Postgraduate Institute of Medical Education and Research (PGIMER)
Chandigarh, 160012, India
NCT Number: NCT03909620
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.
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Notify Me50 year–74 year
All sexes
Interventional
Not applicable
Chandigarh, 160012, India
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: LDCT, Low-dose CT
Time frame: 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
Time frame: Up to 6 months after the LDCT scan
Rate of lung cancer detection among study participants
Time frame: Up to 6 months after the LDCT scan
Rate of false positive results with LDCT screening
Time frame: Up to 6 months after the LDCT scan
The proportion of patients with positive results on initial LDCT scan requiring additional procedures (imaging/invasive procedures)
Time frame: Up to 2 weeks after the diagnostic procedure
The proportion of patients among those who developed complications due to additional procedures (imaging/invasive procedures) performed after initial LDCT scan
Time frame: After communication of baseline LDCT results (an average of 1-2 weeks after the LDCT scan)
Change in anxiety levels from baseline after conveying LDCT results to the patient
Time frame: Up to 6 months after the LDCT scan
Cost-effectiveness of LDCT screening
Time frame: Up to 6 months after the LDCT scan
The proportion of patients who quit/re-initiated smoking after inclusion in study
Post Graduate Institute of Medical Education and Research, Chandigarh
Other
A Study Assessing the Utility of Low-dose Computed Tomography (LDCT) in Lung Cancer Screening in North India
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