Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements

July 3, 2022 updated by: Ming-Yuan Chen, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

NPC patients or Plasma EBV DNA positive people

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
nasopharyngeal carcinoma patients
Plasma EBV DNA quantification by quantitative polymerase chain reaction (qPCR) assays in different medical centers.
Diagnostic test: Plasma EBV DNA qPCR test
Peripheral blood will be collected from each subject into an EDTA tube for the isolation of plasma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma EBV DNA
Time Frame: 1 Day
copy number of EBV DNA in plasma
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Wuzhou Red Cross Hospital
Zhongshan People's Hospital, Guangdong, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

September 5, 2021

First Posted (Actual)

September 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 3, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-CMY-2021-EBV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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