Lung CancerHANSENCT04913155
HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort
A study testing Low-dose CT screening in people with Lung Cancer, run by Hannover Medical School at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Low-dose CT screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,100 participants
- Where
- 3 sitesGermany
- Study dates
- 20 May 2021to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Patient's inability to fill in the questionnaire self-dependent
- Limited knowledge of the German language
- Inability to travel, residents of care facilities, etc.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, 22927
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort, Population-based Screening Study -Prospective, Randomized Comparator Controlled
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.
Read the 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:
- 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.
- Integration of access to a smoking cessation program.
- 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
- Being tested
- Low-dose CT screening
- Keywords
- Lung cancer, Screening program, Low-dose CT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose CT screeningRadiation
Low-dose computed tomography with lung nodule evaluation (LungRADS1.1, highrisk score group), randomized reporting of coronary artery calcium score and emphysema score
| Study group | Role | What they receive |
|---|---|---|
| Reporting group (coronary calcium score and emphysema score) | Other | Coronary calcium score and emphysema score are reported to subjects Receives: Radiation: Low-dose CT screening |
| Reporting group (coronary calcium score only) | Other | Only coronary calcium score is reported to subjects Receives: Radiation: Low-dose CT screening |
| Reporting group (emphysema score only) | Other | Only emphysema score is reported to subjects Receives: Radiation: Low-dose CT screening |
| Non-reporting group | Other | Coronary calcium score and emphysema score are not reported to subjects Receives: Radiation: Low-dose CT screening |
| Low-risk group | No intervention | No CT screening, collection of health data only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Positive predictive value (PPV) for lung cancer detection with different inclusion methods (NELSON vs. PLCO) after 2 screening rounds.
Measured: 5 years
Secondary outcomes (20)
Key secondary endpoint 1
Proportion of individuals selected for screening within the high-risk population.
Measured: 1 year
Key secondary endpoint 2
Proportion of lung cancers detected with different inclusion methods (NELSON vs. PLCO) within the overall study population after 5 years.
Measured: 5 years
Key secondary endpoint 3
Proportion of lung cancers detected with in the high-risk population after 5 years.
Measured: 5 years
Key secondary endpoint 4
Specificity within the overall population after 5-year follow-up.
Measured: 5 years
Key secondary endpoint 5
Sensitivity within the overall population after 5-year follow-up.
Measured: 5 years
Additional secondary endpoint 1
Rate of initiation of cardiovascular treatments (in particular lipid-lowering) in the calcium score reporting group vs. the non-reporting group after year 1 of study.
Measured: 1 year
Additional secondary endpoint 2
Efficiency of nodule management algorithms (LungRads1.1 + PanCan) will be evaluated according to the number of patients sorted in the category (a) "Next surveillance scan" AND the number of patients with lung cancer sorted into category (b) "early recall scan", or (c) "diagnostic evaluation".
Measured: 1 year
Additional secondary endpoint 3.1
Success of screening program. Based on all individuals enrolled. Definition of success is calculated using Response rate.
Measured: 1 year
Additional secondary endpoint 3.2
Success of screening program. Based on all individuals enrolled. Definition of success is calculated using Reliability of PLCO risk scoring (self-reported vs. on site assessment).
Measured: 1 year
Additional secondary endpoint 3.3
Success of screening program. Based on all individuals enrolled. Definition of success is calculated using Percentage of subjects receiving an adequate low-dose CT scan and report according to DRG guidelines (number of diagnostic CTs/number of all CTs).
Measured: 1 year
Additional secondary endpoint 3.4
Success of screening program. Based on all individuals enrolled. Definition of success is calculated using Percentage of subjects receiving adequate follow-up procedures.
Measured: 1 year
Additional secondary endpoint 4.1
Quality of screening program: CT reading performance (2nd reader vs. CAD vs. AI)
Measured: 1 year
Additional secondary endpoint 4.2
Quality of screening program: Quality of lung nodule management
Measured: 1 year
Additional secondary endpoint 4.3
Quality of screening program: Frequency of detection and management of incidental findings from low dose chest CT (emphysema, coronary heart disease, etc.)
Measured: 1 year
Additional secondary endpoint 4.4
Quality of screening program: LDCT dose management
Measured: 1 year
Additional secondary endpoint 5
Smoking cessation: Success of smoking cessation counseling based on number of participants quitting with or without revealing additional health risks (emphysema score, coronary calcium score or both).
Measured: 1 year
Additional secondary endpoint 6.1
Identification of blood-based biomarkers for early detection of lung tumors: Blood collection and evaluation of various blood-based epigenetic biomarkers in positive LDCT cases with subsequent biopsy on the positive predictive value of the LDCT test.
Measured: 1 year
Additional secondary endpoint 6.2
Identification of exhalation-based biomarkers for early detection of lung tumors: Collection of breath condensate and evaluation of various exhalation-based epigenetic biomarkers in positive LDCT cases with subsequent biopsy on the positive predictive value of the LDCT test.
Measured: 1 year
Additional secondary endpoint 7.1
Cost-effectiveness analysis: Main objectives of the modelling study are to investigate the impact of different components of LDCT lung cancer screening on the long-term all-cause mortality and cost-effectiveness. Key components include risk score-based selection criteria, nodule management protocols, threshold values of imaging biomarkers for cardio-vascular diseases and COPD, and inclusion of smoking cessation programs (performed by Center for Health Economics Research Hannover (CHERH).
Measured: 1 year
Additional secondary endpoint 7.2
Cost-effectiveness analysis: Comparison of patient recruitment strategies: Cost-effectiveness of register-based mailing campaign vs. GP referrals in terms of recruitment of qualified screening subjects (Center for Health Economics Research Hannover - CHERH).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start20 May 2021
- Primary completion1 Mar 2024
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Population-based Screening Study -Prospective, randomized comparator controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- LungenClinic Grosshansdorf, University Hospital Schleswig-Holstein, German Center for Lung Research
- Responsible party
- Sponsor
- Investigators
- Jens Vogel-Claussen, Prof. Dr., Study director, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913155
- Sponsor's protocol ID
- ESR-20-20770
- Acronym
- HANSE
- Status last verified
- Jul 2025
- First submitted
- 10 May 2021
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdo 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.
PubMed 42600771Vogel-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.
PubMed 41232542
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort, Population-based Screening Study -Prospective, Randomized Comparator Controlled
- ClinicalTrials.gov ID
- NCT04913155
- Acronym / sponsor ID
- HANSE / ESR-20-20770
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Screening program, Low-dose CT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12,100 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- LungenClinic Grosshansdorf, University Hospital Schleswig-Holstein, German Center for Lung Research
- Study start
- 20 May 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- Jan 2028 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Integration of access to a smoking cessation program.
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Population-based Screening Study -Prospective, randomized comparator controlled
| Arm | Type | Receives |
|---|---|---|
| Reporting group (coronary calcium score and emphysema score) | Other | Radiation: Low-dose CT screeningCoronary calcium score and emphysema score are reported to subjects |
| Reporting group (coronary calcium score only) | Other | Radiation: Low-dose CT screeningOnly coronary calcium score is reported to subjects |
| Reporting group (emphysema score only) | Other | Radiation: Low-dose CT screeningOnly emphysema score is reported to subjects |
| Non-reporting group | Other | Radiation: Low-dose CT screeningCoronary calcium score and emphysema score are not reported to subjects |
| Low-risk group | No intervention | –No CT screening, collection of health data only |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose CT screeningLow-dose computed tomography with lung nodule evaluation (LungRADS1.1, highrisk score group), randomized reporting of coronary artery calcium score and emphysema score | Radiation | Non-reporting group, Reporting group (coronary calcium score and emphysema score), Reporting group (coronary calcium score only), Reporting group (emphysema score only) |
Primary outcome
Primary endpoint
Time frame: 5 years
Positive predictive value (PPV) for lung cancer detection with different inclusion methods (NELSON vs. PLCO) after 2 screening rounds.
20 secondary outcomes
Key secondary endpoint 1
Time frame: 1 year
Key secondary endpoint 2
Time frame: 5 years
Key secondary endpoint 3
Time frame: 5 years
Key secondary endpoint 4
Time frame: 5 years
Key secondary endpoint 5
Time frame: 5 years
Additional secondary endpoint 1
Time frame: 1 year
Additional secondary endpoint 2
Time frame: 1 year
Additional secondary endpoint 3.1
Time frame: 1 year
Additional secondary endpoint 3.2
Time frame: 1 year
Additional secondary endpoint 3.3
Time frame: 1 year
Additional secondary endpoint 3.4
Time frame: 1 year
Additional secondary endpoint 4.1
Time frame: 1 year
Additional secondary endpoint 4.2
Time frame: 1 year
Additional secondary endpoint 4.3
Time frame: 1 year
Additional secondary endpoint 4.4
Time frame: 1 year
Additional secondary endpoint 5
Time frame: 1 year
Additional secondary endpoint 6.1
Time frame: 1 year
Additional secondary endpoint 6.2
Time frame: 1 year
Additional secondary endpoint 7.1
Time frame: 1 year
Additional secondary endpoint 7.2
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Derived from this study: PubMed 42600771Abdo 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.
- Derived from this study: PubMed 41232542Vogel-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.
- Study web page (German language)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Vogel-Claussen, Prof. Dr. study director
Hannover Medical School
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose CT screening in people with Lung Cancer, run by Hannover Medical School at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913155, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.