Prospective Nasopharyngeal Carcinoma Screening Using Plasma Epstein-Barr Virus DNA Analysis
NCT ID: NCT02063399
Last Updated: 2022-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20302 participants
OBSERVATIONAL
2013-07-31
2023-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* ethnic Chinese
* male
Exclusion Criteria
* currently having a malignant disease
* active autoimmune disease
* HIV infection
* on systemic steroid treatment
* on immunosuppressant treatment
40 Years
62 Years
MALE
Yes
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Allen Chan
Professor
Principal Investigators
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Kwan-chee Allen Chan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Chinese University of Hong Kong
Hong Kong, , Hong Kong
Countries
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References
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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.
Chan KCA, Lam WKJ, King A, Lin VS, Lee PPH, Zee BCY, Chan SL, Tse IOL, Tsang AFC, Li MZJ, Jiang P, Ai QYH, Poon DMC, Au KH, Hui EP, Ma BBY, Van Hasselt AC, Chan ATC, Woo JKS, Lo YMD. Plasma Epstein-Barr Virus DNA and Risk of Future Nasopharyngeal Cancer. NEJM Evid. 2023 Jul;2(7):EVIDoa2200309. doi: 10.1056/EVIDoa2200309. Epub 2023 Jun 27.
Chan KCA, Woo JKS, King A, Zee BCY, Lam WKJ, Chan SL, Chu SWI, Mak C, Tse IOL, Leung SYM, Chan G, Hui EP, Ma BBY, Chiu RWK, Leung SF, van Hasselt AC, Chan ATC, Lo YMD. Analysis of Plasma Epstein-Barr Virus DNA to Screen for Nasopharyngeal Cancer. N Engl J Med. 2017 Aug 10;377(6):513-522. doi: 10.1056/NEJMoa1701717.
Other Identifiers
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CU-ChemPath-001
Identifier Type: -
Identifier Source: org_study_id
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