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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05037357

Enrollment

370

Registered

2021-09-08

Start date

2021-08-01

Completion date

2024-06-30

Last updated

2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma, plasma EBV DNA, Harmonization

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.

Interventions

DIAGNOSTIC_TESTPlasma EBV DNA qPCR test

Peripheral blood will be collected from each subject into an EDTA tube for the isolation of plasma.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Plasma EBV DNA	1 Day	copy number of EBV DNA in plasma

Countries

China

Contacts

Primary ContactMing-Yuan Chen, MD, PhD

chmingy@mail.sysu.edu.cn86-20-8734-3361

Backup ContactSi-Yuan Chen, MD

chensy@sysucc.org.cn86-18711150216

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026