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"Xijiang Project" Screening Cohort for NPC

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06787456
Enrollment
1000000
Registered
2025-01-22
Start date
2024-11-14
Completion date
2045-12-01
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma (NPC), Screening

Keywords

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

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.

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.

Interventions

DIAGNOSTIC_TESTEBV 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.

DIAGNOSTIC_TESTEBV DNA test

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

OTHERepidemiological information survey

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

OTHERClinical examinations for high-risk participants

nasopharyngoscopy, head and neck MRI.

OTHEREBV and human genetic sequencing

EB virus and human genetic sequencing for plasma, etc.

Sponsors

Ming-Yuan Chen
Lead SponsorOTHER
Fifth Affiliated Hospital, Sun Yat-Sen University
CollaboratorOTHER
Sun Yat-Sen University Cancer Center
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 69 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
A data platform for an NPC screening cohortAt screening, 3 years and 10 years thereafterA 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.

Secondary

MeasureTime frameDescription
Prevalence and incidence rate of nasopharyngeal carcinomaAt screening, 3 years and 10 years thereafterEndoscopy 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.
Nasopharyngeal Carcinoma Death RatesAt screening, 3 years and 10 years thereafterNasopharyngeal 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.
Death Rates From All CausesAt screening, 3 years and 10 years thereafterDeaths 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.

Countries

China

Contacts

CONTACTMing-yuan Chen, MD, PhD
chmingy@mail.sysu.edu.cn86-13903052650
CONTACTJiong-lin Liang, MD
liangjl@sysucc.org.cn86-13172018626
STUDY_CHAIRMing-yuan Chen, MD, PhD

Sun Yat-sen University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026