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A cohort study of antibody-nucleic acid two-step method compared with plasma EBVDNA for nasopharyngeal carcinoma (NPC) screening in high-risk areas of China

A cohort study of antibody-nucleic acid two-step method compared with plasma EBVDNA for nasopharyngeal carcinoma (NPC) screening in high-risk areas of China

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600117497
Enrollment
Unknown
Registered
2026-01-26
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

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:Pathological examination
Index test:Two-step antibody and nucleic acid screening (serum EBNA-IgA and P85 antibody screening, plasma EBV DNA quantitative screening combined with sequencing if any positive)

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.Enrollment in the “Xijiang Project” screening cohort. 2.Age between 30 and 69 years at the time of screening.

Exclusion criteria

Exclusion criteria: 1.Known severe medical comorbidities, dysfunction of major organs (heart, lung, liver, or kidney), or neuropsychiatric disorders. 2.A history of malignant tumors. 3.Severe autoimmune diseases or an immunosuppressed state. 4.Women of childbearing age who test positive on a pregnancy test at the time of initial screening.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Secondary

MeasureTime frame
Positive Predictive Value(PPV);Negative Predictive Value( NPV);

Countries

China

Contacts

Public ContactChen Mingyuan

Fifth Affiliated Hospital, Sun Yat-Sen University

chenmy@sysucc.org.cn+86 20 87342422

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026