Evaluating the effectiveness of low-dose CT based lung cancer screening among high-risk individuals and availability and impact of lung cancer care pathways
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,716
- 试验地点
- 1
- 主要终点
- Screen positive rate for LDCT in the early detection of lung cancer in a high-risk Indian population
研究概览
简要总结
The GLOBOCAN 2022 report for India, suggests lung cancer as the second most frequent cancer in males, with a case count at 58,970 forming 8.5% of the entire cancer burden for males in India. Upon including females, lung cancer still figures in the top five (ranked 4th) most frequent cancers in the country with 81,748 cases which is 5.8% of the entire case load of cancer in India. LDCT is the only test to screen for lung cancer recommended by various associations including USPSTF for the high-risk smokers in 50-80 years. There is no conclusive data on the efficacy of LDCT in screening lung cancer in the Indian population and the care pathways which might exist for individuals so diagnosed. There is a severe lack of evidence in accounting for the utility of LDCT in screening lung cancer in India, which is largely formed by underpowered retrospective results. This study will employ a prospective, cohort design in order to evaluate the efficacy of LDCT screening for lung cancer in a high-risk Indian population. The subject will receive a relevant and prompt Multidisciplinary team (MDT) referral if any LDCT scan is found to raise suspicions for cancer. The effective management of lung cancer relies heavily on timely diagnosis, streamlined care pathways and coordinated multidisciplinary treatment approaches. This project also aims to systematically evaluate the existence or absence of formalized care pathways for lung cancer patients within the Indian healthcare system, as part of a broader initiative assessing LDCT screening utility. The project will explore the current referral systems, diagnostic workflows, multidisciplinary team involvement, treatment initiation processes, and follow-up mechanisms. By mapping these pathways, the study will identify key bottlenecks, gaps, and regional disparities affecting patient journeys from suspicion or diagnosis through treatment and survivorship
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •a) 50 to 80 years b) Male and Female c) Individuals with a history of smoking at least 20 pack-years, either current smokers or those who quit within the last 15 years.
排除标准
- •a) Never-smokers, defined as those who smoked fewer than 100 cigarettes in their lifetime b) Individuals currently receiving treatment for active cancer.
结局指标
主要结局
Screen positive rate for LDCT in the early detection of lung cancer in a high-risk Indian population
时间窗: 0, 12, 24 months
次要结局
- Presence & impact of care pathways for patients screened for lung cancer(12 months)
研究者
Dr Abhishek Shankar
All India Institute of Medical Sciences
