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CC BY-NC-ND 4.0 · Rofo 2022; 194(12): 1333-1345
DOI: 10.1055/a-1853-8291
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Design and Rationale of the HANSE Study: A Holistic German Lung Cancer Screening Trial Using Low-Dose Computed Tomography

Design und Rationale der HANSE-Studie: Eine ganzheitliche deutsche Lungenkrebs-Früherkennungs-Studie unter Verwendung von Niedrigdosis-Computertomografie
Jens Vogel-Claussen 
1   Department of Diagnostic and Interventional Radiology, Hannover Medical School, Hannover, Germany
2   Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research, Giessen, Germany
,
Florian Lasch
3   Department of Biostatistics, Hannover Medical School, Hannover, Germany
,
Benjamin-Alexander Bollmann
4   Department of respiratory medicine, Hannover Medical School, Hannover, Germany
2   Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research, Giessen, Germany
,
Katharina May
5   Department of Radiology and Nuclear Medicine, University Medical Center Schleswig-Holstein Campus Lübeck, Lübeck, Germany
,
Alexander Kuhlmann
6   Working Group Health Economics, Martin Luther University Halle Wittenberg, Halle, Germany
2   Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research, Giessen, Germany
,
Gerald Schmid-Bindert
7   Oncology Medical Department, AstraZeneca GmbH, Hamburg, Germany
8   Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany
,
Rudolf Kaaks
9   Translational Lung Research Center Heidelberg (TLRC-H), German Center for Lung Research, Giessen, Germany
10   Division of Cancer Epidemiology, German Cancer Research Center, Heidelberg, Germany
,
Jörg Barkhausen
5   Department of Radiology and Nuclear Medicine, University Medical Center Schleswig-Holstein Campus Lübeck, Lübeck, Germany
,
Sabine Bohnet
11   Department of Pulmonology, University Medical Center Schleswig Holstein Campus Lübeck, Lübeck, Germany
12   Airway Research Center North (ARCN), German Center for Lung Research, Giessen, Germany
,
Martin Reck
13   Department of Thoracic Oncology, LungenClinic Grosshansdorf GmbH, Grosshansdorf, Germany
12   Airway Research Center North (ARCN), German Center for Lung Research, Giessen, Germany
› Author AffiliationsThe HANSE study is funded by AstraZeneca GmbH (Wedel, Germany) and the German Center for Lung Research (DZL).
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Abstract

Background

Despite the high prevalence and mortality of lung cancer and proven effectiveness of low-dose computed tomography (LDCT) to reduce mortality, Germany still lacks a national screening program. The German Institute for Quality and Efficiency in Health Care (IQWiG) and the Federal Office for Radiation Protection (BfS) both published positive scientific evaluations recommending a quality-controlled national screening program. IQWiG underlined the importance of a clear risk definition, integrated smoking cessation programs, and quality assurance, highlighting the necessity of procedural optimization.

Methods and Objectives

In the HANSE study, former and current smokers aged 55–79 years are assessed for their lung cancer risk by the NELSON and PLCOM2012 risk scores. 5000 high-risk participants, defined as PLCOM2012 6-year risk ≥ 1.58 % or fulfilling NELSON risk inclusion criteria, will be screened by LDCT at baseline and after 12 months. Lung nodules are analyzed by a modified Lung-RADS 1.1 score of the HANSE study, and values of emphysema and coronary calcium are determined and randomly reported to the participants. 7100 low-risk participants serve as a control. All patients are followed-up for up to 10 years. The sensitivity and specificity of the two risk assessments and LDCT screening, effects of the randomized LDCT reporting, efficiency of lung nodule management, and several other factors are assessed to analyze the success and quality of the holistic screening program.

Conclusion

The HANSE study is designed as a holistic lung cancer screening study in northern Germany to answer pressing questions for a successful implementation of an effective German lung cancer screening program.

Key Points:

  • HANSE is designed to address pressing questions for the implementation of lung cancer screening in Germany.

  • HANSE compares NELSON and PLCOM2012 risk assessments for optimal definition of the high-risk group. 

  • HANSE integrates cardiac calcium and pulmonary emphysema scoring in a holistic screening approach.

Citation Format

  • Vogel-Claussen J, Lasch F, Bollmann B et al. Design and Rationale of the HANSE Study: A Holistic German Lung Cancer Screening Trial Using Low-Dose Computed Tomography. Fortschr Röntgenstr 2022; 194: 1333 – 1345

Zusammenfassung

Hintergrund

Trotz der hohen Prävalenz und Mortalität von Lungenkrebs und der nachgewiesenen Wirksamkeit von Niedrigdosis-Computertomografie (LDCT) zur Senkung der Mortalitätsrate existiert in Deutschland noch kein nationales Früherkennungsprogramm. Das Deutsche Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) wie auch das Bundesamt für Strahlenschutz (BfS) haben positive wissenschaftliche Bewertungen mit Empfehlungen für ein qualitätskontrolliertes nationales Früherkennungsprogramm veröffentlicht. Das IQWiG betonte die Notwendigkeit klar definierter Risikokriterien, der Integration eines Rauchstoppprogramms sowie der Sicherstellung hoher Qualitätsstandards, was die Bedeutung von Prozessoptimierungen unterstreicht.

Methoden & Ziele

In der HANSE-Studie werden ehemalige und aktive Raucher im Alter von 55–79 Jahren bezüglich ihres Lungenkrebsrisikos anhand der NELSON und PLCOM2012-Kriterien untersucht. 5000 Probanden mit hohem Risiko, definiert als PLCOM2012 6-Jahres-Risiko ≥ 1,58 % oder Erfüllen der NELSON-Kriterien, werden mittels LDCT zur Baseline sowie nach 12 Monaten untersucht. Lungenknötchen werden anhand eines modifizierten Lung-RADS 1.1 Scores der HANSE-Studie analysiert und zusätzlich Werte eines möglichen Lungenemphysems und koronaren Kalziums bestimmt und dem Befundbericht an die Probanden randomisiert beigefügt. 7100 Probanden mit niedrigem Risiko dienen als Kontrollgruppe. Alle Probanden werden für bis zu 10 Jahre nachverfolgt. Die Sensitivität und Spezifität der Risiko-Kriterien und der LDCT-Untersuchung, die Effekte der randomisierten LDCT-Befundbriefinhalte, die Effizienz des Knoten-Managements sowie weitere Parameter werden untersucht, um den Erfolg und die Qualität dieses holistischen Früherkennungsprogramms zu überprüfen.

Schlussfolgerung

Die HANSE-Studie ist als holistische Lungenkrebs-Screening-Studie in Norddeutschland konzipiert und dient der Beantwortung drängender Fragen für eine erfolgreiche Implementierung eines Lungenkrebsfrüherkennungsprogramms in Deutschland.

Kernaussagen

  • Die HANSE-Studie ist als Vorreiter eines Früherkennungsprogramms für Lungenkrebs in Deutschland konzipiert.

  • HANSE vergleicht die NELSON-Risikobewertung und den PLCOM2012-Score zur besseren Definition der Hochrisikogruppe.

  • HANSE integriert koronares Kalzium-Scoring und den Lungenemphysem-Score in ein ganzheitliches Screening-Programm.

Key words

screening - lung cancer - low-dose CT

Supplement



Publication History

Received: 04 February 2022

Accepted: 29 April 2022

Article published online:
02 August 2022

© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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