Optimizing screening methods for nasopharyngeal carcinoma using EBV biomarkers
Comparison and Strategy Optimization of Plasma Epstein-Barr Virus (EBV) DNA and BNLF2b Total Antibodies (P85-Ab) with VCA-IgA and EBNA1-IgA for Screening Nasopharyngeal Carcinoma in High-risk Areas
This study is testing new ways to screen for nasopharyngeal cancer using blood tests for certain virus markers to see if they work better than the current methods for people at high risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68649 (estimated) |
| Ages | 30 Years to 69 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Zhuhai, Guangdong) |
| Trial ID | NCT06870435 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, self-controlled, multicenter investigation aimed at improving the screening strategies for nasopharyngeal carcinoma (NPC) in high-risk areas. Participants will be tested for various Epstein-Barr virus (EBV) associated biomarkers, including plasma EBV DNA and P85-Ab, alongside the standard two-antibody method. The study seeks to determine if these new testing methods can provide higher sensitivity while maintaining specificity compared to current practices. Additionally, novel biomarkers will be explored through next-generation sequencing and nasopharyngeal swabs to enhance screening accuracy.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 30 to 69 years residing in Guangdong or Guangxi Province who are at high risk for nasopharyngeal carcinoma.
Not a fit: Patients with severe medical comorbidities, current malignant tumors, or significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and accurate screening methods for nasopharyngeal carcinoma, potentially improving early detection and patient outcomes.
How similar studies have performed: Other studies have shown promise in using EBV biomarkers for NPC screening, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Voluntarily signed informed consent. * Age between 30 and 69 years at the time of screening. * Residents of Guangdong Province or Guangxi Province. * Able to cooperate with long-term follow-up. Exclusion Criteria: * Severe medical comorbidities, significant organ (heart, lung, liver, kidney) dysfunction, or psychiatric disorders. * Severe autoimmune diseases or immunodeficiency. * History of or current malignant tumors. * Inability to cooperate with the study due to psychological, social, familial, or geographical reasons.
Where this trial is running
Zhuhai, Guangdong
- The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Ming-yuan Chen, MD, PhD
- Email: chmingy@mail.sysu.edu.cn
- Phone: 86-13903052650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.