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NCT02501993 Clinical Trial

Nasopharyngeal Carcinoma Screening in Zhongshan City

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Serology Screening Test for the Detection of Nasopharyngeal Carcinoma in Zhongshan City

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02501993
Other study ID # NPC-PRO-002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 2012
Est. completion date December 2023

Study information
Verified date July 2023
Source Zhongshan People's Hospital, Guangdong, China
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective is to determine the early diagnosis rate and mortality rate of the Nasopharyngeal Carcinoma (NPC) in the study population. The secondary objective is to determine the incidence of NPC in the study population.

Description:

The research is to evaluate the effect of NPC screening, also as an extended study of Screening for Nasopharyngeal Carcinoma in High Risk Populations (NCT00941538). The program was conducted in Xiaolan and Minzhong towns of Zhongshan city in 2012. All participants will be tested for anti-EBV antibody by using serum samples. Participants are stratified into those having high, moderate and low antibody levels, those having moderate antibody levels are invited to retest annually in the following 3 years and those found to have high antibody levels on these occasions are referred to centers for diagnostic workup for NPC.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 25000
Est. completion date December 2023
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 59 Years
Eligibility Inclusion Criteria: - Subject residents in Zhongshan city - Subject is 30 to 59 years of age inclusive - Subject has no medical record of nasopharyngeal carcinoma - ECOG 0-2 - Subject has psychical condition and well consciousness - Subject is able to comprehend, sign, and date the written informed consent document to participate in the study. Exclusion Criteria: - Subject has heavy cardiovascular, liver or kidney disease - Subject has medical record of nasopharyngeal carcinoma - Subject who is not residing in Zhongshan City

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Zhongshan People's Hospital Zhongshan Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The early detection rate (stage I and II) of Nasopharyngeal Carcinoma 10 years
Primary The mortality rate of Nasopharyngeal Carcinoma 10 years
Secondary The incidence of Nasopharyngeal Carcinoma 10 years
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