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RecruitingNCT05884983Updated Aug 15, 2025

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

An observational study in Nasopharyngeal Carcinoma, sponsored by Zhongshan People's Hospital, Guangdong, China. Recruiting at 1 site in China. Open to participants aged 30 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-15.

Sponsored by Zhongshan People's Hospital, Guangdong, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12,000
Ages
30 Years to 69 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Nasopharyngeal Carcinoma

Keywords

  • Screening
  • Nasopharyngeal Carcinoma
  • Dual-energy CT
  • Endoscopy
03

Who can participate

Ages eligible
30 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

30-69 years old healthy residences in Zhongshan City

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

Exclusion Criteria:

  • Subject has heavy cardiovascular, liver or kidney disease
  • Subject has contraindications to nasopharyngeal endoscopy
  • Subject has contrast media allergy
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12,000 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Screening cohort

    30-69 years old healthy participants in Zhongshan

    Procedure: participants will undergo dual-energy CT and endoscopy

Interventions

  • Procedureparticipants 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

    Also known as: Biological/Vaccine: Blood and saliva Collect blood and saliva samples from participants

05

What researchers measure

Primary outcomes

  1. Sensitivity and specificity of dual-energy CT and endoscopy in the diagnosis of nasopharyngeal carcinoma

    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

    Time frame: 6 months

  2. Positive and negative predictive values of dual-energy CT and endoscopy in the diagnosis of nasopharyngeal carcinoma

    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

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Zhongshan People's Hospital
    Zhongshan, Guangdong 528403, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05884983
Lead sponsor
Zhongshan People's Hospital, Guangdong, China
Responsible party
Mingfang Ji (Clinical Professor, Zhongshan People's Hospital, Guangdong, China) — Principal investigator
First posted
Jun 1, 2023
Start date
Feb 1, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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