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

October 13, 2022 updated by: Allen Chan, Chinese University of Hong Kong

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Nasopharyngeal Carcinoma

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 Type

Observational

Enrollment (Actual)

20302

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Hong Kong
- - Hong Kong, Hong Kong
    - Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 62 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male Hong Kong residents of Chinese ethnicity

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage distribution of nasopharyngeal carcinoma at the time of diagnosis Time Frame: 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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of nasopharyngeal carcinoma in screened negative group Time Frame: 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.	5 years
Relative risk of developing nasopharyngeal carcinoma for subjects with positive test results Time Frame: 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.	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

Principal Investigator: Kwan-chee Allen Chan, MD, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

August 1, 2016

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria