Serial Epstein-Barr Virus DNA Surveillance in Nasopharyngeal Carcinoma Patients

Sun Yat-sen University1,000 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Nasopharyngeal Carcinoma

Interventions

Plasma EBV DNADIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type) 2. No evidence of distant metastasis (M0) 3. Receive standard radical treatment 4. Not exhibiting overt psychopathology, and willing to participate and written informed consent was obtained Exclusion Criteria: 1. WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. 2. Treatment with palliative intent 3. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) 4. Severe intercurrent disease

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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.

Time frame: 3 years

Secondary Outcomes

overall survival

Overall survival is calculated from the date of diagnosis of NPC to the date of death from any cause

Time frame: 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.

Time frame: 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.

Time frame: 3 years

EBV DNA clearance rate

The half-life value (t1/2) of plasma EBV DNA clearance was calculated using the equation of \[t1/2 = 0.693/k\].

Time frame: during the first month

Data from ClinicalTrials.gov

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