Lung Cancer
Conditions
Brief summary
A prospective, longitudinal, single-arm interventional study of lung cancer screening.
Detailed description
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
In order, to be eligible for the study, patients must fulfill all the following inclusion criteria: * Age between ≥50 and ≤80 years. * Be a current smoker or have quit 15 years ago or less. * Have participated or are currently participating in smoking cessation program. * Lifetime smoking exposure equal to or greater than 20 pack-year. * Provided signed informed consent (ICF)
Exclusion criteria
* In order, to be exclude for the study, patients must at least one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • Proportion of negative cases on screening according to the Lung-RADS classification. | Last 10 years | 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. |
| • Proportion of false-positives. | Last 10 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Cancer detection rate. | last 10 years | Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature. |
| • Willingness to be screened (ie, proportion of eligible patients actually signing up for the study) | Last 10 years | Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature. |
| • 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). | Last 10 years | Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature. |
| • Percentage of adherence to follow-up. | Last 10 years | Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature. |
| • Prevalence of granulomatous disease in screening positive cases | Last 10 years | Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature. |
| • Prevalence of incidental findings. | Last 10 years | Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature. |
| • Prevalence of clinically relevant incidental findings that required follow-up. | Last 10 years | Not Applicable (N/A). The findings of each outcome will be compared with results published in the scientific literature. |
Countries
Brazil
Contacts
CONTACTAstraZeneca Clinical Study Information Center
PRINCIPAL_INVESTIGATORArn Migowski Rocha dos Santos
Instituto Nacional de Câncer
Outcome results
None listed