"Xijiang Project" Screening Cohort for NPC

NCT06787456 | Active Not Recruiting DMC

• 1 other identifier: ZDWY.BYAFZZX.030
• Study Type: observational
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nasopharyngeal Carcinoma (NPC); Screening

Keywords

Nasopharyngeal Carcinoma (NPC); screening; Epstein-Barr virus; EBV DNA; EBV antibody

Outcome Measures

Primary Outcomes (1)

• A data platform for an NPC screening cohort

  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 Outcomes (3)

• Prevalence and incidence rate of nasopharyngeal carcinoma

  At screening, 3 years and 10 years thereafter

• Nasopharyngeal Carcinoma Death Rates

  At screening, 3 years and 10 years thereafter

• Death Rates From All Causes

  At screening, 3 years and 10 years thereafter

Study Arms (1)

Screening cohort of nasopharyngeal carcinoma

Population participating in nasopharyngeal carcinoma screening, aged between 30 and 69 years old.

Diagnostic Test: EBV antibodies test; Diagnostic Test: EBV DNA test; Other: epidemiological information survey; Other: Clinical examinations for high-risk participants; Other: EBV and human genetic sequencing

Interventions

EBV antibodies test DIAGNOSTIC_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.

Screening cohort of nasopharyngeal carcinoma

EBV DNA test DIAGNOSTIC_TEST

quantitative polymerase chain reaction, methylation sequencing and target sequencing of EBV DNA in nasopharyngeal brushing, saliva and plasma.

Screening cohort of nasopharyngeal carcinoma

epidemiological information survey OTHER

epidemiological information survey including basic conditions, dietary and lifestyle habits, social, geographical, environmental, and other information.

Screening cohort of nasopharyngeal carcinoma

Clinical examinations for high-risk participants OTHER

nasopharyngoscopy, head and neck MRI.

Screening cohort of nasopharyngeal carcinoma

EBV and human genetic sequencing OTHER

EB virus and human genetic sequencing for plasma, etc.

Screening cohort of nasopharyngeal carcinoma

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ming-Yuan Chen: lead
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• Sun Yat-sen University: collaborator

Study Sites (1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

nasopharyngeal brushing, saliva, peripheral blood, etc.

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Epstein-Barr Virus Infections

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Ming-yuan Chen, MD, PhD

  Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professior, Chief physician

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 22, 2025
• Study Start: November 14, 2024
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2045
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CN (1)