Actively Recruiting

Age: 40Years - 75Years
All Genders
Healthy Volunteers
NCT06763289

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

Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2025-01-08

700

Participants Needed

1

Research Sites

131 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital, Sun Yat-Sen University

Lead Sponsor

F

First Affiliated Hospital of Fujian Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 40 to 74 years old
  • Clinically and/or pathologically diagnosed cancer (case arm only)
  • No prior or ongoing systemic or local antitumor therapy
  • Able to provide written informed consent and comply with study procedures
  • Without confirmed cancer diagnosis (control arm only)
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Prior or current diagnosis of other malignancies
  • Severe acute infection or fever (≥ 38.5 °C) within 14 days prior to screening
  • Organ transplant or prior bone marrow/stem cell transplant recipients
  • Blood transfusion within 30 days prior to screening
  • Therapy with antibiotics, glucocorticoids, or certain drugs within 14 days prior to screening
  • Unsuitable for the trial as determined by researchers

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

W

WeiPing Wen

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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