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NCT05037357 Clinical Trial

Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05037357
Other study ID # SYSUCC-CMY-2021-EBV
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date June 2024

Study information
Verified date July 2022
Source Sun Yat-sen University
Contact Ming-Yuan Chen, MD, PhD
Phone 86-20-8734-3361
Email chmingy@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 370
Est. completion date June 2024
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Plasma EBV DNA qPCR test
Peripheral blood will be collected from each subject into an EDTA tube for the isolation of plasma.

Locations
Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong

Sponsors (3)
Lead Sponsor Collaborator
Sun Yat-sen University Wuzhou Red Cross Hospital, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma EBV DNA copy number of EBV DNA in plasma 1 Day
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