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

Active, not recruiting

• Conditions: Nasopharyngeal Carcinoma

• Registration Number: NCT02063399
• Lead Sponsor: Chinese University of Hong Kong

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 detecting NPC cases at earlier stages and improve survival.

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.

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 Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-13
• Study First Posted: 2014-02-14
• Primary Completion: 2016-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-17
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 20302

Inclusion Criteria

• age 40 to 62 years
• ethnic Chinese
• male

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Exclusion Criteria

• history of nasopharyngeal carcinoma
• currently having a malignant disease
• active autoimmune disease
• HIV infection
• on systemic steroid treatment
• on immunosuppressant treatment

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stage distribution of nasopharyngeal carcinoma at the time of diagnosis	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of nasopharyngeal carcinoma in screened negative group	5 years	Participants who are screened negative will be followed up yearly for 5 years after the screening. The incidence of NPC will be recorded.
Relative risk of developing nasopharyngeal carcinoma for subjects with positive test results	5 years	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.

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong