"Xijiang Project" Screening Cohort for NPC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-14

Study Completion Date

2045-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasopharyngeal Carcinoma (NPC) Screening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Screening cohort of nasopharyngeal carcinoma

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

EBV antibodies test

Intervention Type 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.

EBV DNA test

Intervention Type DIAGNOSTIC_TEST

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

epidemiological information survey

Intervention Type OTHER

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

Clinical examinations for high-risk participants

Intervention Type OTHER

nasopharyngoscopy, head and neck MRI.

EBV and human genetic sequencing

Intervention Type OTHER

EB virus and human genetic sequencing for plasma, etc.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

EBV DNA test

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

Intervention Type DIAGNOSTIC_TEST

epidemiological information survey

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

Intervention Type OTHER

Clinical examinations for high-risk participants

nasopharyngoscopy, head and neck MRI.

Intervention Type OTHER

EBV and human genetic sequencing

EB virus and human genetic sequencing for plasma, etc.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes