Prospective 20,000-person Nasopharyngeal Carcinoma (NPC) Screening Programme Using Plasma Epstein-Barr Virus (EBV) DNA Analysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20,302
- 试验地点
- 1
- 主要终点
- Stage distribution of nasopharyngeal carcinoma at the time of diagnosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 62 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age 40 to 62 years
- •ethnic Chinese
排除标准
- •history of nasopharyngeal carcinoma
- •currently having a malignant disease
- •active autoimmune disease
- •HIV infection
- •on systemic steroid treatment
- •on immunosuppressant treatment
结局指标
主要结局
Stage distribution of nasopharyngeal carcinoma at the time of diagnosis
时间窗: 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.
次要结局
- Relative risk of developing nasopharyngeal carcinoma for subjects with positive test results(5 years)
- Incidence of nasopharyngeal carcinoma in screened negative group(5 years)
研究者
Allen Chan
Professor
Chinese University of Hong Kong