NCT04913155Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 12100 (estimated)
- First submitted
- 10 May 2021
- Start date
- 20 May 2021
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- Hannover Medical School
- Diseases
- Lung cancer
- NCT number
- NCT04913155
What you commit to
- Study type: Interventional
- Planned participants: 12100
- From 20 May 2021 to the primary completion date, 1 Mar 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 55 years to 79 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LungenClinic Grosshansdorf Coordinator of this site? Confirm its status | Großhansdorf | Germany | Unknown status |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Universitätsklinikum Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
Related publications
- Integrating Quantitative CT Scan Biomarkers to Enhance COPD Detection in the Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort Lung Cancer Screening Program.Chest · 2026 · PMID 42600771
- Effectiveness of NELSON versus PLCOm2012 lung cancer screening eligibility criteria in Germany (HANSE): a prospective cohort study.Lancet Oncol · 2025 · PMID 41232542
This page is information, not medical advice. Discuss any trial with your doctor.