Prospective Nasopharyngeal Carcinoma Screening Using Plasma Epstein-Barr Virus DNA Analysis
Study Details
Study Description
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 down-staging of the NPC cases in asymptomatic individuals.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age 40 to 62 years
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ethnic Chinese
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male
Exclusion Criteria:
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history of nasopharyngeal carcinoma
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currently having a malignant disease
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active autoimmune disease
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HIV infection
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on systemic steroid treatment
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on immunosuppressant treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinese University of Hong Kong | Hong Kong | Hong Kong |
Sponsors and Collaborators
- Chinese University of Hong Kong
Investigators
- Principal Investigator: Kwan-chee Allen Chan, MD, PhD, Chinese University of Hong Kong
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- CU-ChemPath-001