Clinical trial NCT02063399: Prospective Nasopharyngeal Carcinoma Screening Using Plasma Epstein-Barr Virus DNA Analysis
Official title: Prospective 20,000-person Nasopharyngeal Carcinoma (NPC) Screening Programme Using Plasma Epstein-Barr Virus (EBV) DNA Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Keywords: NPC
Cancer screening
Plasma EBV DNA
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 20302
Sex: MALE
Minimum age (years): 40
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male Hong Kong residents of Chinese ethnicity

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stage distribution of nasopharyngeal carcinoma at the time of diagnosis
timeFrame: 3 years
Secondary outcomes:
measure: Incidence of nasopharyngeal carcinoma in screened negative group
timeFrame: 5 years
measure: Relative risk of developing nasopharyngeal carcinoma for subjects with positive test results
timeFrame: 5 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Kwan-chee Allen Chan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.