Condition category
Cancer
Date applied
29/05/2007
Date assigned
19/07/2007
Last edited
19/07/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

German Cancer Research Centre (Deutsches Krebsforschungszentrum)

Sponsor details

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

Sponsor type

Research organisation

Website

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

Publication citations

Additional files

Editorial Notes