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Trial Title:
Screening Effect of Dual-energy CT Combined With Nasopharyngeal Endoscopy for Screening Nasopharyngeal Carcinoma
NCT ID:
NCT05884983
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Vaccines
Conditions: Keywords:
Screening
Nasopharyngeal Carcinoma
Dual-energy CT
Endoscopy
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
participants will undergo dual-energy CT and endoscopy
Description:
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
Arm group label:
Screening cohort
Other name:
Biological/Vaccine: Blood and saliva Collect blood and saliva samples from participants
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.
Criteria for eligibility:
Study pop:
30-69 years old healthy residences in Zhongshan City
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
30 Years
Maximum age:
69 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Zhongshan People's Hospital
Address:
City:
Zhongshan
Zip:
528403
Country:
China
Status:
Recruiting
Contact:
Last name:
fang Ming Ji, MD
Phone:
86-0760-89880417
Email:
jmftbh@sina.com
Start date:
February 1, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Zhongshan People's Hospital, Guangdong, China
Agency class:
Other
Source:
Zhongshan People's Hospital, Guangdong, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05884983