"Xijiang Project" Screening Cohort for NPC

January 16, 2025 updated by: Ming-Yuan Chen

Establishment of "Xijiang Project" Million-Person Screening Cohort for Nasopharyngeal Carcinoma

The purpose of this study is to establish a comprehensive and integrated nasopharyngeal carcinoma screening cohort, which includes an epidemiological information database containing basic information, gender, age, ethnic and family history, dietary and lifestyle habits, and geographical environmental factors; a biobank of blood, tissue fluid, swabs, etc., for Epstein-Barr virus, tumors, and genetics; a clinical examination database including nasopharyngoscopy, imaging, pathology, and other examinations; and databases of Epstein-Barr virus and human genetic sequencing, etc.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to initiate a multicenter prospective nasopharyngeal carcinoma (NPC) screening cohort study around China, starting from regions with high incidence of NPC, to conduct a million-person-scale screening cohort study. Participants who meet the selection criteria will be included in the cohort. All participants will undergo an epidemiological information survey (including basic conditions, dietary and lifestyle habits, social, geographical, environmental, and other information) through questionnaires, and various samples such as blood, tissue fluid, and throat swabs will be collected. Quantitative testing or genetic sequencing will be conducted on Epstein-Barr virus (EBV) (including EBV-related proteins, antibodies, EBV DNA quantification and sequence length, methylation levels, and next-generation sequencing), nasopharyngeal epithelial or tumor cells, etc., to establish, validate, optimize, and promote the optimal combination screening strategy for NPC; participants defined as high-risk of NPC by screening will undergo clinical nasopharyngoscopy and combined imaging and pathological examinations to confirm NPC patients and provide them with precise clinical treatment; regular follow-ups of the entire cohort will be conducted to study the risk factors and molecular mechanisms of NPC. The purpose of this study is to establish a comprehensive and integrated data platform, primarily based on the population from the South China, including an NPC epidemiological information database based on the gender, age, ethnicity, dietary and lifestyle habits, and geographical environmental factors, a biobank based on various samples and screening test results, and a clinical examination database based on nasopharyngoscopy, head and neck MRI, and a database for EB virus and human genetic sequencing information, etc., forming a multi-source heterogeneous, open, and shared data platform. Based on this data platform, basic scientific and clinical research on NPC will be conducted, including: developing, validating, and optimizing new NPC screening markers and their composite screening programs, clarifying the target population for the promotion of NPC composite screening programs; research study of the etiology and risk factors of NPC from genetic, ethnic, geographical, environmental, and lifestyle aspects, proposing a dynamic evolutionary molecular theory of NPC occurrence and development; exploring NPC prevention measures through lifestyle changes, vaccination interventions, and other methods; exploring new de-escalation clinical treatment plans for NPC, constructing new strategies for precise prevention and treatment of NPC such as minimally invasive surgical treatment and de-escalation of chemoradiotherapy, etc.

Study Type

Observational

Enrollment (Estimated)

1000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China, 519000
        • The Fifth Affiliated Hospital of Sun Yat-sen University

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

Residents with a definite native place, aged 30 and 69 years at screening, and capable of long-term cooperation with screening and follow-up.

Description

Inclusion Criteria:

  • Residents with a definite native place;
  • Aged 30 and 69 years at screening;
  • Capable of long-term cooperation with screening and follow-up.

Exclusion Criteria:

  • Known severe cardiovascular, liver or kidney disease, or neuropsychiatric disorders;
  • History of previous malignant tumors;
  • Severe autoimmune diseases or immunodeficiency;
  • Females with a positive pregnancy test at screening;
  • Inability to cooperate with the study due to psychological, social, family, and geographical reasons.

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 of nasopharyngeal carcinoma
Population participating in nasopharyngeal carcinoma screening, aged between 30 and 69 years old.
Diagnostic test: EBV antibodies test
ELISA test of VCA-IgA, EBNA1-IgA, EA-IgA, Zta-IgA, Rta-IgG and P85-Ab in nasopharyngeal brushing and plasma in plasma, saliva and nasopharyngeal brushing.
Diagnostic test: EBV DNA test
quantitative polymerase chain reaction, methylation sequencing and target sequencing of EBV DNA in nasopharyngeal brushing, saliva and plasma.
Other: epidemiological information survey
epidemiological information survey including basic conditions, dietary and lifestyle habits, social, geographical, environmental, and other information.
Other: Clinical examinations for high-risk participants
nasopharyngoscopy, head and neck MRI.
Other: EBV and human genetic sequencing
EB virus and human genetic sequencing for plasma, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A data platform for an NPC screening cohort
Time Frame: At screening, 3 years and 10 years thereafter
A data platform, including an NPC epidemiological information database based on the gender, age, ethnicity, dietary and lifestyle habits, and geographical environmental factors, a biobank based on various samples and screening test results, and a clinical examination database based on nasopharyngoscopy, head and neck MRI, and a database for EB virus and human genetic sequencing information.
At screening, 3 years and 10 years thereafter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence and incidence rate of nasopharyngeal carcinoma
Time Frame: At screening, 3 years and 10 years thereafter
Endoscopy combined with or without biopsy is performed to evaluate the prevalence and rate of new cases of nasopharyngeal carcinoma, in a cohort study, and to identify the associated factors related with nasopharyngeal carcinoma.
At screening, 3 years and 10 years thereafter
Nasopharyngeal Carcinoma Death Rates
Time Frame: At screening, 3 years and 10 years thereafter
Nasopharyngeal Carcinoma deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.
At screening, 3 years and 10 years thereafter
Death Rates From All Causes
Time Frame: At screening, 3 years and 10 years thereafter
Deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.
At screening, 3 years and 10 years thereafter

Collaborators and Investigators

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

Sponsor

Ming-Yuan Chen

Collaborators

Sun Yat-sen University
Fifth Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Chair: Ming-yuan Chen, MD, PhD, Sun Yat-sen University

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)

November 14, 2024

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2045

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZDWY.BYAFZZX.030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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