Design and Rationale of the HANSE Study: A Holistic German Lung Cancer Screening Trial Using Low-Dose Computed...

Area of Science:

• Pulmonology
• Radiology
• Public Health

Background:

• Lung cancer has high prevalence and mortality globally.
• Low-dose computed tomography (LDCT) effectively reduces lung cancer mortality.
• Germany currently lacks a national lung cancer screening program despite recommendations.

Purpose of the Study:

• To address key questions for implementing an effective national lung cancer screening program in Germany.
• To compare the NELSON and PLCO_M2012 risk assessment scores for optimal high-risk participant identification.
• To evaluate a holistic screening approach integrating LDCT, risk scores, emphysema, and coronary calcium scoring.

Main Methods:

• The HANSE study enrolls 5000 high-risk and 7100 low-risk individuals (current/former smokers, aged 55-79).
• High-risk participants undergo baseline and 12-month LDCT screening.
• Lung nodules are analyzed using a modified Lung-RADS 1.1 score; emphysema and coronary calcium are also assessed.

Main Results:

• The study assesses the sensitivity and specificity of risk assessments and LDCT screening.
• It evaluates the impact of randomized LDCT reporting and the efficiency of lung nodule management.
• Long-term follow-up (up to 10 years) will analyze the overall success and quality of the screening program.

Conclusions:

• The HANSE study provides crucial data for establishing a quality-controlled national lung cancer screening program in Germany.
• It aims to optimize procedural aspects, risk stratification, and integrated health assessments for a comprehensive screening strategy.