A single-arm observational study to characterize the demographic, clinical features and outcomes of a Brazilian cohort of patients with lung cancer.
Main hypothesis: The tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease could leads to an increase in the proportion of false-positive cases resulting in unnecessary medical procedures, which represents a waste of resources and a risk for patients. Main objective: To assess whether the percentage of false-positive cases with indication of biopsy after lung cancer screening with low-dose CT in high-risk smokers in a population with a high prevalence of granulomatous disease will be within the expected range according to other studies in the literature. As there is robust evidence of the effectiveness of screening in reducing mortality from lung cancer, we expect the project to bring benefits to patients treated for image-detected lung cancer in the project, with reduced staging and a shorter time between diagnosis and treatment. Therefore , although the focus is on the safety of screening, the project will also monitor the cancer detection rate, which is a surrogate endpoint of effectiveness.
Study Type
OBSERVATIONAL
Enrollment
477
Research Site
Rio de Janeiro, Brazil
• Proportion of negative cases on screening according to the Lung-RADS classification.
Tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease may increase the proportion of false-positive cases, leading to unnecessary medical procedures, resource waste, and patient risk. This epidemiological scenario may also result in an increase in cases classified as benign or probably benign in screening.
Time frame: Last 10 years
• Proportion of false-positives.
Tomographic screening for lung cancer in a population with a high prevalence of granulomatous disease may increase the proportion of false-positive cases, leading to unnecessary medical procedures, resource waste, and patient risk. This epidemiological scenario may also result in an increase in cases classified as benign or probably benign in screening.
Time frame: Last 10 years
• Cancer detection rate.
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Time frame: last 10 years
• Willingness to be screened (ie, proportion of eligible patients actually signing up for the study)
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Time frame: Last 10 years
• Percentage of adherence to screening - calculated by dividing the number of individuals screened with LDCT (numerator) by the number of eligible individuals invited to screen (denominator).
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Time frame: Last 10 years
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• Percentage of adherence to follow-up.
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Time frame: Last 10 years
• Prevalence of granulomatous disease in screening positive cases
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Time frame: Last 10 years
• Prevalence of incidental findings.
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Time frame: Last 10 years
• Prevalence of clinically relevant incidental findings that required follow-up.
Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature.
Time frame: Last 10 years