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 of protocol
Not provided at time of registration
Contact information
Mr Simon Roether
Scientific
Scientific
German cancer research center
Division of Cancer Epidemiology
INF 280
Heidelberg
69120
Germany
| Phone | +49 (0)6221 422389 |
|---|---|
| s.roether@dkfz-heidelberg.de |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| 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 | Mortality from lung cancer at 5 and 10 years. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/08/2007 |
| Completion date | 01/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
German cancer research center
Heidelberg
69120
Germany
69120
Germany
Sponsor information
German Cancer Research Centre (Deutsches Krebsforschungszentrum)
Research organisation
Research organisation
c/o Prof Otmar Wiestler
German Cancer Research Centre
Division of Cancer Epidemiology
INF 280
Heidelberg
69120
Germany
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
