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

NCT05884983 | Recruiting

• 1 other identifier: NPC-PRO-004
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Screening; Nasopharyngeal Carcinoma; Dual-energy CT; Endoscopy

Outcome Measures

Primary Outcomes (2)

• 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

  6 months

• 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

  6 months

Study Arms (1)

Screening cohort

30-69 years old healthy participants in Zhongshan

Procedure: participants will undergo dual-energy CT and endoscopy

Interventions

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

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

Screening cohort

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30-69 years old healthy residences in Zhongshan City

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zhongshan People's Hospital, Guangdong, China: lead

Study Sites (1)

Zhongshan People's Hospital

Zhongshan, Guangdong, 528403, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and saliva samples

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Endoscopy; Biological Products

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 1, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)