Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Diagnostic Test: Plasma EBV DNA qPCR test

• Registration Number: NCT05037357
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-09-05
• Study First Posted: 2021-09-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-03
• Last Update Posted: 2022-07-06
• Primary Completion: 2022-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

• Age between 18-70 years
• Histologically confirmed NPC or Non-NPC with positive plasma cell-free EBV DNA

Exclusion Criteria

• unsatisfactory performance status: Karnofsky scale (KPS) <= 70
• Any severe intercurrent disease
• Any contraindication of blood sampling

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
nasopharyngeal carcinoma patients	Plasma EBV DNA qPCR test	Plasma EBV DNA quantification by quantitative polymerase chain reaction (qPCR) assays in different medical centers.

Primary Outcome Measures

Name	Time	Method
Plasma EBV DNA	1 Day	copy number of EBV DNA in plasma

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China