Condition category
Cancer
Date applied
12/12/2011
Date assigned
21/12/2011
Last edited
22/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lorenzo Dominioni

ORCID ID

Contact details

University of Insubria
Department of Surgical and Morphological Sciences
Via Guicciardini 9
Varese
21100
Italy
+39 (0)332 278 680
lorenzo.dominioni@uninsubria.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Screening for lung cancer by chest radiography: a non-randomised cohort study

Acronym

Study hypothesis

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

Varese Hospital and Health District Ethics Committee, 20/05/1997

Study design

Non-randomized screening comparison cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/07/1997

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

7000

Participant exclusion criteria

1. Moderate or poor health
2. Unfit for possible thoracotomy

Recruitment start date

01/07/1997

Recruitment end date

01/12/2013

Locations

Countries of recruitment

Italy

Trial participating centre

University of Insubria
Varese
21100
Italy

Sponsor information

Organisation

University of Insubria (Italy)

Sponsor details

Department of Surgical and Morphological Sciences
Via Guicciardini 9
Varese
21100
Italy
+39 (0)332 393 606
segreteria.dscm@uninsubria.it

Sponsor type

University/education

Website

http://www.uninsubria.it/uninsubria/home.html

Funders

Funder type

University/education

Funder name

Università degli Studi dell'Insubria

Alternative name(s)

University of Insubria

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Italy

Funder name

Associazione PREDICA Onlus (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Lions Clubs District 108 Ib-1 annual grants (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Associazione AMARE, Como (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Associazione P. Giancola per la Ricerca sul Cancro, Como (Italy)

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

2000 preliminary results in: http://www.ncbi.nlm.nih.gov/pubmed/11147609
2010 self-selection effects in: http://www.ncbi.nlm.nih.gov/pubmed/20142770

Publication citations

  1. Dominioni L, Imperatori A, Rovera F, Ochetti A, Paolucci M, Dionigi G, Lung cancer screening in cigarette smokers in the province of Varese, Italy., Cancer, 2000, 89, 11 Suppl, 2345-2348.

  2. Dominioni L, Rotolo N, Poli A, Paolucci M, Sessa F, D'Ambrosio V, Paddeu A, Mantovani W, Imperatori A, Self-selection effects in smokers attending lung cancer screening: a 9.5-year population-based cohort study in Varese, Italy., J Thorac Oncol, 2010, 5, 4, 428-435, doi: 10.1097/JTO.0b013e3181d2efc7.

Additional files

Editorial Notes

22/06/2017: Plain English summary added.