HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort

N/AActive Not RecruitingNCT04913155

Hannover Medical School12,100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

12,100

Conditions

Lung Cancer

Interventions

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

Eligibility

Sex: ALLMin age: 55 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

LungenClinic Grosshansdorf

Großhansdorf, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Outcomes

Primary Outcomes

Primary endpoint

Positive predictive value (PPV) for lung cancer detection with different inclusion methods (NELSON vs. PLCO) after 2 screening rounds.

Time frame: 5 years

Secondary Outcomes

Key secondary endpoint 1

Proportion of individuals selected for screening within the high-risk population.

Time frame: 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.

Time frame: 5 years

Key secondary endpoint 3

Proportion of lung cancers detected with in the high-risk population after 5 years.

Time frame: 5 years

Key secondary endpoint 4

Specificity within the overall population after 5-year follow-up.

Time frame: 5 years

Key secondary endpoint 5

Sensitivity within the overall population after 5-year follow-up.

Time frame: 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.

Time frame: 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".

Data from ClinicalTrials.gov

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