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Italian Lung Cancer Screening Trial (ITALUNG) (ITALUNG)

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ClinicalTrials.gov Identifier: NCT02777996
Recruitment Status : Completed
First Posted : May 19, 2016
Last Update Posted : May 20, 2016
Sponsor:
Collaborators:
University of Florence
University of Pisa
Local Health Authority Pistoia (ITALY)
Careggi Hospital
Information provided by (Responsible Party):
Francesca Carozzi, Cancer Prevention and Research Institute, Italy

Brief 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.


Condition or disease Intervention/treatment Phase
Lung Cancer Device: Low Dose Computed Tomography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: An Italian Randomized Trial for the Evaluation of the Efficacy of Lung Cancer Screening With Low Dose Computed Tomography. The ITALUNG Study.
Study Start Date : September 2003
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Arm Intervention/treatment
Active Comparator: Screening arm
Low Dose Computed Tomography offered at baseline and for 3 repeated rounds
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.

No Intervention: Passive Arm
Eligible subjects were randomized to follow up in usual care (in Europe lung cancer screening is not raccomended), according with the GP.



Primary Outcome Measures :
  1. lung cancer specific mortality [ Time Frame: till 8 years or more of average follow up since randomization ]
    All subjects were followed up using the Tuscany Region Registry of causes of death


Secondary Outcome Measures :
  1. overall mortality [ Time Frame: till 8 years or more of average follow up since randomization ]
    All subjects were followed up using the Tuscany Region Registry of causes of death

  2. Incidence excess/overdiagnosis [ Time Frame: till 8 years or more of average follow up from randomization ]
    All subjects were followed up using the Tuscany Region Registry of Cancer



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Ages Eligible for Study:   55 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resident in the catchment area, in the list of GP's
  • Current smoker
  • Ex-smoker (<8years)

Exclusion Criteria:

  • Non smoker
  • Ex-smoker (=>8years)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777996


Locations
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Italy
Cancer Prevention and Research Institute, ISPO
Firenze, FI, Italy, 50139
Sponsors and Collaborators
Cancer Prevention and Research Institute, Italy
University of Florence
University of Pisa
Local Health Authority Pistoia (ITALY)
Careggi Hospital
Investigators
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Principal Investigator: Francesca M Carozzi, MSC Cancer Laboratory Deputy Director
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
In Italian, available under request

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francesca Carozzi, Deputy Director Cancer Laboratory Unit, Cancer Prevention and Research Institute, Italy
ClinicalTrials.gov Identifier: NCT02777996    
Other Study ID Numbers: 23/2003/CEL
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: European Collaboration of Randomized Controlled Trial (RCT) in lung cancer screening
Keywords provided by Francesca Carozzi, Cancer Prevention and Research Institute, Italy:
screening
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases