NCT04913155

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,100

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
21mo left

Started May 2021

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
May 2021Jan 2028

First Submitted

Initial submission to the registry

May 10, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

October 3, 2025

Status Verified

July 1, 2025

Enrollment Period

2.8 years

First QC Date

May 10, 2021

Last Update Submit

September 29, 2025

Conditions

Lung Cancer

Keywords

Lung cancerScreening programLow-dose CT

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint

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

    5 years

Secondary Outcomes (20)

  • Key secondary endpoint 1

    1 year

  • Key secondary endpoint 2

    5 years

  • Key secondary endpoint 3

    5 years

  • Key secondary endpoint 4

    5 years

  • Key secondary endpoint 5

    5 years

  • +15 more secondary outcomes

Study Arms (5)

Reporting group (coronary calcium score and emphysema score)

OTHER

Coronary calcium score and emphysema score are reported to subjects

Radiation: Low-dose CT screening

Reporting group (coronary calcium score only)

OTHER

Only coronary calcium score is reported to subjects

Radiation: Low-dose CT screening

Reporting group (emphysema score only)

OTHER

Only emphysema score is reported to subjects

Radiation: Low-dose CT screening

Non-reporting group

OTHER

Coronary calcium score and emphysema score are not reported to subjects

Radiation: Low-dose CT screening

Low-risk group

NO INTERVENTION

No CT screening, collection of health data only

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

Non-reporting groupReporting group (coronary calcium score and emphysema score)Reporting group (coronary calcium score only)Reporting group (emphysema score only)

Eligibility Criteria

Age55 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects aged 55-79 years
  • Current or former smokers

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

LungenClinic Grosshansdorf

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Related Publications (1)

  • Vogel-Claussen J, Bollmann BA, May K, Stiebeler S, Dettmer S, Faron A, Kuhlmann A, Schmid-Bindert G, Kaaks R, Barkhausen J, Bohnet S, Reck M; HANSE investigators. Effectiveness of NELSON versus PLCOm2012 lung cancer screening eligibility criteria in Germany (HANSE): a prospective cohort study. Lancet Oncol. 2025 Dec;26(12):1541-1551. doi: 10.1016/S1470-2045(25)00490-5. Epub 2025 Nov 10.

    PMID: 41232542DERIVED

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jens Vogel-Claussen, Prof. Dr.

    Hannover Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Randomized reporting of coronary calcium score and emphysema score
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Population-based Screening Study -Prospective, randomized comparator controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

June 4, 2021

Study Start

May 20, 2021

Primary Completion

March 1, 2024

Study Completion (Estimated)

January 1, 2028

Last Updated

October 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)