NCT06203314

Brief Summary

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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Aug 2008Dec 2030

Study Start

First participant enrolled

August 1, 2008

Completed
15.4 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

16.4 years

First QC Date

December 29, 2023

Last Update Submit

January 11, 2024

Conditions

Keywords

EBVProspective studyCancer

Outcome Measures

Primary Outcomes (1)

  • Cancer incidence

    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 Outcomes (1)

  • All-cause mortality

    10 years

Study Arms (2)

Zhongshan cohort, Guangdong, China

30-59 years old healthy participants in Zhongshan city.

Other: Diagnostic test: EBV antibody tests

Wuzhou cohort, Guangxi, China

30-69 years old healthy participants in Wuzhou city.

Other: Diagnostic test: EBV antibody tests

Interventions

Participants underwent several EBV antibody tests, including VCA-IgA, EBNA1-IgA, etc.

Wuzhou cohort, Guangxi, ChinaZhongshan cohort, Guangdong, China

Eligibility Criteria

Age30 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, 543002, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma or serum

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 29, 2023

First Posted

January 12, 2024

Study Start

August 1, 2008

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2030

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

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.

Locations