Spiral computed tomography scanning for the early detection of lung cancer

ISRCTN	ISRCTN30604390
DOI	https://doi.org/10.1186/ISRCTN30604390
Protocol serial number	N/A
Sponsor	German Cancer Research Centre (Deutsches Krebsforschungszentrum)
Funders	German Research Foundation (ref: BE2486/2-1), Dietmar Hopp Foundation (Dietmar-Hopp-Stiftung) (ref: DL-26.1.07) (Germany)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Simon Roether
Scientific

German cancer research center
Division of Cancer Epidemiology
INF 280
Heidelberg
69120
Germany

Phone	+49 (0)6221 422389
Email	s.roether@dkfz-heidelberg.de

Primary study design	Interventional
Study design	Randomized controlled trial with an MSCT screening arm and an usual care control arm.
Secondary study design	Randomised controlled trial
Scientific title	Spiral computed tomography scanning for the early detection of lung cancer
Study acronym	LUSI
Study objectives	Lung cancer sreening with Multislice Spiral Computed Tomography (MSCT) reduces the mortality from lung cancer by at least 20%.
Ethics approval(s)	Local Ethics Committee: Alte Glockengiesserei 11/1, 69115 Heidelberg (Germany), approved on 7 March 2007 (ref: 073/2001)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Mortality from lung cancer at 5 and 10 years.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/02/2012

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	4000
Total final enrolment	4052
Key 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
Key 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
Date of first enrolment	01/08/2007
Date of final enrolment	01/02/2012

German cancer research center

Heidelberg
69120
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/03/2021	27/07/2021	Yes	No

27/07/2021: Publication reference and total final enrolment added.