Active — Not RecruitingNot Applicable

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

Germany12,100 participantsStarted 2021-05-20

Plain-language 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.

Who can participate

Age range55 Years – 79 Years

SexALL

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Inclusion criteria

✓. Male and female subjects aged 55-79 years
✓. Current or former smokers
✓. 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).
✓. 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

✕. Comorbidity, which would unequivocally contraindicate either screening or treatment if lung cancer is detected.
✕. History of chest CT within the past year preceding the invitation.
✕. Inability to undergo non-contrast CT (e.g. ≥ 200 kg body weight, inability to lie flat).
✕. Pregnancy
✕. Risk of non-compliance with study procedures.

What they're measuring

Primary endpoint

Timeframe: 5 years

Trial details

NCT IDNCT04913155

SponsorHannover Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-01

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