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Prospective Nasopharyngeal Carcinoma Screening Using Plasma Epstein-Barr Virus DNA Analysis

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Prospective 20,000-person Nasopharyngeal Carcinoma (NPC) Screening Programme Using Plasma Epstein-Barr Virus (EBV) DNA Analysis

Clinical Trial 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 detecting NPC cases at earlier stages and improve survival.

Clinical Trial 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. A second round of screening will be carried out at 3 to 5 years after the initial round of screening. Subjects will be screened with plasma EBV DNA as in the first round of screening. Subjects with initial positive results will be retested and those with persistently positive results will be investigated using nasal endoscopic examination and MRI of the nasopharynx. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02063399
Study type Observational
Source Chinese University of Hong Kong
Contact
Status Active, not recruiting
Phase
Start date July 2013
Completion date June 2023
View Details
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