NCT01248806

Brief Summary

The purpose of this study is to offer annual low-dose spiral CT radiological examination for 5 years to 5000 volunteers from the general population who are considered to be at high risk of developing lung cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2010

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 13, 2022

Status Verified

May 1, 2022

Enrollment Period

12.3 years

First QC Date

November 24, 2010

Last Update Submit

May 12, 2022

Conditions

Subjects at High Risk of Lung Cancer Due to Smoking

Keywords

Lung noduleScreeningSpiral low - dose computed tomographyLung cancer

Outcome Measures

Primary Outcomes (2)

  • To determine the prevalence of malignant pulmonary disease at the first CT examination

    CT scan

    once after enrollment

  • To assess the radiological detection of disease during the 10 year follow-up

    CT scan

    once per year for a 10 year follow-up period

Secondary Outcomes (1)

  • To determine the overall resectability of detected malignant tumours

    once after detection of malignancy

Study Arms (1)

Smokers or former smokers, Aged ≥ 50

Men and women current daily smokers or former smokers, Aged ≥ 50

Radiation: Low dose CT scan

Interventions

Low dose CT scanRADIATION

A low dose CT scan of the lungs is performed after the inclusion of the patient in the study and if negative for active disease, a CT scan if performed once per year for whole period of follow-up

Also known as: High resoluzione CT scan
Smokers or former smokers, Aged ≥ 50

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • Age ≥ 50
  • Current daily smokers or former smokers (total dose ≥ 20 pack/year, calculated by multiplying the number of packs per day by the total number of years smoked)

You may not qualify if:

  • Not currently suffering from malignant disease or having had malignant disease within the last 5 years
  • Not having known pulmonary pathology
  • Not having performed a chest CT scan during the last 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, Italy

Location

Related Publications (3)

  • Veronesi G, Bellomi M, Mulshine JL, Pelosi G, Scanagatta P, Paganelli G, Maisonneuve P, Preda L, Leo F, Bertolotti R, Solli P, Spaggiari L. Lung cancer screening with low-dose computed tomography: a non-invasive diagnostic protocol for baseline lung nodules. Lung Cancer. 2008 Sep;61(3):340-9. doi: 10.1016/j.lungcan.2008.01.001. Epub 2008 Mar 4.

    PMID: 18308420RESULT

  • Pelosi G, Sonzogni A, Veronesi G, De Camilli E, Maisonneuve P, Spaggiari L, Manzotti M, Masullo M, Taliento G, Fumagalli C, Bellomi M, Travis WD, Kadivar M, Viale G. Pathologic and molecular features of screening low-dose computed tomography (LDCT)-detected lung cancer: a baseline and 2-year repeat study. Lung Cancer. 2008 Nov;62(2):202-14. doi: 10.1016/j.lungcan.2008.03.012. Epub 2008 May 2.

    PMID: 18450320RESULT

  • Veronesi G, Bellomi M, Veronesi U, Paganelli G, Maisonneuve P, Scanagatta P, Leo F, Pelosi G, Travaini L, Rampinelli C, Trifiro G, Sonzogni A, Spaggiari L. Role of positron emission tomography scanning in the management of lung nodules detected at baseline computed tomography screening. Ann Thorac Surg. 2007 Sep;84(3):959-65; discussion 965-6. doi: 10.1016/j.athoracsur.2007.04.058.

    PMID: 17720408RESULT

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Massimo Bellomi, PhD

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 25, 2010

Study Start

October 1, 2004

Primary Completion

January 1, 2017

Study Completion

December 1, 2021

Last Updated

May 13, 2022

Record last verified: 2022-05

Locations

IT(1)