NCT05037357

Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 370 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Plasma EBV DNA qPCR test	Peripheral blood will be collected from each subject into an EDTA tube for the isolation of plasma.

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-12-01
• Completion: 2024-06-01
• First posted: 2021-09-08
• Last updated: 2022-07-06

Locations

1 site across 1 country: China