Holistic lung cancer screening program in Northern Germany
HANSE - Holistic Implementation Study Assessing a Northern German Interdisciplinary Lung Cancer Screening Effort, Population-based Screening Study -Prospective, Randomized Comparator Controlled
This study is testing a new lung cancer screening program using low-dose CT scans for high-risk individuals in Northern Germany, while also offering support to quit smoking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12100 (estimated) |
| Ages | 55 Years to 79 Years |
| Sex | All |
| Sponsor | Hannover Medical School Academic / other |
| Locations | 3 sites (Hannover, Niedersachsen and 2 other locations) |
| Trial ID | NCT04913155 on ClinicalTrials.gov |
What this trial studies
The HANSE study aims to implement a comprehensive lung cancer screening program using low-dose CT scans in Northern Germany. It focuses on identifying high-risk individuals based on specific criteria and integrating smoking cessation support. The study will assess the feasibility of this program within existing certified lung cancer centers and evaluate the effectiveness of risk forecasting models. Additionally, it will gather long-term outcome data from participants who do not meet the high-risk criteria.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 55-79 who are current or former smokers with a calculated risk score indicating a high likelihood of developing lung cancer.
Not a fit: Patients who do not meet the high-risk criteria for lung cancer screening may not receive direct benefits from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve early detection of lung cancer, leading to better patient outcomes.
How similar studies have performed: Other studies have shown success with lung cancer screening programs using low-dose CT, indicating a promising approach for early detection.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hannover, Niedersachsen and 2 other locations
- Medizinische Hochschule Hannover — Hannover, Niedersachsen, Germany (Recruiting)
- LungenClinic Grosshansdorf — Großhansdorf, Schleswig-Holstein, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein — Lübeck, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Study coordinator: Jens Vogel-Claussen, Prof. Dr.
- Email: Vogel-Claussen.Jens@mh-hannover.de
- Phone: +49 511 532 9817
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.