Clinical trial NCT04913155: HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort
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
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
Screening program
Low-dose CT
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: LungenClinic Grosshansdorf
name: University Hospital Schleswig-Holstein
name: German Center for Lung Research
First posted: 2021-06-04
Enrollment: 12100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Population-based Screening Study -Prospective, randomized comparator controlled
Primary purpose: SCREENING

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:

1. 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.
2. Integration of access to a smoking cessation program.
3. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary endpoint
timeFrame: 5 years
Secondary outcomes:
measure: Key secondary endpoint 1
timeFrame: 1 year
measure: Key secondary endpoint 2
timeFrame: 5 years
measure: Key secondary endpoint 3
timeFrame: 5 years
measure: Key secondary endpoint 4
timeFrame: 5 years
measure: Key secondary endpoint 5
timeFrame: 5 years
measure: Additional secondary endpoint 1
timeFrame: 1 year
measure: Additional secondary endpoint 2
timeFrame: 1 year
measure: Additional secondary endpoint 3.1
timeFrame: 1 year
measure: Additional secondary endpoint 3.2
timeFrame: 1 year
measure: Additional secondary endpoint 3.3
timeFrame: 1 year
measure: Additional secondary endpoint 3.4
timeFrame: 1 year
measure: Additional secondary endpoint 4.1
timeFrame: 1 year
measure: Additional secondary endpoint 4.2
timeFrame: 1 year
measure: Additional secondary endpoint 4.3
timeFrame: 1 year
measure: Additional secondary endpoint 4.4
timeFrame: 1 year
measure: Additional secondary endpoint 5
timeFrame: 1 year
measure: Additional secondary endpoint 6.1
timeFrame: 1 year
measure: Additional secondary endpoint 6.2
timeFrame: 1 year
measure: Additional secondary endpoint 7.1
timeFrame: 1 year
measure: Additional secondary endpoint 7.2
timeFrame: 1 year
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Großhansdorf
country: Germany
facility: LungenClinic Grosshansdorf
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: Hannover Medical School
name: Jens Vogel-Claussen, Prof. Dr.
role: STUDY_DIRECTOR
References: