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NCT Number: NCT05884983

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

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.

Recruiting

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Key information

Age range

30 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

Location status: Recruiting

Location contact

fang Ming Ji, MD

CONTACT

[email protected]

86-0760-89880417

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

participants will undergo dual-energy CT and endoscopy

Procedure

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Zhongshan People's Hospital, Guangdong, China

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2023
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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