Screening for lung cancer by chest radiography

ISRCTN	ISRCTN90639073
DOI	https://doi.org/10.1186/ISRCTN90639073
Protocol serial number	N/A
Sponsor	University of Insubria (Italy)
Funders	Università degli Studi dell'Insubria, Associazione PREDICA Onlus (Italy), Lions Clubs District 108 Ib-1 annual grants (Italy), Associazione AMARE, Como (Italy), Associazione P. Giancola per la Ricerca sul Cancro, Como (Italy)

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Lorenzo Dominioni
Scientific

University of Insubria
Department of Surgical and Morphological Sciences
Via Guicciardini 9
Varese
21100
Italy

Phone	+39 (0)332 278 680
Email	lorenzo.dominioni@uninsubria.it

Study information

Primary study design	Observational
Study design	Non-randomized screening comparison cohort study
Secondary study design	Cohort study
Study type	Participant 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(s)	Lung cancer specific mortality (reduction)
Key secondary outcome measure(s)	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
Completion date	31/12/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

University of Insubria

Varese
21100
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/06/2017: Plain English summary added.