NCT07279948

A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort of Patients With Lung Cancer.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 477 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A single-arm observational study to characterize the demographic, clinical features and outcomes of a Brazilian cohort of patients with lung cancer.

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.

Conditions

• Lung Cancer

Timeline

• Start date: 2026-05-30
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2025-12-12
• Last updated: 2026-03-16

Locations

1 site across 1 country: Brazil