Brief Title
Prospective Nasopharyngeal Carcinoma Screening Using Plasma Epstein-Barr Virus DNA Analysis
Official Title
Prospective 20,000-person Nasopharyngeal Carcinoma (NPC) Screening Programme Using Plasma Epstein-Barr Virus (EBV) DNA Analysis
Brief Summary
The purpose of this study is to determine if the screening of nasopharyngeal carcinoma using plasma Epstein-Barr virus DNA analysis would result in the down-staging of the NPC cases in asymptomatic individuals.
Detailed Description
Epstein-Barr virus (EBV) infection is an important etiological factor for nasopharyngeal carcinoma (NPC). In a pilot study, we have shown that the analysis of Epstein-Barr virus (EBV) DNA in blood can detect early and asymptomatic NPC. However, it is unlcear if NPC screening can improve the prognosis of the screened NPC subjects. 20,000 male subjects aged from 40 to 62 will be recruited because the incidence of NPC is higher in this target group. Twenty millilitres of venous blood will be collected from each subject at enrolment for plasma EBV DNA analysis. Subjects who have initial positive results for plasma EBV DNA will have another testing at approximately 4 weeks. Subjects who have persistently positive results for the two plasma EBV DNA analyses will be investigated using nasal endoscopic examination and MRI of the nasopharynx. After the initial screening, all participants will be phone interviewed yearly to update their cancer status.
Study Type
Observational
Primary Outcome
Stage distribution of nasopharyngeal carcinoma at the time of diagnosis
Secondary Outcome
Incidence of nasopharyngeal carcinoma in screened negative group
Condition
Nasopharyngeal Carcinoma
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
20302
Start Date
July 2013
Completion Date
June 2023
Primary Completion Date
August 2016
Eligibility Criteria
Inclusion Criteria: - age 40 to 62 years - ethnic Chinese - male Exclusion Criteria: - history of nasopharyngeal carcinoma - currently having a malignant disease - active autoimmune disease - HIV infection - on systemic steroid treatment - on immunosuppressant treatment
Gender
Male
Ages
40 Years - 62 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Kwan-chee Allen Chan, MD, PhD, ,
Location Countries
Hong Kong
Location Countries
Hong Kong
Administrative Informations
NCT ID
NCT02063399
Organization ID
CU-ChemPath-001
Responsible Party
Principal Investigator
Study Sponsor
Chinese University of Hong Kong
Study Sponsor
Kwan-chee Allen Chan, MD, PhD, Principal Investigator, Chinese University of Hong Kong
Verification Date
February 2020