[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540830":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":38,"studyPopulation":39,"armGroups":34,"interventions":40,"overallOfficials":34,"centralContacts":44,"locations":50,"responsibleParty":68,"collaborators":34,"id":71,"slug":34,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":34,"eligibilityCriteria":75,"healthyVolunteers":72,"sex":76,"minAge":77,"maxAge":34,"enrollmentInfo":78,"targetDuration":34,"studyType":81,"phases":34,"briefSummary":38,"conditions":82,"keywords":34,"overallStatus":53,"whyStopped":34,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Hunan Cancer Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Positivity rate of plasma EpsteineBarr virus (EBV) DNA by next generation sequencing","Plasma EBV DNA analysis by NGS on enrollment, after 2 cycles of induction chemotherapy, and 4-8 weeks after definitive radiotherapy.","from diagnose to 4-8 weeks after definitive radiotherapy",[14,18,21,24,27,31],{"measure":15,"description":16,"timeFrame":17},"Overall survival","Measured from the day of enrollment until death due to any cause, or the last follow-upmeasured from the day of enrollment until death due to any cause, or the last follow-up visit.","2 year",{"measure":19,"description":20,"timeFrame":17},"Distant metastasis failure-free survival","Measured from the day of enrollment until death until distant metastasis , or the last follow-up visit.",{"measure":22,"description":23,"timeFrame":17},"Locoregional failure-free survival","Measured from the day of enrollment until death until local and\u002For regional recurrence, or the last follow-up visit.",{"measure":25,"description":26,"timeFrame":17},"Failure-free survival","Measured from the day of enrollment until treatment failure, death from any cause, or the last follow-up visit, whichever occurred first.",{"measure":28,"description":29,"timeFrame":30},"Patient reported quality-of-life score","Patient reported quality of life would be evaluated using the Quality of Life Questionnaire-Core 30 module (QLQ-C30).","up to 2 years",{"measure":32,"description":33,"timeFrame":12},"Biomarker analysis","Exploratory biomarker analysis that would be able to predict patient treatment benefits, for example PD-L1 expression, antigen (other than EBV, eg. human cytomegalovirus(human cytomegalovirus \\[HCMV\\], TTV) DNA counting.",null,{"allocation":34,"interventionModel":34,"interventionModelDescription":34,"primaryPurpose":34,"observationalModel":36,"timePerspective":37,"maskingInfo":34},"COHORT","PROSPECTIVE","The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future.","Non-metastatic NPC",[41],{"type":42,"name":43,"description":43,"armGroupLabels":34,"otherNames":34},"DIAGNOSTIC_TEST","EBV-DNA next generation sequencing",[45],{"name":46,"role":47,"phone":48,"phoneExt":34,"email":49},"Yaqian Han","CONTACT","(+86)18673176667","hanyaqian@hnca.org.cn",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":34,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Hunan cancer Hospital","RECRUITING","Changsha","Hunan","China","CN",{"type":59,"coordinates":60},"Point",[61,62],112.97087,28.19874,{"lat":62,"lon":61},[65],{"name":46,"role":47,"phone":66,"phoneExt":34,"email":67},"+8618673176667","hanyaqiancs@163.com",{"type":69,"investigatorFullName":46,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Professor","100540830",false,"NCT06321939","Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Newly diagnosed, pathologically proven World Health Organization (WHO) type II\u002FIII untreated NPC;\n2. Non-metastatic NPC (I-IVA, according to the 8th edition of the AJCC\u002FUICC clinical staging system);\n3. Age at diagnosis: over 18 years old;\n4. Eastern Cooperative Oncology Group (ECOG) score: 0-1\n5. Receiving recommended curative intention treatments：definitive radiotherapy w\u002Fwo three cycles of induction chemotherapy (IC) (gemcitabine-cisplatin \\[GP\\] or paclitaxel-cisplatin \\[TP\\] regimen);\n6. Pre-treatment and post-IC1 cell-free Epstein-Barr virus (cfEBV) DNA \\> 0 copy\u002FmL; systemic cfEBV DNA monitoring during IC phase for risk stratification;\n7. Normal hematic, liver, and kidney function: hemoglobin (HG) \\> 90 g\u002FL; neutrophil \\> 1.5 × 109\u002FL; platelet \\> 100 × 109\u002FL; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN; creatinine clearance (Ccr) ≥ 60 mL\u002Fmin;\n8. Female subjects capable of becoming pregnant agree to use reliable contraceptive measures from screening to 1 year after treatment;\n9. Patients will be required to sign informed consent forms and be willing and able to comply with the requirements for visits, treatment, laboratory tests, and other research requirements stipulated in the research schedule.\n\nExclusion Criteria:\n\n1. Receiving surgery, target therapy, and\u002For immunotherapy during or before induction phase;\n2. Other previous or concurrent malignant tumors, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, and thyroid papillary cancer;\n3. Pregnant or lactating women (a pregnancy test should be considered for fertile women with an active sex life);\n4. Previously treated with radical radiotherapy (RT), except non-melanoma skin cancers outside intended RT treatment volume;\n5. Uncontrolled heart disease, e.g.: 1) Heart failure, New York Heart Association (NYHA) level ≥ 2; 2) unstable angina; 3) myocardial infarction in the past 1 year; 4) supraventricular or ventricular arrhythmia requiring treatment or intervention.","ALL","18 Years",{"count":79,"type":80},50,"ESTIMATED","OBSERVATIONAL",[83,84],"Nasopharyngeal Carcinoma","Herpesvirus 4, Human","2024-03-14",{"date":87,"type":88},"2024-03-20","ACTUAL",{"date":90,"type":88},"2024-01-11",{"date":92,"type":80},"2028-12-31",{"name":5,"class":6},1]