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Italian Lung Cancer Screening Trial (ITALUNG)

NCT02777996 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3106

Last updated 2016-05-20

No results posted yet for this study

Summary

ITALUNG is a RCT for the evaluation of the efficacy of lung cancer screening with low-dose Computer Tomography (LDCT) , carried out in three screening centers in Florence, Pisa and Pistoia districts of the Tuscany region of Italy.

3106 high risk subjects (age 55-69, smokers or ex-smokers) were recruited and randomized to the Active arm (Baseline + 3 annually repeated LDCT screening) or to the Passive arm, followed up in usual care (no screening reccomended ) All subjects were invited, if smokers, to consider smoking cessation practice. Follow-up for cause specific mortality and overall mortality and for lung cancer incidence was performed (actually at 9.3 years since randomization) . Blood and sputum samples were stored from the Active arm in a Biobank, with 1304 subjects enrolled in the Italung Biomarker study.

Conditions

Interventions

DEVICE

Low Dose Computed Tomography

Assessment protocol were adopted from the ELCAP study (modified) for Non Calcific Nodule with a diameter of less- equal than 5 mm at baseline and 3mm at repeated.

Sponsors & Collaborators

  • University of Florence

    collaborator OTHER

  • University of Pisa

    collaborator OTHER

  • Local Health Authority Pistoia (ITALY)

    collaborator UNKNOWN

  • Careggi Hospital

    collaborator OTHER

  • Cancer Prevention and Research Institute, Italy

    lead OTHER

Principal Investigators

  • Francesca M Carozzi, MSC · Cancer Laboratory Deputy Director

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02777996 on ClinicalTrials.gov