NCT04913155

HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort

HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort, Population-based Screening Study -Prospective, Randomized Comparator Controlled

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12,100 (estimated)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 55 Years – 79 Years
• Healthy volunteers: Accepted

Summary

The HANSE study is primarily intended as a pilot to provide evidence that a holistic and effective lung cancer screening program can be implemented in Germany and that such a screening program can be integrated in the current infrastructure of certified lung cancer centers.

Detailed description

Germany has a long history of offering screening programs for cancers, such as breast, colorectal, and, more recently, cervical and skin cancer. Screening for lung cancer, however, which causes more deaths than any other cancer in men and is the second leading cancer death in women (not far behind breast cancer), has not been implemented to date. Only very recently, Institute for Quality and Efficiency in Healthcare (IQWiG) in a preliminary assessment of low-dose CT screening, concluded that the benefits from screening outweigh potential risks. However, an implementation of a national lung cancer screening program, which would be covered by the general health insurance, will likely not be implemented before 2022. Nonetheless, the IQWiG report also comments on important criteria for implementing lung cancer screening in Germany using low-dose CT: 1. It would be necessary to determine criteria that define a high-risk population. Various risk forecasting models are currently being propagated to enable a more precise selection of high-risk individuals. Their reliability and repeatability needs to be checked. 2. Integration of access to a smoking cessation program. 3. Quality assurance measures must be taken into account, including standardized protocols for the evaluation of the CT images and the subsequent follow-up checks as well as the invasive diagnostic tissue sampling procedures. The HANSE study is primarily intended as a pilot to provide evidence that a holistic and effective lung cancer screening program can be implemented in Germany and that such a screening program can be integrated in the current infrastructure of certified lung cancer centers.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	Low-dose CT screening	Low-dose computed tomography with lung nodule evaluation (LungRADS1.1, highrisk score group), randomized reporting of coronary artery calcium score and emphysema score

Timeline

• Start date: 2021-05-20
• Primary completion: 2024-03-01
• Completion: 2028-01-01
• First posted: 2021-06-04
• Last updated: 2025-10-03

Locations

3 sites across 1 country: Germany