Utility of LDCT in Lung Cancer Screening in a TB Endemic Region
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Low-dose computed tomography of chest
Intervention type(s): Diagnostic Test
Intervention description(s): Eligible subjects will undergo a single round of LDCT screening. The LDCT will be considered as positive if a solid nodule or part-solid nodule of size ≥6 mm or non-solid nodule of size ≥20 mm is identified. Evaluation of positive nodules will be performed as per existing standard recommendations
Other intervention name(s): LDCT; Low-dose CT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: lung cancer; ldct; low-dose CT; screening; lung nodule