Contact information
Type
Scientific
Primary contact
Mr Simon Roether
ORCID ID
Contact details
German cancer research center
Division of Cancer Epidemiology
INF 280
Heidelberg
69120
Germany
+49 (0)6221 422389
s.roether@dkfz-heidelberg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LUSI
Study hypothesis
Lung cancer sreening with Multislice Spiral Computed Tomography (MSCT) reduces the mortality from lung cancer by at least 20%.
Ethics approval
Local Ethics Committee: Alte Glockengiesserei 11/1, 69115 Heidelberg (Germany), approved on 7 March 2007 (ref: 073/2001)
Study design
Randomized controlled trial with an MSCT screening arm and an usual care control arm.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Lung cancer
Intervention
Intervention arm:
1. MSCT-scanning for the early detection of lung cancer immediately at time of randomisation and 4 times annually
2. Further assessment of suspicious nodules according to an internationally agreed algorithm
3. Counselling aimed at smoking cessation at time of randomisation
Control arm: Counselling aimed at smoking cessation at time of randomisation.
Both arms will receive annual follow-up by mailed questionnaires for assessment of Disease outcome for further 5 years after the 5 screening rounds of the intervention group. At time of randomization 20 ml blood sample will be taken in both intervention and control arms for concomitant biomarker research.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Mortality from lung cancer at 5 and 10 years.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/08/2007
Overall trial end date
01/02/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 50-69
2. Smoking history of at least 40 pack-years
3. If under the age of 60, current smokers or ceased smoking within the last five years
4. Able to complete a self-administered epidemiology questionnaire providing details on smoking history, family history of lung and other cancers (if any), occupational history and previous illnesses
5. Agree to be randomised to screening with annual low dose spiral CT plus smoking cessation counseling or only smoking cessation counseling
6. Have signed an informed consent form
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
4000
Participant exclusion criteria
1. History of lung cancer or other malignancy (except basal cell carcinoma)
2. History of a disease that would preclude surgical as well as medical treatment of lung cancer
3. Other serious illness that would reduce life expectancy to less than 10 years
Recruitment start date
01/08/2007
Recruitment end date
01/02/2012
Locations
Countries of recruitment
Germany
Trial participating centre
German cancer research center
Heidelberg
69120
Germany
Funders
Funder type
Not defined
Funder name
German Research Foundation (ref: BE2486/2-1)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dietmar Hopp Foundation (Dietmar-Hopp-Stiftung) (ref: DL-26.1.07) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary