Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT03855020
Status:
UNKNOWN
Last Update Posted:
2023-06-18
First Post:
2019-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-16', 'studyFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2019-02-23', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '3 years', 'description': 'Progression-free survival is calculated from the date of diagnosis of NPC to the date of progression of NPC or the date of death from any cause, whichever comes earlier.'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '3 years', 'description': 'Overall survival is calculated from the date of diagnosis of NPC to the date of death from any cause'}, {'measure': 'Distant metastasis-free survival', 'timeFrame': '3 years', 'description': 'Distant metastasis-free survival is calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier.'}, {'measure': 'locoregional failure-free survival', 'timeFrame': '3 years', 'description': 'Local or regional failure-free survival is calculated from the date of diagnosis of NPC to the date of regional nodal failure or date of death from any cause, whichever comes earlier.'}, {'measure': 'EBV DNA clearance rate', 'timeFrame': 'during the first month', 'description': 'The half-life value (t1/2) of plasma EBV DNA clearance was calculated using the equation of \\[t1/2 = 0.693/k\\].'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['plasma EBV DNA', 'nasopharyngeal carcinoma', 'longitudinal surveillance'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Endemic nasopharyngeal carcinoma (NPC) is invariably associated with Epstein-barr virus (EBV) infection. Plasma EBV DAN detected by polymerase chain reaction (PCR)-based assays can provide important informations of disease screening, disease relapse, and risks classification. In this study, the investigators will explore the impact of serial plasma EBV DNA during chemotherapy and radiotherapy on initial tumor response and long-term survival in patients with non-metastatic nasopharyngeal carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with histologically confirmed, non-metastatic, previously untreated nasopharyngeal carcinoma (NPC) will be invited to join this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)\n2. No evidence of distant metastasis (M0)\n3. Receive standard radical treatment\n4. Not exhibiting overt psychopathology, and willing to participate and written informed consent was obtained\n\nExclusion Criteria:\n\n1. WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.\n2. Treatment with palliative intent\n3. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)\n4. Severe intercurrent disease'}, 'identificationModule': {'nctId': 'NCT03855020', 'briefTitle': 'Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Serial Epstein-Barr Virus DNA Surveillance During Treatment in Non-metastatic Nasopharyngeal Carcinoma Patients', 'orgStudyIdInfo': {'id': '2019-FXY-015-radiation'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'observational cohort', 'description': 'Patients enrolled in this observational cohort would have regular blood taking for EBV DNA examination at baseline, after every cycle of chemotherapy, every week during radiotherapy, and 1-3 months after chemo-radiotherapy until EBV DNA becomes undetectable for at least two times.', 'interventionNames': ['Diagnostic Test: Plasma EBV DNA']}], 'interventions': [{'name': 'Plasma EBV DNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Parameters analyzed will include (1) the changing pattern of plasma EBV DNA concentrations during chemotherapy and radiotherapy (2) half-life values (t1/2) of plasma EBV DNA clearance rate', 'armGroupLabels': ['observational cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not to share individual participant data (IPD) available to other researchers unless reasonably required, and only the PI has the whole access to the complete data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice-president', 'investigatorFullName': 'Ying Sun', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}