NCT04627350

Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,200 (estimated)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 55 Years – 74 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate and optimize entry criteria for the proposed programme for early detection of lung cancer in the Czech Republic. An estimated 3200 high-risk (age 55-74 years, \>30 pack-years) asymptomatic individuals will undergo baseline low-dose chest CT (LDCT) and a follow-up LDCT at 1 year. Patients with poor performance status (PS) 2-4, history of malignancy in the past 10 years, chest CT in the past 1 year, bodyweight \>140kg will not be included. The patients will fill out a questionnaire with basic data, including smoking history (pack-years), history of previous malignancy, CT imaging of the thorax, and will undergo spirometry. Outcomes of the study include: * optimization of entry criteria, optimization of timing of a follow-up LDCT and management of the patients, proposal of quality assurance indicators * influence of screening on the stage of lung cancer at the time of the diagnosis and life-years lost * cost-effectiveness of the screening program * evaluation of the diagnostic yield for secondary findings (pulmonary fibrosis, cardiovascular risk)

Conditions

• Lung Cancer

Interventions

Type	Name	Description
OTHER	Response to pulmonary finding (nodule, mass)	Follow-up low-dose CT, PET-CT, tissue sampling (transparietal biopsy, bronchoscopy, resection), contrast-enhanced CT of the thorax

Timeline

• Start date: 2020-08-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-11-13
• Last updated: 2020-11-13

Locations

1 site across 1 country: Czechia