Epstein-Barr Virus and Cancer Risks (EBVCR)

January 11, 2024 updated by: Jia wei-hua, Sun Yat-sen University

Prospective Cohort Study on Epstein-Barr Virus Antibody and Cancer Risks

The goal of this prospective cohort study is to investigate the associations between Epstein-Barr Virus (EBV) antibody levels and the risk of overall and site-specific cancer types in Southern China. The main questions it aims to answer are:

Question 1: In addition to the established EBV-associated cancer types, such as lymphomas, nasopharyngeal carcinoma, and stomach cancer, whether EBV is associated with other cancer types? Question 2: What's the cancer burden attributed to EBV in Southern China?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Growing molecular evidence suggests the involvement of EBV in various cancers, however, comprehensive epidemiological evidence is still lacking. In this study, researchers conducted a population-based prospective cohort study to investigate the associations between EBV antibodies and the risk of overall and site-specific cancer types in Southern China. All the participants underwent EBV antibody tests at enrollment and were subsequently followed up annually for cancer incidence, vital status, and immigration status. The primary objective of this study was to provide prospective evidence for the role of EBV in multiple cancers, shedding light on the etiology of a broad range of common EBV-associated cancers.

Study Type

Observational

Enrollment (Estimated)

100000

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 Contact Backup

Study Locations

  • China
    • Guangdong
      • Zhongshan, Guangdong, China, 528403
        • Recruiting
        • Zhongshan People's Hospital
        • Contact:
        • Principal Investigator:
          • Ming-Fang Ji
    • Guangxi
      • Wuzhou, Guangxi, China, 543002
        • Recruiting
        • Wuzhou Red Cross Hospital
        • Contact:
          • Min-Zhong Tang
          • Phone Number: 86+0774-3849595
          • Email: gxtom@163.com
        • Principal Investigator:
          • Min-Zhong Tang

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

  • 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 or Wuzhou City;
  • Subject has no medical record of prevalent cancer;
  • Subject has psychical condition and well consciousness, and willingness to accept and cooperate with the study's follow-up procedures.

Exclusion Criteria:

  • Subject has heavy cardiovascular, liver, or kidney disease;
  • Subject has prevalent cancer.

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
Zhongshan cohort, Guangdong, China
30-59 years old healthy participants in Zhongshan city.
Other: Diagnostic test: EBV antibody tests
Participants underwent several EBV antibody tests, including VCA-IgA, EBNA1-IgA, etc.
Wuzhou cohort, Guangxi, China
30-69 years old healthy participants in Wuzhou city.
Other: Diagnostic test: EBV antibody tests
Participants underwent several EBV antibody tests, including VCA-IgA, EBNA1-IgA, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer incidence
Time Frame: 10 years
The primary outcome of the study was the diagnosis of any type of cancer. The cancer type for each participant was defined as their initial and primary cancer diagnosis.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 10 years
The participants were followed up annually for cancer incidence, vital status and immigration status through the Cancer Registry, Death Registry, and Population Registry of local regions.
10 years

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, 2008

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 29, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBV-PRO-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In order to prioritize and uphold participant confidentiality and privacy, we have chosen not to provide Individual Participant Data (IPD). Our commitment is to ensure the highest level of protection for the sensitive information of our participants, aligning with ethical principles and privacy regulations. This decision is made to safeguard the well-being and privacy of the individuals involved in the study.

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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