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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-69
SponsorZhongshan People's Hospital, Guangdong, China

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Subject has heavy cardiovascular, liver or kidney disease

Subject has contraindications to nasopharyngeal endoscopy

Subject has contrast media allergy

Trial population

30-69 years old healthy residences in Zhongshan City

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • participants will undergo dual-energy CT and endoscopy

    Procedure/Surgery

    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

Treatment groups

12,000 Participants
are divided into 1 treatment group
Group A: Screening cohort1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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