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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-75
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

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.

Eligibility criteria

Qualifiers

40-74 years old

Clinically and/or pathologically diagnosed cancer

No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc.

Able to provide a written informed consent and willing to comply with all part of the protocol procedures

Disqualifiers

Pregnancy or lactating women

Known prior or current diagnosis of other types of malignancies comorbidities

Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen

Recipients of organ transplant or prior bone marrow transplant or stem cell transplant

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

700 Participants
are grouped into 2 trial groups

Sponsors and collaborators

First Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Collaborator

Hainan People's Hospital

Collaborator

Xiangya Hospital of Central South University

Collaborator

First People's Hospital of Foshan

Collaborator

Zhongshan People's Hospital, Guangdong, China

Collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

Collaborator