Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City

NCT04085900 | Recruiting

• 1 other identifier: NPC-PRO-003
• Study Type: observational
• Target: 40,000
• Locations: 1 country
• Sites: 2

Brief Summary

The study includes two cohorts: (1) a serological screening cohort; (2) a serological and EBV DNA screening cohort. All participants will be tested for EBNA1-IgA, VCA-IgA, BNLF2b total antibodies (P85-Ab), with additional plasma EBV DNA testing in the latter cohort. Screening positive participants will be followed up annually. All subjects will also be followed by record linkage to Cancer Register and Population Register.

Conditions

Nasopharyngeal Carcinoma

Keywords

Screening; Nasopharyngeal Carcinoma; Biomarker

Outcome Measures

Primary Outcomes (2)

• Sensitivity and specificity of different EBV associated biomarkers

  To compare the sensitivity and specificity of different EBV associated biomarkers for NPC

  5 years

• Positive and negative predictive values of different EBV associated biomarkers

  To compare the positive and negative predictive values of different EBV associated biomarkers for NPC

  5 years

Secondary Outcomes (2)

• Number needed to screen to identify one nasopharyngeal carcinoma

  5 years

• Early diagnosis rate of nasopharyngeal carcinoma

  5 years

Other Outcomes (2)

• The health economic benefits of different biomarkers for nasopharyngeal carcinoma

  5 years

• New screening strategy of nasopharyngeal carcinoma screening

  5 years

Study Arms (2)

Serological screening cohort

30-69 years old healthy participants.

Biological: Blood and saliva; Diagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA; Diagnostic Test: Fiberoptic endoscopy and biopsy

Serological and EBV DNA screening cohort

30-69 years old healthy participants.

Biological: Blood and saliva; Diagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA; Diagnostic Test: Consecutive EBV DNA testing; Diagnostic Test: Fiberoptic endoscopy and biopsy

Interventions

Blood and saliva BIOLOGICAL

Collect blood and saliva samples from participants

Serological and EBV DNA screening cohort; Serological screening cohort

Fiberoptic endoscopy and biopsy DIAGNOSTIC_TEST

Screening participants with high risk or P85-Ab positive will refer to fiberoptic endoscopy and biospy

Serological screening cohort

P85-Ab, EBNA1-IgA, VCA-IgA DIAGNOSTIC_TEST

Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants.

Serological and EBV DNA screening cohort; Serological screening cohort

Consecutive EBV DNA testing DIAGNOSTIC_TEST

All participants undergo baseline EBV DNA testing. Those with positive results are invited for repeat testing approximately 4 weeks later. Consecutive positivity is defined as positive results at both tests.

Serological and EBV DNA screening cohort

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30-69 years old healthy residences in Zhongshan City and Wuzhou City.

You may qualify if:

• Subject residents in Zhongshan City or Wuzhou City
• Subject has no medical record of nasopharyngeal carcinoma
• ECOG 0-2
• Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
• Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.

You may not qualify if:

• Subject has heavy cardiovascular, liver or kidney disease.
• Subject has contraindications to nasopharyngeal fiberoptic endoscopy.

Sponsors & Collaborators

• Zhongshan People's Hospital, Guangdong, China: lead
• Wuzhou Red Cross Hospital: collaborator
• Xiamen University: collaborator

Study Sites (2)

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, 543002, China

RECRUITING

Related Publications (1)

• Li T, Li F, Guo X, Hong C, Yu X, Wu B, Lian S, Song L, Tang J, Wen S, Gao K, Hao M, Cheng W, Su Y, Zhang S, Huang S, Fang M, Wang Y, Ng MH, Chen H, Luo W, Ge S, Zhang J, Xia N, Ji M. Anti-Epstein-Barr Virus BNLF2b for Mass Screening for Nasopharyngeal Cancer. N Engl J Med. 2023 Aug 31;389(9):808-819. doi: 10.1056/NEJMoa2301496.

  PMID: 37646678 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and saliva samples

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Blood Specimen Collection; Biopsy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• Mingfang Ji, MD

  Zhongshan People's Hospital, Guangdong, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingfang Ji, MD

CONTACT

86-760-89880417; jmftbh@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mingfang Ji

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: April 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 29, 2026

Record last verified: 2026-04

Locations

CN (2)