Verification of Harmonization of Plasma Epstein-Barr Virus DNA Measurements
1 other identifier
observational
370
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 10, 2021
CompletedFirst Posted
Study publicly available on registry
September 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedJuly 6, 2022
July 1, 2022
1.3 years
August 10, 2021
July 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma EBV DNA
copy number of EBV DNA in plasma
1 Day
Study Arms (1)
nasopharyngeal carcinoma patients
Plasma EBV DNA quantification by quantitative polymerase chain reaction (qPCR) assays in different medical centers.
Interventions
Peripheral blood will be collected from each subject into an EDTA tube for the isolation of plasma.
Eligibility Criteria
NPC patients or Plasma EBV DNA positive people
You may qualify if:
- Age between 18-70 years
- Histologically confirmed NPC or Non-NPC with positive plasma cell-free EBV DNA
You may not qualify if:
- unsatisfactory performance status: Karnofsky scale (KPS) \<= 70
- Any severe intercurrent disease
- Any contraindication of blood sampling
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sun Yat-sen Universitylead
- Wuzhou Red Cross Hospitalcollaborator
- Zhongshan People's Hospital, Guangdong, Chinacollaborator
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Biospecimen
Peripheral blood will be collected into ethylenediaminetetraacetic acid (EDTA)-coated tubes and centrifuged, the plasma will be recovered and frozen at -80℃ until the test.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ming-Yuan Chen, MD, PhD
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor & chief physician
Study Record Dates
First Submitted
August 10, 2021
First Posted
September 8, 2021
Study Start
August 1, 2021
Primary Completion
December 1, 2022
Study Completion
June 1, 2024
Last Updated
July 6, 2022
Record last verified: 2022-07