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NCT02063399 Clinical Trial

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 Details — Status: Active, not recruiting

Administrative data
NCT number NCT02063399
Other study ID # CU-ChemPath-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2013
Est. completion date June 2023

Study information
Verified date October 2022
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20302
Est. completion date June 2023
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 40 Years to 62 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Hong Kong Chinese University of Hong Kong Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

Chan KC, Hung EC, Woo JK, Chan PK, Leung SF, Lai FP, Cheng AS, Yeung SW, Chan YW, Tsui TK, Kwok JS, King AD, Chan AT, van Hasselt AC, Lo YM. Early detection of nasopharyngeal carcinoma by plasma Epstein-Barr virus DNA analysis in a surveillance program. Cancer. 2013 May 15;119(10):1838-44. doi: 10.1002/cncr.28001. Epub 2013 Feb 21. — View Citation

Lo YM, Chan LY, Lo KW, Leung SF, Zhang J, Chan AT, Lee JC, Hjelm NM, Johnson PJ, Huang DP. Quantitative analysis of cell-free Epstein-Barr virus DNA in plasma of patients with nasopharyngeal carcinoma. Cancer Res. 1999 Mar 15;59(6):1188-91. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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