"Xijiang Project" Screening Cohort for NPC

August 28, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • The fifth affiliated hospital of sun yat-sen university
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Screening cohort of nasopharyngeal carcinoma
Population participating in nasopharyngeal carcinoma screening, aged between 30 and 69 years old.
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.
Diagnostic test: EBV antibodies test
Test for VCA-IgA, EBNA1-IgA, EA-IgA, Zta-IgA, Rta-IgG and P85-Ab in nasopharyngeal brushing and plasma in plasma, saliva and nasopharyngeal brushing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ming-Yuan Chen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fifth Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen University Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2035

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2045

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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