- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05037357
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
- Name: Si-Yuan Chen, MD
- Phone Number: 86-18711150216
- Email: chensy@sysucc.org.cn
Study Locations
-
-
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
16 years to 68 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.
|
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
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
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- DNA Virus Infections
- Tumor Virus Infections
- Herpesviridae Infections
- Nasopharyngeal Neoplasms
- Nasopharyngeal Carcinoma
- Epstein-Barr Virus Infections
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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