Status:
ACTIVE_NOT_RECRUITING
HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
LungenClinic Grosshansdorf
University Hospital Schleswig-Holstein
Conditions:
Lung Cancer
Eligibility:
All Genders
55-79 years
Phase:
NA
Brief 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 ...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
12100 Patients enrolled
Trial Details
Trial ID
NCT04913155
Start Date
May 20 2021
End Date
January 1 2028
Last Update
October 2 2025
Active Locations (3)
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1
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
2
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, Germany, 22927
3
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany, 23538