Actively Recruiting

Age: 40Years - 75Years
All Genders
Healthy Volunteers
ID06763289

Comparison Between Multi-omics Models Including DNA Methylation in CfDNA, Quantitative Determination of Epstein-Barr Virus Nucleic Acid and Serological Double Antibody Detection in Early Screening of Nasopharyngeal Carcinoma

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

700

Participants Needed

1

Research Sites

78 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

Researchers are evaluating early screening methods for nasopharyngeal carcinoma (NPC), a cancer with distinct characteristics in Chinese populations. This study compares the performance of multi-omics models, including DNA methylation and fragmentome analysis, with routine clinical tests such as Epstein-Barr virus (EBV) DNA quantification and serological double antibody tests. The goal is to improve detection accuracy, reduce false positives and negatives, and increase early-stage NPC diagnosis rates. The study includes two groups: participants newly diagnosed with NPC and participants without a cancer diagnosis after routine screening. It assesses multi-omics models like circulating cell-free DNA (cfDNA) methylation alongside EBV DNA and antibody tests over a two-year period. These tests are evaluated for sensitivity, specificity, and predictive values in detecting NPC and early-stage disease. Participants aged 40 to 74 will provide consent and undergo screening tests without receiving treatment interventions. Researchers will monitor false positive and negative rates, sensitivity, specificity, and predictive values of the tests. The study involves observing outcomes for two years to assess early detection accuracy while participants continue their usual care. The trial is sponsored by the First Affiliated Hospital, Sun Yat-Sen University.

CONDITIONS

Brief 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...

  • For Case Arm: Aged 40 to 74 years
  • Clinically and/or pathologically diagnosed with nasopharyngeal carcinoma
  • No prior or ongoing systemic or local antitumor treatments like surgery, radiochemotherapy, or immunotherapy
  • Able to provide written informed consent and agree to follow all study procedures
  • For Control Arm: Aged 40 to 74 years
  • No confirmed cancer diagnosis
  • Able to provide written informed consent and agree to follow all study procedures
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Known current or prior diagnosis of other types of cancer
  • Severe acute infection or fever (body temperature ≥ 38.5 °C) within 14 days before screening
  • History of organ, bone marrow, or stem cell transplant
  • Blood transfusion within 30 days before screening
  • Received therapy such as antibiotics, glucocorticoids, or specific drugs in the past 14 days
  • Determined unsuitable for the trial by the researchers

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 2 years

Participants undergo tests including DNA methylation in cfDNA, Epstein-Barr virus nucleic acid quantification, and serological double antibody detection to evaluate for nasopharyngeal carcinoma.

1 to 2 visits depending on cohort assignment

Long-term Monitoring

Duration - Up to 2 years

Participants are observed over time to monitor test results and outcomes related to nasopharyngeal carcinoma screening.

Periodic visits over 2 years

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510000

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Research Team

W

WeiPing Wen

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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