A community-based 2-arm cluster randomized trial to compare universal FIT testing versus target (risk assessment done) FIT testing for Early onset colorectal cancer (EOCRC) in India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,200
- 试验地点
- 1
- 主要终点
- We will assess the hypothesis that implementing a risk assessment tool, followed by communicating the identified risk, will increase the proportion of individuals in the camp who return a FIT test (FIT-target), compared to those in the camp where individuals are offered a FIT test without risk assessment or communication of risk (FIT-general).
研究概览
简要总结
Although traditionally regarded as a low-incidence region, India has experienced a rapid rise in EOCRC incidence in the last few years. The Delhi State Cancer Institute recently reported that an astonishing 60% of their CRC patients were aged <50 years, with younger patients more often diagnosed at an advanced stage. In 2019 data from a separate center, the mean age of diagnosis among 970 CRC patients was 47.5 years, with 35% of newly diagnosed CRC patients being under the age of 40.1 This trend reflects global trends with most low- and middle-income countries experiencing a dramatic rise in EOCRC, mimicking that which began over a decade prior in high-income countries. Currently, there are no population-level screening guidelines for CRC in India, and it is unclear if data around efficacy and optimal screening age derived from Western countries can be extrapolated to India. Thus, the present juncture is an opportune time to initiate community- based trials in India to not only measure the rapid acceleration CRC incidence, but also identify effective strategies for intervention, including assessing the impact of population-based CRC screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Healthy Participants above 18 years of age.
- •Participants who are willing to volunatrily give informed consent.
- •Participants who are residents of Chhattisgarh and kerala.
排除标准
- •Participants who are less than 18 years.
- •Participants with a diagnosis or past history of colorectal cancer.
- •Patients actively being treated for colorectal cancer.
- •Participants with an inability to provide informed consent.
结局指标
主要结局
We will assess the hypothesis that implementing a risk assessment tool, followed by communicating the identified risk, will increase the proportion of individuals in the camp who return a FIT test (FIT-target), compared to those in the camp where individuals are offered a FIT test without risk assessment or communication of risk (FIT-general).
时间窗: 156 weeks
次要结局
- We will evaluate the hypothesis that the screening camp where individuals are identified as high-risk by the risk assessment tool will also have a higher likelihood of having an adenoma and CRC, among those aged more than 50 years(156 Weeks)
研究者
Dr Bhawna Sirohi
Vedanta Medical Research Foundation
