Back to resultsHANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort (HANSE)
Primary Purpose
Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Low-dose CT screening
Sponsored by
About this trial
This is an interventional screening trial for Lung Cancer focused on measuring Lung cancer, Screening program, Low-dose CT
Eligibility Criteria
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.
Sites / Locations
- Medizinische Hochschule HannoverRecruiting
- LungenClinic GrosshansdorfRecruiting
- Universitätsklinikum Schleswig-HolsteinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Other
Other
Other
No Intervention
Arm Label
Reporting group (coronary calcium score and emphysema score)
Reporting group (coronary calcium score only)
Reporting group (emphysema score only)
Non-reporting group
Low-risk group
Arm Description
Coronary calcium score and emphysema score are reported to subjects
Only coronary calcium score is reported to subjects
Only emphysema score is reported to subjects
Coronary calcium score and emphysema score are not reported to subjects
No CT screening, collection of health data only
Outcomes
Primary Outcome Measures
Primary endpoint
Positive predictive value (PPV) for lung cancer detection with different inclusion methods (NELSON vs. PLCO) after 2 screening rounds.
Secondary Outcome Measures
Key secondary endpoint 1
Proportion of individuals selected for screening within the high-risk population.
Key secondary endpoint 2
Proportion of lung cancers detected with different inclusion methods (NELSON vs. PLCO) within the overall study population after 5 years.
Key secondary endpoint 3
Proportion of lung cancers detected with in the high-risk population after 5 years.
Key secondary endpoint 4
Specificity within the overall population after 5-year follow-up.
Key secondary endpoint 5
Sensitivity within the overall population after 5-year follow-up.
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.
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".
Additional secondary endpoint 3.1
Success of screening program. Based on all individuals enrolled. Definition of success is calculated using Response rate.
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).
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).
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.
Additional secondary endpoint 4.1
Quality of screening program: CT reading performance (2nd reader vs. CAD vs. AI)
Additional secondary endpoint 4.2
Quality of screening program: Quality of lung nodule management
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.)
Additional secondary endpoint 4.4
Quality of screening program: LDCT dose management
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).
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.
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.
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).
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).
Full Information
NCT ID
NCT04913155
First Posted
May 10, 2021
Last Updated
June 8, 2021
Sponsor
Hannover Medical School
Collaborators
LungenClinic Grosshansdorf, University Hospital Schleswig-Holstein, German Center for Lung Research
1. Study Identification
Unique Protocol Identification Number
NCT04913155
Brief Title
HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort
Acronym
HANSE
Official Title
HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort, Population-based Screening Study -Prospective, Randomized Comparator Controlled
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
January 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School
Collaborators
LungenClinic Grosshansdorf, University Hospital Schleswig-Holstein, German Center for Lung Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, Screening program, Low-dose CT
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Population-based Screening Study -Prospective, randomized comparator controlled
Masking
Participant
Masking Description
Randomized reporting of coronary calcium score and emphysema score
Allocation
Randomized
Enrollment
12100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reporting group (coronary calcium score and emphysema score)
Arm Type
Other
Arm Description
Coronary calcium score and emphysema score are reported to subjects
Arm Title
Reporting group (coronary calcium score only)
Arm Type
Other
Arm Description
Only coronary calcium score is reported to subjects
Arm Title
Reporting group (emphysema score only)
Arm Type
Other
Arm Description
Only emphysema score is reported to subjects
Arm Title
Non-reporting group
Arm Type
Other
Arm Description
Coronary calcium score and emphysema score are not reported to subjects
Arm Title
Low-risk group
Arm Type
No Intervention
Arm Description
No CT screening, collection of health data only
Intervention Type
Radiation
Intervention Name(s)
Low-dose CT screening
Intervention Description
Low-dose computed tomography with lung nodule evaluation (LungRADS1.1, highrisk score group), randomized reporting of coronary artery calcium score and emphysema score
Primary Outcome Measure Information:
Title
Primary endpoint
Description
Positive predictive value (PPV) for lung cancer detection with different inclusion methods (NELSON vs. PLCO) after 2 screening rounds.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Key secondary endpoint 1
Description
Proportion of individuals selected for screening within the high-risk population.
Time Frame
1 year
Title
Key secondary endpoint 2
Description
Proportion of lung cancers detected with different inclusion methods (NELSON vs. PLCO) within the overall study population after 5 years.
Time Frame
5 years
Title
Key secondary endpoint 3
Description
Proportion of lung cancers detected with in the high-risk population after 5 years.
Time Frame
5 years
Title
Key secondary endpoint 4
Description
Specificity within the overall population after 5-year follow-up.
Time Frame
5 years
Title
Key secondary endpoint 5
Description
Sensitivity within the overall population after 5-year follow-up.
Time Frame
5 years
Title
Additional secondary endpoint 1
Description
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.
Time Frame
1 year
Title
Additional secondary endpoint 2
Description
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".
Time Frame
1 year
Title
Additional secondary endpoint 3.1
Description
Success of screening program. Based on all individuals enrolled. Definition of success is calculated using Response rate.
Time Frame
1 year
Title
Additional secondary endpoint 3.2
Description
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).
Time Frame
1 year
Title
Additional secondary endpoint 3.3
Description
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).
Time Frame
1 year
Title
Additional secondary endpoint 3.4
Description
Success of screening program. Based on all individuals enrolled. Definition of success is calculated using Percentage of subjects receiving adequate follow-up procedures.
Time Frame
1 year
Title
Additional secondary endpoint 4.1
Description
Quality of screening program: CT reading performance (2nd reader vs. CAD vs. AI)
Time Frame
1 year
Title
Additional secondary endpoint 4.2
Description
Quality of screening program: Quality of lung nodule management
Time Frame
1 year
Title
Additional secondary endpoint 4.3
Description
Quality of screening program: Frequency of detection and management of incidental findings from low dose chest CT (emphysema, coronary heart disease, etc.)
Time Frame
1 year
Title
Additional secondary endpoint 4.4
Description
Quality of screening program: LDCT dose management
Time Frame
1 year
Title
Additional secondary endpoint 5
Description
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).
Time Frame
1 year
Title
Additional secondary endpoint 6.1
Description
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.
Time Frame
1 year
Title
Additional secondary endpoint 6.2
Description
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.
Time Frame
1 year
Title
Additional secondary endpoint 7.1
Description
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).
Time Frame
1 year
Title
Additional secondary endpoint 7.2
Description
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).
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Vogel-Claussen, Prof. Dr.
Phone
+49 511 532 9817
Email
Vogel-Claussen.Jens@mh-hannover.de
First Name & Middle Initial & Last Name or Official Title & Degree
Heiko Hartleb
Phone
+49 641 94436 241
Email
heh@alcedis.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Vogel-Claussen, Prof. Dr.
Organizational Affiliation
Hannover Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Vogel-Claussen, Prof. Dr.
Phone
+49 511 532 9817
Email
Vogel-Claussen.Jens@mh-hannover.de
Facility Name
LungenClinic Grosshansdorf
City
Großhansdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Reck, Prof. Dr.
Phone
+49 4102 601 2101
Email
M.Reck@lungenclinic.de
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Bohnet, Dr.
Phone
+49 451 500 45003
Email
Sabine.Bohnet@uksh.de
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.hanse-lungencheck.de
Description
Study web page (German language)
Learn more about this trial
HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort
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