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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06203314
Other study ID # EBV-PRO-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2008
Est. completion date December 31, 2030

Study information

Verified date January 2024
Source Sun Yat-sen University
Contact Wei-Hua Jia
Phone 86+020-87342327
Email jiawh@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100000
Est. completion date December 31, 2030
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 69 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Diagnostic test: EBV antibody tests
Participants underwent several EBV antibody tests, including VCA-IgA, EBNA1-IgA, etc.

Locations

Country Name City State
China Wuzhou Red Cross Hospital Wuzhou Guangxi
China Zhongshan People's Hospital Zhongshan Guangdong

Sponsors (3)

Lead Sponsor Collaborator
Sun Yat-sen University Wuzhou Red Cross Hospital, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 All-cause mortality 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
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