Screening for lung cancer by chest radiography
| ISRCTN | ISRCTN90639073 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90639073 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/12/2011
- Registration date
- 21/12/2011
- Last edited
- 22/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Using chest x-rays to screen for lung cancer was suggested in the 1990s by four Japanese studies to reduce death rates (mortality). However, the results of have yet to be confirmed in western countries, and none of several other studies showed a mortality reduction after chest x-ray screening. Studies performed in the 1970s failed to answer the question of the effectiveness of x-ray screening; however, the possibility was recognized that a small but important benefit from annual x-rays could have been missed. The effectiveness of screening for lung cancer on a population level therefore remains controversial. The aim of this study is to assess whether x-ray screening decreases lung cancer mortality at a population level.
Who can participate?
Current smokers or ex-smokers, aged 45 to 75
What does the study involve?
Screening consists of a chest x-ray at the start of the study and annual repeat chest x-rays for 4 years, with usual care follow-up. The lung cancer death rates are compared with the results from a group who receive usual care without screening.
What are the possible benefits and risks in participating?
The possible benefits include an increased chance of surviving lung cancer. The possible risks include false-positive test results, futile diagnosis of a benign (non-cancer) lesion, complicated invasive diagnosis of a benign lesion, and anxiety from the detection of an indeterminate lesion.
Where is the study run from?
University of Insubria (Italy)
When is the study starting and how long is it expected to run for?
July 1997 to December 2017.
Who is funding the study?
University of Insubria (Italy)
Who is the main contact?
Prof. Lorenzo Dominioni
lorenzo.dominioni@uninsubria.it
Contact information
Scientific
University of Insubria
Department of Surgical and Morphological Sciences
Via Guicciardini 9
Varese
21100
Italy
| Phone | +39 (0)332 278 680 |
|---|---|
| lorenzo.dominioni@uninsubria.it |
Study information
| Study design | Non-randomized screening comparison cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Screening for lung cancer by chest radiography: a non-randomised cohort study |
| Study objectives | 1. To ascertain whether chest radiography screening in smokers and ex-smokers at community level decreases lung cancer specific mortality 2. To evaluate the lung cancer detection results and the long-term survival in radiographic screening participants as well as in non-participants of the screening invited population based cohort 3. To estimate cost-effectiveness of radiographic screening for lung cancer and to help policy decision making |
| Ethics approval(s) | Varese Hospital and Health District Ethics Committee, 20/05/1997 |
| Health condition(s) or problem(s) studied | Lung cancer |
| Intervention | 1. Baseline CXR screening and annual repeat screen for 4 years, in addition to usual care 2. Smoking cessation advice |
| Intervention type | Other |
| Primary outcome measure | Lung cancer specific mortality (reduction) |
| Secondary outcome measures | 1. Lung cancer detection results: 1.1. Lung cancer stage distribution 1.2. Histological subtype distribution 1.3. Resectability 2. Overall survival and lung-cancer specific survival 3. Cost-effectiveness |
| Overall study start date | 01/07/1997 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 7000 |
| Key inclusion criteria | 1. Subjects of both genders 2. 45-75 years of age 3. Cigarette smoking history of >10 pack-years (current smoker or ex-smoker for less than 10 years) 4. Resident in Italy 5. Do not have symptoms of lung cancer: 5.1. Bloody or worsening cough 5.2. Hoarseness 5.3. Unexplained weight loss 6. Not diagnosed with or suspected of having lung cancer |
| Key exclusion criteria | 1. Moderate or poor health 2. Unfit for possible thoracotomy |
| Date of first enrolment | 01/07/1997 |
| Date of final enrolment | 01/12/2013 |
Locations
Countries of recruitment
- Italy
Study participating centre
21100
Italy
Sponsor information
University/education
Department of Surgical and Morphological Sciences
Via Guicciardini 9
Varese
21100
Italy
| Phone | +39 (0)332 393 606 |
|---|---|
| segreteria.dscm@uninsubria.it | |
| Website | http://www.uninsubria.it/uninsubria/home.html |
"ROR" |
https://ror.org/00s409261 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University of Insubria
- Location
- Italy
No information available
No information available
No information available
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 | preliminary results | 01/12/2000 | Yes | No | |
| Other publications | self-selection effects | 01/04/2010 | Yes | No |
Editorial Notes
22/06/2017: Plain English summary added.
