Clinical trial · Observational
Screening Nasopharyngeal Carcinoma With EBV Associated Biomarkers in Zhongshan City
Searching for Early Detection Biomarkers of Nasopharyngeal Carcinoma in Zhongshan City
NCT04085900CI-TRIAL-00067975recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood and saliva | Biological | — | UNRESOLVED |
| Consecutive EBV DNA testing | Diagnostic Test | — | UNRESOLVED |
| Fiberoptic endoscopy and biopsy | Diagnostic Test | — | UNRESOLVED |
| P85-Ab, EBNA1-IgA, VCA-IgA | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Serological screening cohort
- description
- 30-69 years old healthy participants.
- interventionNames
- Biological: Blood and saliva
- Diagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA
- Diagnostic Test: Fiberoptic endoscopy and biopsy
- label
- Serological and EBV DNA screening cohort
- description
- 30-69 years old healthy participants.
- interventionNames
- Biological: Blood and saliva
- Diagnostic Test: P85-Ab, EBNA1-IgA, VCA-IgA
- Diagnostic Test: Consecutive EBV DNA testing
- Diagnostic Test: Fiberoptic endoscopy and biopsy
Primary outcomes (2)
- measure
- Sensitivity and specificity of different EBV associated biomarkers
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Subject has heavy cardiovascular, liver or kidney disease. * Subject has contraindications to nasopharyngeal fiberoptic endoscopy.
References
Publications (1)
- DERIVEDLi 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