hospital', 'class': 'OTHER'}, {'name': "Zhongshan People's Hospital, Guangdong, China", 'class': 'OTHER'}, {'name': 'Hunan Cancer Hospital', 'class': 'OTHER'}, {'name': 'The Third Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, {'name': "First People's Hospital of Foshan", 'class': 'OTHER'}, {'name': "Yuebei People's Hospital", 'class': 'OTHER'}, {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, {'name': 'Changsha Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor & chief physician', 'investigatorFullName': 'Ming-Yuan Chen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}