A Study Assessing the Utility of Low-dose Computed Tomography (LDCT) in Lung Cancer Screening in North India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 2
- 主要终点
- Positivity rate with LDCT screening
研究概览
简要总结
Lung cancer screening with low-dose computed tomography (LDCT) has been recently shown to result in a significant reduction in lung cancer-specific mortality. However, the utility of LDCT screening in developing countries with high incidence of tuberculosis has not been adequately studied. The investigators hypothesize that LDCT screening in tuberculosis endemic regions is likely to yield a large proportion of false-positive results, especially in the initial round of screening, posing a significant burden on the healthcare system. Herein, the investigators assess the utility of LDCT and its cost-effectiveness in India.
详细描述
Screening for lung cancer may reduce lung cancer mortality by diagnosing the disease at an early stage when it is treatable more effectively. There are several methods available for screening of lung cancer. These include sputum cytology, chest radiography, computed tomography (CT) of the chest, and positron emission tomography (PET). However, sputum cytology and chest radiography have been found to be ineffective as screening tests for lung cancer as there is no reduction in lung cancer mortality. The use of CT or PET for lung cancer screening may be associated with unacceptable levels of radiation exposure and enormous cost.
Low-dose computed tomography (LDCT) of the chest is a special type of CT, which uses relatively low radiation exposure to create a low-resolution image of the entire thorax. The radiation exposure associated with LDCT is 5-6 times less than that of a conventional CT scan of the thorax. LDCT screening has been to shown to result in a 20% reduction in lung cancer-specific mortality. Several national and international guidelines recommend this strategy for lung cancer screening.
Despite these guidelines and recommendations by several organizations, lung cancer screening has not been established in several developing countries, where a controversy arises due to high rates of granulomatous diseases like tuberculosis. Emerging evidence indicates that false positive results with LDCT in developing countries may not be unacceptably high as previously believed.
In this study, the investigators intend to assess the utility of lung cancer screening using low-dose computed tomography (LDCT) in India, a country with high prevalence of tuberculosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 55-74 years with at least 30 pack-year history of smoking (or smoking index ≥600) who are current smokers or quit within the last 15 years OR
- •Individuals aged 50-74 years with at least 20 pack-year history of smoking (or smoking index ≥400) who are current or former smokers with COPD or family history of lung cancer in any first-degree relative
排除标准
- •Symptomatic structural lung disease other than COPD (e.g. bronchiectasis, chronic pulmonary aspergillosis, pulmonary fibrosis)
- •Severe comorbid condition which is likely to limit the survival of the patient in the opinion of the investigator (e.g. advanced lung disease, cardiovascular disease, chronic kidney disease, chronic liver disease)
- •Presence of symptoms which lead to a suspicion of lung cancer (e.g. hemoptysis or unexplained weight loss [>5 kg] within the last 6 months)
- •Conditions which may interfere interpretation of CT (e.g. metallic implants on chest wall, cardiac pacemakers)
- •Treatment for any other cancer in the last 5 years
- •Pulmonary infection (for which treatment with antimicrobials is indicated) which is active at present or was recent (within the last 3 months)
- •Patients who have underwent CT chest within the last 18 months
- •Negative consent
结局指标
主要结局
Positivity rate with LDCT screening
时间窗: After baseline LDCT scan results are available (an average of 1 week after LDCT scan)
The proportion of participants with a positive result among the total number of individuals screened with LDCT
次要结局
- False positive rate(Up to 6 months after the LDCT scan)
- Proportion of patients developing complications due to additional procedures(Up to 2 weeks after the diagnostic procedure)
- Rate of detection of lung cancer(Up to 6 months after the LDCT scan)
- Proportion of patients who quit/re-initiated smoking after inclusion in study(Up to 6 months after the LDCT scan)
- Proportion of patients requiring additional procedures (imaging/invasive procedures)(Up to 6 months after the LDCT scan)
- Cost in Indian Rupees to detect one case of lung cancer by LDCT screening(Up to 6 months after the LDCT scan)
- Change in the 6-item Spielberger State-Trait Anxiety Inventory (STAI-6) questionnaire score(After communication of baseline LDCT results (an average of 1-2 weeks after the LDCT scan))
研究者
Dr. Navneet Singh
Additional Professor, Department of Pulmonary Medicine
Post Graduate Institute of Medical Education and Research, Chandigarh