Spiral computed tomography scanning for the early detection of lung cancer

ISRCTN ISRCTN30604390
DOI https://doi.org/10.1186/ISRCTN30604390
Secondary identifying numbers N/A
Submission date
29/05/2007
Registration date
19/07/2007
Last edited
27/07/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

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

Study information

Study designRandomized controlled trial with an MSCT screening arm and an usual care control arm.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Scientific titleSpiral computed tomography scanning for the early detection of lung cancer
Study acronymLUSI
Study hypothesisLung 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)
ConditionLung cancer
InterventionIntervention 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 typeOther
Primary outcome measureMortality from lung cancer at 5 and 10 years.
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/08/2007
Overall study end date01/02/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants4000
Total final enrolment4052
Participant inclusion criteria1. 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 exclusion criteria1. 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 date01/08/2007
Recruitment end date01/02/2012

Locations

Countries of recruitment

  • Germany

Study participating centre

German cancer research center
Heidelberg
69120
Germany

Sponsor information

German Cancer Research Centre (Deutsches Krebsforschungszentrum)
Research organisation

c/o Prof Otmar Wiestler
German Cancer Research Centre
Division of Cancer Epidemiology
INF 280
Heidelberg
69120
Germany

ROR logo "ROR" https://ror.org/04cdgtt98

Funders

Funder type

Not defined

German Research Foundation (ref: BE2486/2-1)

No information available

Dietmar Hopp Foundation (Dietmar-Hopp-Stiftung) (ref: DL-26.1.07) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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