Skip to content

A Prospective Head-to-Head Comparison Trial of Plasma EBV DNA or P85 Antibody versus VCA-IgA/EBNA1-IgA and Strategy Optimization for Nasopharyngeal Carcinoma Screening in High-Incidence Regions

A Prospective Head-to-Head Comparison Trial of Plasma EBV DNA or P85 Antibody versus VCA-IgA/EBNA1-IgA and Strategy Optimization for Nasopharyngeal Carcinoma Screening in High-Incidence Regions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500103200
Enrollment
Unknown
Registered
2025-05-27
Start date
2025-05-31
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Gold Standard:Nasopharyngoscopy with or without biopsy for screening-positive participants and follow-up for 10 years.
Index test:Diagnostic Test: EBNA1-IgA, VCA-IgA, P85-Ab and EBV DNA. Two-step method and single-step method. Novel screening biomarkers including next-generation sequencing for EBV and castoff cells us

Sponsors

Fifth Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1.Voluntarily signed informed consent. 2.Age between 30 and 69 years at the time of screening. 3.Residents of Guangdong Province or Guangxi Province. 4.Able to cooperate with long-term follow-up.

Exclusion criteria

Exclusion criteria: 1.Severe medical comorbidities, significant organ (heart, lung, liver, kidney) dysfunction, or psychiatric disorders. 2.Severe autoimmune diseases or immunodeficiency. 3.History of or current malignant tumors. 4.Inability to cooperate with the study due to psychological, social, familial, or geographical reasons.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of EBV DNA testing, P85-Ab testing and the two-antibody method testing;Sensitivity and positive predictive value (PPV) of the two-step method, single-step method and each single screening testing.;

Secondary

MeasureTime frame
Nasopharyngeal Carcinoma Death Rates;Negative predictive value;Area under the ROC curve;Early diagnosis rate of nasopharyngeal carcinoma;Death Rates From All Causes;

Countries

China

Contacts

Public ContactYou rui

The Fifth Affiliated Hospital, Sun Yat-Sen University

yourui@sysucc.org.cn+86 135 8043 9820

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026