Spots Global Cancer Trial Database for Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements

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Trial Identification

Brief Title: Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements

Official Title: Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements at Multiple Centers in NPC Epidemic Regions

Study ID: NCT05037357

Conditions

Nasopharyngeal Carcinoma

Interventions

Plasma EBV DNA qPCR test

Study Description

Brief Summary: Plasma Epstein-Barr virus (EBV) DNA will be measured in native plasma samples of nasopharyngeal carcinoma (NPC) patients, respectively, by three medical centers and a qualified laboratory in Southern China, the highest endemic area of NPC. Passing-Bablok regression and difference plots will be used to compare results from each center to the all-method median and mean values. Agreement among methods will be evaluated against bias derived from a biological variation.

Detailed Description: The investigators intend to collect EBV DNA positive plasma samples of NPC patients, distribute the samples to four test centers and compare the measurement results to obtain the current status of the agreement of plasma EBV DNA measuring at different centers with various measurement systems in the endemic regions of NPC. A series of statistical analyses including Cohen's Kappa, intraclass correlation coefficient, and Passing-Bablok regression will be adopted for the consistency test. A harmonization study by using the same calibrators will be conducted.