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

  • STATUS
    Recruiting
  • End date
    Jan 17, 2028
  • participants needed
    12100
  • sponsor
    Hannover Medical School
Updated on 17 June 2021
cancer
lung cancer
emphysema
lung cancer screening
lung carcinoma

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.

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.

Details
Condition Pulmonary Disease, Lung Neoplasm, Bronchial Neoplasm, Lung Cancer, carcinoma lung, lung carcinoma
Treatment Low-dose CT screening
Clinical Study IdentifierNCT04913155
SponsorHannover Medical School
Last Modified on17 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female subjects aged 55-79 years
Current or former smokers
Subjects with calculated risk score PLCOM2012 1.58% (6 yrs.) or NELSON inclusion criteria (current or former smokers [those who had quit 10 years ago] who had smoked >15 cigarettes a day for >25 years or >10 cigarettes a day for >30 years)
Able and willing to give written informed consent In addition, non-qualifying subjects fulfilling inclusion criteria 1 (age), 2 (smoking history) and 4 (consent), but do not meet the inclusion criterion 3 (risk too low) will be asked to volunteer by contributing long-term outcome data informing of the development of lung cancer or death from lung cancer (about n=7100 randomly selected from all 3 centers, low-risk group). These subjects will be contacted via mail after a minimum of 5 year follow up to inquire if they developed lung cancer in the time between their recruitment and present. Non-responders will be followed by local registries and by phone. New lung cancer cases will be verified using official hospital or cancer registry documents

Exclusion Criteria

Comorbidity, which would unequivocally contraindicate either screening or treatment if lung cancer is detected
History of chest CT within the past year preceding the invitation
Inability to undergo non-contrast CT (e.g. 200 kg body weight, inability to lie flat)
Pregnancy
Risk of non-compliance with study procedures
Unable to give written consent
Patient's inability to fill in the questionnaire self-dependent
Limited knowledge of the German language
Inability to travel, residents of care facilities, etc
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