Comparison of Multi-omics Models for Early Nasopharyngeal Carcinoma Screening: CfDNA Methylation, EBV DNA, and Serological Double-antibodies Detection

Recruiting

• Conditions: Nasopharyngeal Carcinoma (NPC)

• Registration Number: NCT06763289
• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Brief Summary

This study focus on nasopharyngeal carcinoma, a cancer type with Chinese characteristics, analyze the early screening detection performance of nasopharyngeal carcinoma in the multi-cancer early screening model, and compare the performance differences among multi-omics models such as nasopharyngeal carcinoma-specific DNA methylation and fragmentome in the multi-cancer early screening model and the clinically routinely conducted Epstein-Barr virus (EBV) nucleic acid quantification (EBV DNA) test and serological double antibody (double antibodies of EBNA1-IgA and VCA-IgA) test. It suggests that compared with EBV DNA quantification and double antibody tests, in patients with nasopharyngeal carcinoma, multi-omics models such as DNA methylation can avoid false negatives, improve sensitivity, and increase the detection rate of early-stage nasopharyngeal carcinoma; in patients without nasopharyngeal carcinoma, multi-omics models such as DNA methylation can avoid false positives, improve specificity, and avoid unnecessary over-diagnosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-21
• Study Start: 2024-12-25
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
False positive rate and false negative rate of ctDNA Methylation model, EBV DNA quantification test, double antibodies of EBNA1-IgA and VCA-IgA test	2 year	To analyze the early screening detection performance of nasopharyngeal carcinoma in the multi-cancer early screening model, and compare the false positive rate and false negative rate among in the multi-cancer early screening model and the clinically routinely conducted Epstein-Barr virus (EBV) nucleic acid quantification (EBV DNA) test and serological double antibody (double antibodies of EBNA1-IgA and VCA-IgA) test.
Sensitivity and specificity of ctDNA Methylation model, EBV DNA quantification test, double antibodies of EBNA1-IgA and VCA-IgA test in the Screening of nasopharyngeal carcinoma	2 year	To analyze the early screening detection performance of nasopharyngeal carcinoma in the multi-cancer early screening model, and compare the sensitivity and specificity among in the multi-cancer early screening model and the clinically routinely conducted Epstein-Barr virus (EBV) nucleic acid quantification (EBV DNA) test and serological double antibody (double antibodies of EBNA1-IgA and VCA-IgA) test.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity of ctDNA Methylation model, EBV DNA quantification test, double antibodies of EBNA1-IgA and VCA-IgA test in the detection of early-stage nasopharyngeal carcinoma	2 year	To analyze the early screening detection performance of nasopharyngeal carcinoma in the multi-cancer early screening model, and compare the sensitivity and specificity among in the multi-cancer early screening model and the clinically routinely conducted Epstein-Barr virus (EBV) nucleic acid quantification (EBV DNA) test and serological double antibody (double antibodies of EBNA1-IgA and VCA-IgA) test in the detection of stage I/II nasopharyngeal carcinoma.
Modeled positive and negative predictive values of ctDNA Methylation model, EBV DNA quantification test, double antibodies of EBNA1-IgA and VCA-IgA test	2 year	The difference in positive and negative predictive values was calculated combined with the incidence of nasopharyngeal carcinoma and compared among in the multi-cancer early screening model and the clinically routinely conducted Epstein-Barr virus (EBV) nucleic acid quantification (EBV DNA) test and serological double antibody (double antibodies of EBNA1-IgA and VCA-IgA) test.

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China