Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT00186433
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D008048', 'term': 'Lip Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008047', 'term': 'Lip Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-22', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Epstein-Bar Virus (EBV) DNA concentrations', 'timeFrame': 'every 6 months until end of study', 'description': 'measured by quantitative polymerase chain reaction (PCR)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mouth Cancer', 'Lip Cancer', 'Throat Cancer', 'Lip Neoplasms', 'Head and Neck Cancers']}, 'referencesModule': {'references': [{'pmid': '23459720', 'type': 'DERIVED', 'citation': 'Le QT, Zhang Q, Cao H, Cheng AJ, Pinsky BA, Hong RL, Chang JT, Wang CW, Tsao KC, Lo YD, Lee N, Ang KK, Chan AT, Chan KC. An international collaboration to harmonize the quantitative plasma Epstein-Barr virus DNA assay for future biomarker-guided trials in nasopharyngeal carcinoma. Clin Cancer Res. 2013 Apr 15;19(8):2208-15. doi: 10.1158/1078-0432.CCR-12-3702. Epub 2013 Mar 4.'}]}, 'descriptionModule': {'briefSummary': '1. To determine the prognostic implication of plasma Epstein-Bar Virus (EBV) DNA concentrations, as measured by quantitative polymerase chain reaction (PCR) in patients with nasopharyngeal carcinoma (NPC).\n2. To relate pretreatment plasma EBV DNA concentration to WHO classification of these tumors both in endemic and non-endemic areas.\n3. To determine whether pretreatment plasma EBV DNA can serve as a prognostic factor for both endemic and non-endemic patient populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Having a new diagnosis of Nasopharyngeal carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a new diagnosis of Nasopharyngeal carcinoma.\n* Being treated with either radiotherapy or chemoradiotherapy for this condition.\n\nExclusion Criteria:\n\n* Age \\<18 since NPC is a very rare condition in this age group and may have a different biological behavior\n* Patients who are unable to provide informed consents for themselves.'}, 'identificationModule': {'nctId': 'NCT00186433', 'briefTitle': 'A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Longitudinal Study of Plasma EBV DNA in Nasopharyngeal Carcinoma From Both Endemic and Non-Endemic Patient Populations', 'orgStudyIdInfo': {'id': 'ENT0006'}, 'secondaryIdInfos': [{'id': 'ENT0006', 'type': 'OTHER', 'domain': 'Stanford University'}, {'id': '77622', 'type': 'OTHER', 'domain': 'Stanford University Alternate IRB Approval Number'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Quynh-Thu Le', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Katharine Dexter McCormick and Stanley McCormick Memorial Professor', 'investigatorFullName': 'Quynh-Thu Le', 'investigatorAffiliation': 'Stanford University'}}}}