Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

July 12, 2023 updated by: Mingfang Ji, Zhongshan People's Hospital, Guangdong, China

Searching for Early Detection Biomarkers of Nasopharyngeal Carcinoma in Zhongshan City

All participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab) et al. For all male participants and P85-Ab positive female participants, EBV DNA in plasma will be tested. Screening positive participants will be followed up annually.

All subjects will also be followed by record linkage to Cancer Register and Population Register.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sample selection

- Select communities of 20,000 to 40,000 populations in Zhongshan City and Wuzhou city as the investigators' fields.

Participants recruitment

  • Subjects voluntarily attend this screening study Informed consent - Informed consent forms will be collected at the recruitment. Questionnaires.
  • Face-to-face interviews are conducted by well-trained investigators.

Tests and follow up

  • At initial screening, all participants will be tested for EBV associated biomarkers, including EBNA1-IgA, VCA-IgA, P85-Ab et al. And in males, EBV-DNA will be tested. Based on EBNA1-IgA, VCA-IgA, participants will be stratified into high, moderate and low risk. Screening positive include P85-Ab positive, high or moderate risk of NPC or EBV DNA positive. The rest will be screening negative.
  • During the initial screening and following up, people with high risk or P85-Ab positive will refer to the diagnostic workup for NPC. Briefly, fiberoptic endoscopy and pathological biopsy will be performed by otorhinolaryngologists.
  • Screening positive people not diagnosed as nasopharyngeal carcinoma in the first year will be followed up annually.
  • EBV DNA single positive people will refer to the diagnostic workup for NPC in the third year of follow up.
  • The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital for further research.
  • All subjects will also be followed by record linkage to Cancer Register and Population Register.

Study Type

Observational

Enrollment (Estimated)

40000

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: Mingfang Ji, MD
  • Phone Number: 86-760-89880417
  • Email: jmftbh@sina.com

Study Locations

  • China
    • Guangdong
      • Zhongshan, Guangdong, China, 528403
        • Recruiting
        • Zhongshan People's Hospital
        • Contact:
        • Principal Investigator:
          • Mingfang Ji, MD
    • Guangxi
      • Wuzhou, Guangxi, China, 543002
        • Recruiting
        • Wuzhou Red Cross Hospital
        • Contact:
        • Principal Investigator:
          • Yonglin Cai, MD

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

30 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

30-69 years old healthy residences in Zhongshan City and Wuzhou City.

Description

Inclusion Criteria:

  • Subject residents in Zhongshan City or Wuzhou City
  • Subject has no medical record of nasopharyngeal carcinoma
  • ECOG 0-2
  • Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
  • Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.

Exclusion Criteria:

  • Subject has heavy cardiovascular, liver or kidney disease.
  • Subject has contraindications to nasopharyngeal fiberoptic endoscopy.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Screening cohort
30-69 years old healthy participants in Zhongshan and Wuzhou.
Biological: Blood and saliva
Collect blood and saliva samples from participants
Diagnostic test: P85-Ab, EBNA1-IgA, VCA-IgA and EBV DNA
Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants, and detect EBV DNA for all male participants and P85-Ab positive female participants.
Diagnostic test: Fiberoptic endoscopy and biopsy
Screening participants will refer to fiberoptic endoscopy and biospy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of different EBV associated biomarkers
Time Frame: 5 years
To compare the sensitivity and specificity of different EBV associated biomarkers for NPC
5 years
Positive and negative predictive values of different EBV associated biomarkers
Time Frame: 5 years
To compare the positive and negative predictive values of different EBV associated biomarkers for NPC
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number needed to screen to identify one nasopharyngeal carcinoma
Time Frame: 5 years
To compare the number of participants needed to screen identify one nasopharyngeal carcinoma for different biomarkers
5 years
Early diagnosis rate of nasopharyngeal carcinoma
Time Frame: 5 years
To compare the early diagnosis rate of different biomarkers for nasopharyngeal carcinoma
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The health economic benefits of different biomarkers for nasopharyngeal carcinoma
Time Frame: 5 years
To explore the overall survival rate, progression free survival rate and health economic benefits of NPC screening using different biomarkers
5 years
New screening strategy of nasopharyngeal carcinoma screening
Time Frame: 5 years
Comprehensive analysis of the performance of different biomarkers and their combination in the screening of nasopharyngeal carcinoma
5 years

Collaborators and Investigators

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

Sponsor

Zhongshan People's Hospital, Guangdong, China

Collaborators

Wuzhou Red Cross Hospital
Xiamen University

Investigators

  • Principal Investigator: Mingfang Ji, MD, 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)

April 1, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 9, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (Actual)

September 11, 2019

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-PRO-003

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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