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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
- 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
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
|Cancer Prevention and Research Institute, ISPO|
|Firenze, FI, Italy, 50139|
|Principal Investigator:||Francesca M Carozzi, MSC||Cancer Laboratory Deputy Director|