Clinical trial · Interventional
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
NCT04913155CI-TRIAL-00096230HANSEactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-dose CT screening | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- OTHER
- label
- Reporting group (coronary calcium score and emphysema score)
- description
- Coronary calcium score and emphysema score are reported to subjects
- interventionNames
- Radiation: Low-dose CT screening
- type
- OTHER
- label
- Reporting group (coronary calcium score only)
- description
- Only coronary calcium score is reported to subjects
- interventionNames
- Radiation: Low-dose CT screening
- type
- OTHER
- label
- Reporting group (emphysema score only)
- description
- Only emphysema score is reported to subjects
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male and female subjects aged 55-79 years 2. Current or former smokers 3. 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). 4. 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: 1. Comorbidity, which would unequivocally contraindicate either screening or treatment if lung cancer is detected. 2. History of chest CT within the past year preceding the invitation. 3. Inability to undergo non-contrast CT (e.g. ≥ 200 kg body weight, inability to lie flat). 4. Pregnancy 5. 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.
References
Publications (2)
- DERIVEDAbdo M, Pott H, Reck M, Martin R, Bollmann BA, Bohnet S, May K, Dettmer S, Schmid-Bindert G, Watz H, Vogel-Claussen J; HANSE Trial Group. 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 Aug 14:S0012-3692(26)06346-4. doi: 10.1016/j.chest.2026.07.5237. Online ahead of print. PMID 42600771
- DERIVEDVogel-Claussen J, Bollmann BA, May K, Stiebeler S, Dettmer S, Faron A, Kuhlmann A, Schmid-Bindert G, Kaaks R, Barkhausen J, Bohnet S, Reck M; HANSE investigators. Effectiveness of NELSON versus PLCOm2012 lung cancer screening eligibility criteria in Germany (HANSE): a prospective cohort study. Lancet Oncol. 2025 Dec;26(12):1541-1551. doi: 10.1016/S1470-2045(25)00490-5. Epub 2025 Nov 10. PMID 41232542