A Cluster Randomized Controlled Screening Trial for Nasopharyngeal Carcinoma in Southern China (CRCSTNPC Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 87,600
- 试验地点
- 2
- 主要终点
- Mortality rate of NPC at 12 years by intervention group
研究概览
简要总结
This study is aimed to estimate the effectiveness of an Epstein-Barr virus (EBV) serology-based screening program to reduce nasopharyngeal carcinoma (NPC) mortality in a cluster randomized controlled trial in an NPC high-risk population. Sixteen towns in Sihui and Zhongshan Cities, China will be selected, with eight allocated to the screening group and eight to the control group. Cantonese residents aged 30-69 years with no history of NPC will be included. Residents in the screening towns will be invited to undergo serum EBV VCA/EBNA1 IgA antibody tests.
详细描述
Nasopharyngeal carcinoma (NPC) has a high prevalence in southern China. Sihui and Zhongshan cities are located along the Pearl River in Guangdong Province, China, and are well known for a high incidence of NPC worldwide. During the last 20 years, Screening for NPC has been demonstrated to increase the early detection rate of NPC in endemic regions. It is well shown that the effect of Epstein-Barr virus (EBV) serological antibodies is elevated several years before NPC diagnosis; therefore, EBV antibodies have been considered screening markers for NPC. However, none of the studies have reported the impact of screening on NPC-specific mortality.
This study aims to launch a cluster-randomized screening trial with combined VCA/IgA and EBNA1/IgA measurement by ELISA as the primary screening method in these 2 cities to examine the impact of EBV serological screening on NPC-specific mortality. Residents aged 30-69 years in eight screening towns in the intervention group will be invited to EBV antibody tests-IgA antibodies to EBV VCA/IgA and EBV nuclear antigen-1 (EBNA1/IgA) by ELISA. The primary objective of this trial is to assess an estimate of the EBV serological antibody-based screening for NPC on NPC-specific in the populations with a high incidence of NPC
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria 1) the town located in Sihui or Zhongshan city; 2) the town established a tertiary cancer prevention network; 3) the medical staff in the town hospitals agreed to take part in.
排除标准
- •having conducted NPC screening program.
- •Individuals
- •Inclusion criteria 1) being aged 30-69 years; 2) being Cantonese; 3) having signed the informed consent; 4) having an Eastern Cooperative Oncology Group score of 0-2; and 5) having a good physical or psychological condition and consciousness.
- •Exclusion criteria 1) having prevalent NPC.
结局指标
主要结局
Mortality rate of NPC at 12 years by intervention group
时间窗: December, 2019
NPC mortality rate will be compared between screening group and control group at 12-year follow-up.
次要结局
- Stage distribution at diagnosis for NPC patients by intervention group(December, 2019)
- Cost-effectiveness(December, 2019)
- All-cause mortality at 12 years by intervention group(December, 2019)
- NPC incidence at 12 years by intervention group(December, 2019)
- NPC overall survival by cases from the two intervention groups(December, 2019)
研究者
Hong Ming-huang
Professor
Sun Yat-sen University