Screening Effect of Dual-energy CT Combined With Nasopharyngeal Endoscopy for Screening Nasopharyngeal Carcinoma

August 11, 2025 updated by: Mingfang Ji, Zhongshan People's Hospital, Guangdong, China
All participants will be tested for EBV-related biomarkers, including EBNA1-IgA, VCA-IgA, and BNLF2b total antibody (P85-Ab), and participants with high serologic risk will be selected based on serologic test results, and dual-energy CT will be performed first for high-risk screening subjects, and dual-energy CT will be performed first for the high-risk group to record dual-energy CT examinations of those suspected of nasopharyngeal carcinoma, and then endoscopy was performed on the high-risk group to record those suspected of nasopharyngeal carcinoma under endoscopy, and finally biopsies were taken for positive lesion sites indicated by dual-energy CT and suspicious lesion sites found by endoscopy to clarify the diagnosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

12000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Zhongshan, Guangdong, China, 528403
        • Recruiting
        • Zhongshan People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

30-69 years old healthy residences in Zhongshan City

Description

Inclusion Criteria:

  • Subject residents in Zhongshan City
  • Subject has no medical record of nasopharyngeal carcinoma
  • Subject is able to comprehend, sign, and date the written informed consent document to participate in the study
  • Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study

Exclusion Criteria:

  • Subject has heavy cardiovascular, liver or kidney disease
  • Subject has contraindications to nasopharyngeal endoscopy
  • Subject has contrast media allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Screening cohort
30-69 years old healthy participants in Zhongshan
Procedure: participants will undergo dual-energy CT and endoscopy
Diagnostic Test: P85-Ab,EBNA1-IgA,and VCA-IgA. Detect P85-Ab, EBNA1-IgA, VCA-IgA for all participants and select serological high-risk participants DiagnosticTest: dual-energy CT, endoscopy and biopsy. serological high-risk participants will refer to dual-energy CT, endoscopy and biospy
Other Names:
  • Biological/Vaccine: Blood and saliva Collect blood and saliva samples from participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of dual-energy CT and endoscopy in the diagnosis of nasopharyngeal carcinoma
Time Frame: 6 months
To compare the sensitivity [actual number of nasopharyngeal cancers in the population considered by dual-energy CT or endoscopy / (actual number of nasopharyngeal cancers in the population considered by dual-energy CT or endoscopy + number of nasopharyngeal cancers in the non-nasopharyngeal cancer population considered by dual-energy CT or endoscopy)] and specificity [actual number of non-nasopharyngeal cancers in the population considered by dual-energy CT or endoscopy / ( actual number of non-nasopharyngeal cancers in the population considered by dual-energy CT or endoscopy + number of non-nasopharyngeal cancers in the nasopharyngeal cancer population considered by dual-energy CT or endoscopy)] of dual-energy CT and endoscopy in the diagnosis of nasopharyngeal carcinoma, and to determine which test is more accurate in detecting nasopharyngeal carcinoma from the population
6 months
Positive and negative predictive values of dual-energy CT and endoscopy in the diagnosis of nasopharyngeal carcinoma
Time Frame: 6 months
To compare the positive predictive value [actual number of nasopharyngeal cancers in the population considered by dual-energy CT or endoscopy / (actual number of nasopharyngeal cancers in the population considered by dual-energy CT or endoscopy + number of non-nasopharyngeal cancers in the nasopharyngeal cancer population considered by dual-energy CT or endoscopy )] and negative predictive value [actual number of non-nasopharyngeal cancers in the population considered by dual-energy CT or endoscopy / (actual number of non-nasopharyngeal cancers in the population considered by dual-energy CT or endoscopy + number of nasopharyngeal cancers in the non-nasopharyngeal cancer population considered by dual-energy CT or endoscopy)] of dual-energy CT and endoscopy in the diagnosis of nasopharyngeal carcinoma
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan People's Hospital, Guangdong, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-PRO-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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