Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-01 @ 8:02 AM
Study NCT ID:
NCT03087695
Status:
UNKNOWN
Last Update Posted:
2017-03-22
First Post:
2017-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma
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': 'The patients will be collected blood sample once per week during chemoradiotherapy period. Plasma will be extracted from these blood sample. Plasma EBV DNA concentrations will be measured by a real-time quantitative polymerase chain reaction.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2019-01-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-16', 'studyFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2017-03-16', 'lastUpdatePostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '2 years', 'description': 'Survival calculation'}], 'secondaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': '2 years', 'description': 'Survival calculation'}, {'measure': 'Nasopharynx failure-free survival (NPFFS)', 'timeFrame': '2 years', 'description': 'Survival calculation'}, {'measure': 'Neck failure-free survival (NFFS)', 'timeFrame': '2 years', 'description': 'Survival calculation'}, {'measure': 'Distant metastasis failure-free survival (DMFFS)', 'timeFrame': '2 years', 'description': 'Survival calculation'}, {'measure': 'Tumor response', 'timeFrame': '2 years', 'description': 'Tumor response evaluated by image'}, {'measure': 'EBV DNA concentration', 'timeFrame': '2 years', 'description': 'Plasma EBV DNA by real-time polymerase chain reaction (PCR)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasopharyngeal carcinoma', 'EBV DNA', 'Chemoradiotherapy'], 'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Epstein-Barr virus (EBV) has been proven to process a strong association in patient of nasopharyngeal carcinoma (NPC). Monitoring plasma EBV DNA in NPC patients can provide reliable informations in early detecting tumor recurrence or risk grouping.', 'detailedDescription': "EBV DNA has strongly association in NPC patient' disease status. It can provide informations of disease relapse or risks classification. In this study, we will investigate the impact of plasma EBV DNA concentration change during chemoradiotherapy on initial tumor response and long-term survival in patients with advanced nasopharyngeal carcinoma"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Nasopharyngeal carcinoma patient received definite treatment in Taichung Veteran General Hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histological proven NPC.\n2. 2010 American Joint Committee on Cancer (AJCC) stage II-IVB.\n3. Age ≧ 20 years old.\n4. Performance status of Eastern Cooperative Oncology Group (ECOG) ≦ 2.\n5. Adequate liver, renal, and bone marrow functions 5.1 Serum total bilirubin level ≦ 2.5 mg/dl. 5.2 Serum creatinine ≦ 1.6 mg/dl or calculated creatinine clearance rate (CCr) ≧ 60 cc/min.\n\n 5.3 White blood cell count (WBC) ≧ 3,000/micro-ml. 5.4 Platelet count ≧ 100,000/micro-ml.\n6. Pre-treatment plasma EBV DNA \\> 0 copies/mL\n7. Signed informed consent.\n\nExclusion Criteria:\n\n1. Presence of distant metastasis.\n2. Previous radiotherapy or chemotherapy.\n3. History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast.\n4. Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.\n5. Female patients who are pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT03087695', 'briefTitle': 'Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'Effect of the Plasma EBV DNA Concentration Change During Chemoradiotherapy on Tumor Control and Patient Survival in Advanced Nasopharyngeal Carcinoma', 'orgStudyIdInfo': {'id': 'CF17002B'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Plasma EBV DNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Parameters analyzed will include (1) the change pattern of plasma EBV DNA concentrations, (2) various half-life values (t1/2) of plasma EBV DNA clearance rate calculated over different time periods.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40705', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jin-Ching Lin, MD, PhD', 'role': 'CONTACT', 'email': 'jclin@vghtc.gov.tw', 'phone': '+886-4-23592525', 'phoneExt': '5613'}, {'name': 'Yi-Chun Liu, MD', 'role': 'CONTACT', 'email': 'b9202080@gmil.com', 'phone': '+886-4-23592525', 'phoneExt': '5621'}], 'facility': 'Taichung Veteran General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Jin-Ching Lin, MD, PhD', 'role': 'CONTACT', 'email': 'jclin@vghtc.gov.tw', 'phone': '+886-4-23592525', 'phoneExt': '5613'}, {'name': 'Yi-Chun Liu, MD', 'role': 'CONTACT', 'email': 'b9202080@gmail.com', 'phone': '+886-4-23592525', 'phoneExt': '5621'}], 'overallOfficials': [{'name': 'Jin-Ching Lin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taichung Veterans General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to make individual participant data (IPD) available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}