Utility of LDCT in Lung Cancer Screening in a TB Endemic Region

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study Assessing the Utility of Low-dose Computed Tomography (LDCT) in Lung Cancer Screening in North India

Conditions
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Lung Cancer

Intervention / Treatment
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* Diagnostic Test: Low-dose computed tomography of chest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LDCT arm<br>All eligible participants will undergo screening with LDCT | Diagnostic Test: Low-dose computed tomography of chest<br>* 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<br>* Other names: Low-dose CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positivity rate with LDCT screening | The proportion of participants with a positive result among the total number of individuals screened with LDCT | After baseline LDCT scan results are available (an average of 1 week after LDCT scan) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of detection of lung cancer | Rate of lung cancer detection among study participants | Up to 6 months after the LDCT scan | 
| False positive rate | Rate of false positive results with LDCT screening | Up to 6 months after the LDCT scan | 
| Proportion of patients requiring additional procedures (imaging/invasive procedures) | The proportion of patients with positive results on initial LDCT scan requiring additional procedures (imaging/invasive procedures) | Up to 6 months after the LDCT scan | 
| Proportion of patients developing complications due to additional procedures | The proportion of patients among those who developed complications due to additional procedures (imaging/invasive procedures) performed after initial LDCT scan | Up to 2 weeks after the diagnostic procedure | 
| Change in the 6-item Spielberger State-Trait Anxiety Inventory (STAI-6) questionnaire score | Change in anxiety levels from baseline after conveying LDCT results to the patient | After communication of baseline LDCT results (an average of 1-2 weeks after the LDCT scan) | 
| Cost in Indian Rupees to detect one case of lung cancer by LDCT screening | Cost-effectiveness of LDCT screening | Up to 6 months after the LDCT scan | 
| Proportion of patients who quit/re-initiated smoking after inclusion in study | The proportion of patients who quit/re-initiated smoking after inclusion in study | Up to 6 months after the LDCT scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, ldct, low-dose CT, screening, lung nodule