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Active, Not Recruiting

NCT Number: NCT06787456

"Xijiang Project" Screening Cohort for NPC

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

EBV DNA test

Diagnostic Test

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

epidemiological information survey

Other

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

Clinical examinations for high-risk participants

Other

nasopharyngoscopy, head and neck MRI.

EBV and human genetic sequencing

Other

EB virus and human genetic sequencing for plasma, etc.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ming-Yuan Chen

Other

Collaborators

  • Fifth Affiliated Hospital, Sun Yat-Sen University
  • Sun Yat-Sen University Cancer Center

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2035
Study completion
2045
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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