Brief Title
Nasopharyngeal Carcinoma Screening in Zhongshan City
Official Title
Serology Screening Test for the Detection of Nasopharyngeal Carcinoma in Zhongshan City
Brief 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.
Detailed 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.
Study Type
Observational
Primary Outcome
The early detection rate (stage I and II) of Nasopharyngeal Carcinoma
Secondary Outcome
The incidence of Nasopharyngeal Carcinoma
Condition
Nasopharyngeal Carcinoma
Study Arms / Comparison Groups
Screening cohort
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
25000
Start Date
March 2012
Completion Date
December 2022
Primary Completion Date
March 2022
Eligibility Criteria
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
Gender
All
Ages
30 Years - 59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Mingfang Ji, M.D./Ph.D., , [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02501993
Organization ID
NPC-PRO-002
Responsible Party
Principal Investigator
Study Sponsor
Zhongshan People's Hospital, Guangdong, China
Study Sponsor
Mingfang Ji, M.D./Ph.D., Principal Investigator, Zhongshan People's Hospital, Guangdong, China
Verification Date
July 2019