Nasopharyngeal Carcinoma (NPC)NCT06787456
"Xijiang Project" Screening Cohort for NPC
An observational study of Nasopharyngeal Carcinoma (NPC) and Screening, run by Ming-Yuan Chen at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC), Screening
- What is being tested?
- EBV antibodies test, EBV DNA test and epidemiological information survey
- How many people
- 1,000,000 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2024to Dec 2045
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Residents with a definite native place;
- Aged 30 and 69 years at screening;
- Capable of long-term cooperation with screening and follow-up.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Ming-Yuan Chen, MD, PhD, +86-13903052650, chmingy@mail.sysu.edu.cn
About this study
Official title: Establishment of "Xijiang Project" Million-Person Screening Cohort for Nasopharyngeal Carcinoma
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.
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma (NPC), Screening
- Being tested
- EBV antibodies test, EBV DNA test, epidemiological information survey, Clinical examinations for high-risk participants, EBV and human genetic sequencing
- Keywords
- Nasopharyngeal Carcinoma (NPC), screening, Epstein-Barr virus, EBV DNA, EBV antibody
- Medical subject headings
- Nasopharyngeal Carcinoma, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBV antibodies testDiagnostic 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.
EBV DNA testDiagnostic test
quantitative polymerase chain reaction, methylation sequencing and target sequencing of EBV DNA in nasopharyngeal brushing, saliva and plasma.
epidemiological information surveyOther
epidemiological information survey including basic conditions, dietary and lifestyle habits, social, geographical, environmental, and other information.
Clinical examinations for high-risk participantsOther
nasopharyngoscopy, head and neck MRI.
EBV and human genetic sequencingOther
EB virus and human genetic sequencing for plasma, etc.
| Study group | Role | What they receive |
|---|---|---|
| Screening cohort of nasopharyngeal carcinoma | Population participating in nasopharyngeal carcinoma screening, aged between 30 and 69 years old. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At screening, 3 years and 10 years thereafter
Secondary outcomes (3)
Prevalence and incidence rate of nasopharyngeal carcinoma
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.
Measured: At screening, 3 years and 10 years thereafter
Nasopharyngeal Carcinoma Death Rates
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.
Measured: At screening, 3 years and 10 years thereafter
Death Rates From All Causes
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.
Measured: At screening, 3 years and 10 years thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start14 Nov 2024
- Primary completionDec 2035 (estimated)
- Study completionDec 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ming-Yuan Chen
- Sponsor type
- University, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen University Cancer Center
- Responsible party
- Sponsor-investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Ming-yuan Chen, MD, PhD, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787456
- Sponsor's protocol ID
- ZDWY.BYAFZZX.030
- Status last verified
- Aug 2026
- First submitted
- 2 Jan 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of "Xijiang Project" Million-Person Screening Cohort for Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT06787456
- Acronym / sponsor ID
- ZDWY.BYAFZZX.030
- Conditions
- Nasopharyngeal Carcinoma (NPC), Screening
- Keywords
- Nasopharyngeal Carcinoma (NPC), screening, Epstein-Barr virus, EBV DNA, EBV antibody
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Ming-Yuan ChenUniversity, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen University Cancer Center
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2045 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening cohort of nasopharyngeal carcinoma | – | 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 sequencingPopulation participating in nasopharyngeal carcinoma screening, aged between 30 and 69 years old. |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Residents with a definite native place;
- Aged 30 and 69 years at screening;
- Capable of long-term cooperation with screening and follow-up.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBV antibodies testTest 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 test | Screening cohort of nasopharyngeal carcinoma |
| EBV DNA testquantitative polymerase chain reaction, methylation sequencing and target sequencing of EBV DNA in nasopharyngeal brushing, saliva and plasma. | Diagnostic test | Screening cohort of nasopharyngeal carcinoma |
| epidemiological information surveyepidemiological information survey including basic conditions, dietary and lifestyle habits, social, geographical, environmental, and other information. | Other | Screening cohort of nasopharyngeal carcinoma |
| Clinical examinations for high-risk participantsnasopharyngoscopy, head and neck MRI. | Other | Screening cohort of nasopharyngeal carcinoma |
| EBV and human genetic sequencingEB virus and human genetic sequencing for plasma, etc. | Other | Screening cohort of nasopharyngeal carcinoma |
Primary outcome
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.
3 secondary outcomes
Prevalence and incidence rate of nasopharyngeal carcinoma
Time frame: At screening, 3 years and 10 years thereafter
Nasopharyngeal Carcinoma Death Rates
Time frame: At screening, 3 years and 10 years thereafter
Death Rates From All Causes
Time frame: At screening, 3 years and 10 years thereafter
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming-yuan Chen, MD, PhD study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma (NPC) and Screening, run by Ming-Yuan Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming-yuan Chen, MD, PhD (86-13903052650, chmingy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A data platform for an NPC screening cohort (time frame: At screening, 3 years and 10 years thereafter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.