Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-02 @ 7:45 AM
Study NCT ID:
NCT05037357
Status:
UNKNOWN
Last Update Posted:
2022-07-06
First Post:
2021-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements
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': 'Peripheral blood will be collected into ethylenediaminetetraacetic acid (EDTA)-coated tubes and centrifuged, the plasma will be recovered and frozen at -80℃ until the test.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 370}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-03', 'studyFirstSubmitDate': '2021-08-10', 'studyFirstSubmitQcDate': '2021-09-05', 'lastUpdatePostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma EBV DNA', 'timeFrame': '1 Day', 'description': 'copy number of EBV DNA in plasma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal Carcinoma', 'plasma EBV DNA', 'Harmonization'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Plasma Epstein-Barr virus (EBV) DNA will be measured in native plasma samples of nasopharyngeal carcinoma (NPC) patients, respectively, by three medical centers and a qualified laboratory in Southern China, the highest endemic area of NPC. Passing-Bablok regression and difference plots will be used to compare results from each center to the all-method median and mean values. Agreement among methods will be evaluated against bias derived from a biological variation.', 'detailedDescription': "The investigators intend to collect EBV DNA positive plasma samples of NPC patients, distribute the samples to four test centers and compare the measurement results to obtain the current status of the agreement of plasma EBV DNA measuring at different centers with various measurement systems in the endemic regions of NPC. A series of statistical analyses including Cohen's Kappa, intraclass correlation coefficient, and Passing-Bablok regression will be adopted for the consistency test. A harmonization study by using the same calibrators will be conducted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NPC patients or Plasma EBV DNA positive people', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-70 years\n* Histologically confirmed NPC or Non-NPC with positive plasma cell-free EBV DNA\n\nExclusion Criteria:\n\n* unsatisfactory performance status: Karnofsky scale (KPS) \\<= 70\n* Any severe intercurrent disease\n* Any contraindication of blood sampling'}, 'identificationModule': {'nctId': 'NCT05037357', 'briefTitle': 'Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements at Multiple Centers in NPC Epidemic Regions', 'orgStudyIdInfo': {'id': 'SYSUCC-CMY-2021-EBV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'nasopharyngeal carcinoma patients', 'description': 'Plasma EBV DNA quantification by quantitative polymerase chain reaction (qPCR) assays in different medical centers.', 'interventionNames': ['Diagnostic Test: Plasma EBV DNA qPCR test']}], 'interventions': [{'name': 'Plasma EBV DNA qPCR test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Peripheral blood will be collected from each subject into an EDTA tube for the isolation of plasma.', 'armGroupLabels': ['nasopharyngeal carcinoma patients']}]}, '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': '86-20-8734-3624'}, {'name': 'Ming-Yuan Chen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor & chief physician', 'investigatorFullName': 'Ming-Yuan Chen', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}