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

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.

NCT Number	NCT06763289
Lead Sponsor	First Affiliated Hospital, Sun Yat-Sen University Collaborators: First Affiliated Hospital of Fujian Medical University, Hainan People's Hospital, Xiangya Hospital of Central South University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China, Sixth Affiliated Hospital, Sun Yat-sen University, Fifth Affiliated Hospital, Sun Yat-Sen University, People's Hospital of Guangxi Zhuang Autonomous Region
Conditions	Nasopharyngeal Carcinoma (NPC)
Enrollment	700 participants
Start Date	2024-12-25
Primary Completion	2025-12-31 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-01-08