Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-03-11 @ 7:36 AM
Study NCT ID:
NCT03314051
Status:
COMPLETED
Last Update Posted:
2017-10-20
First Post:
2017-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Treatment Outcome for Stage III NPC Patients and Risk Grouping by Plasma EBV DNA
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': 'We collected the pre-treatment and post-treatment plasma EBV DNA. The plasma EBV DNA assay was analyzed by real time PCR.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 366}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-18', 'studyFirstSubmitDate': '2017-10-15', 'studyFirstSubmitQcDate': '2017-10-15', 'lastUpdatePostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '5 year', 'description': 'Diagnosis to death'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '5 year', 'description': 'Diagnosis to death to recurrence or metastasis'}, {'measure': 'Distant metastasis failure-free survival (DMFFS)', 'timeFrame': '5 year', 'description': 'Diagnosis to death to distant metastasis'}, {'measure': 'Locoregional failure-free survival (LRFFS)', 'timeFrame': '5 year', 'description': 'Diagnosis to death to locoregional failure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal Carcinoma', 'plasma EBV DNA'], 'conditions': ['Nasopharyngeal Carcinoma', 'EBV Related Carcinoma']}, 'descriptionModule': {'briefSummary': 'No previous study reported the treatment outcome of stage III nasopharyngeal carcinoma (NPC) patients. The investigators try to investigate the long-term treatment outcome of stage III NPC patients and do risk grouping by plasma Epstein-Barr virus (EBV) DNA assay for future therapy improvement.', 'detailedDescription': 'The stage III NPC patients were the majority group of the patient population of NPC. But most clinical trials focused on the treatment of American Joint Committee on Cancer (AJCC) 7th edition stage IVA/IVB treatment for high risk of recurrence or metastasis. No previous study reported the treatment outcome of stage III NPC patients. The investigators tried to investigate the long-term treatment outcome of stage III NPC patients and do risk grouping by plasma EBV DNA assay for future therapy improvement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Tissue proven stage III NPC patients and received curative treatment in our institute. Pre-treatment and post-radiotherapy plasma EBV DNA will be obtained.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy-proven stage III nasopharyngeal carcinoma (NPC)\n* Finished curative chemoradiotherapy\n* Have Pre-treatment and post-radiotherapy plasma EBV DNA\n\nExclusion Criteria:\n\n* No tissue proven NPC\n* Not finished curative treatment\n* No Pre-treatment and post- radiotherapy plasma EBV DNA'}, 'identificationModule': {'nctId': 'NCT03314051', 'briefTitle': 'Long-term Treatment Outcome for Stage III NPC Patients and Risk Grouping by Plasma EBV DNA', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'Long-term Treatment Outcome for Stage III Nasopharyngeal Carcinoma Patients and Risk Grouping by Plasma Epstein-Barr Virus DNA', 'orgStudyIdInfo': {'id': 'CE12117'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jin-Ching Lin, MD.PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, Taichung Veterans General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}