Clinical trial NCT06787456: "Xijiang Project" Screening Cohort for NPC
Official title: Establishment of "Xijiang Project" Million-Person Screening Cohort for Nasopharyngeal Carcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Nasopharyngeal Carcinoma (NPC)
Screening
Keywords: Nasopharyngeal Carcinoma (NPC)
screening
Epstein-Barr virus
EBV DNA
EBV antibody
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: Sun Yat-sen University
First posted: 2025-01-22
Enrollment: 1000000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: A data platform for an NPC screening cohort
timeFrame: At screening, 3 years and 10 years thereafter
Secondary outcomes:
measure: Prevalence and incidence rate of nasopharyngeal carcinoma
timeFrame: At screening, 3 years and 10 years thereafter
measure: Nasopharyngeal Carcinoma Death Rates
timeFrame: At screening, 3 years and 10 years thereafter
measure: Death Rates From All Causes
timeFrame: At screening, 3 years and 10 years thereafter
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming-yuan Chen, MD, PhD
role: STUDY_CHAIR
References: