Massive lung screening trial aims to catch cancer early
NCT ID NCT04913155
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a lung cancer screening program can work effectively in Germany. Over 12,000 current or former smokers aged 55-79 will be screened using two different risk-based methods to see which finds more cancers early. The goal is to integrate screening into existing healthcare systems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12,100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2021
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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LungenClinic Grosshansdorf
Großhansdorf, Schleswig-Holstein, 22927, Germany
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Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
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Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538, Germany
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