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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Nasopharyngeal Carcinoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage distribution of nasopharyngeal carcinoma at the time of diagnosis | All the participants will be subjected to the screening of nasopharyngeal carcinoma (NPC) at the time of recruitment using plasma EBV DNA analysis. Subjects with positive results will be investigated using endoscopic examination and MRI. If the subject is confirmed of having NPC, the stage of the disease would be recorded. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of nasopharyngeal carcinoma in screened negative group | Participants who are screened negative will be followed up yearly for 5 years after the screening. The incidence of NPC will be recorded. | 5 years | 
| Relative risk of developing nasopharyngeal carcinoma for subjects with positive test results | The relative risk of developing nasopharyngeal carcinoma for subjects with negative, transiently positive and persistently positive plasma Epstein-Barr virus DNA at enrolment will be determined. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NPC, Cancer screening, Plasma EBV DNA