Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients

Study Overview
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Brief Summary
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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

Official Title
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Serial Epstein-Barr Virus DNA Surveillance During Treatment in Non-metastatic Nasopharyngeal Carcinoma Patients

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Diagnostic Test: Plasma EBV DNA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type) No evidence of distant metastasis (M0) Receive standard radical treatment Not exhibiting overt psychopathology, and willing to participate and written informed consent was obtained Exclusion Criteria: WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. Treatment with palliative intent Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) Severe intercurrent disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| observational cohort<br>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. | Diagnostic Test: Plasma EBV DNA<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | Overall survival is calculated from the date of diagnosis of NPC to the date of death from any cause | 3 years | 
| Distant metastasis-free survival | 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. | 3 years | 
| locoregional failure-free survival | 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. | 3 years | 
| EBV DNA clearance rate | The half-life value (t1/2) of plasma EBV DNA clearance was calculated using the equation of [t1/2 = 0.693/k]. | during the first month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plasma EBV DNA, nasopharyngeal carcinoma, longitudinal surveillance