Clinical trial · Interventional
Italian Lung Cancer Screening Trial (ITALUNG)
An Italian Randomized Trial for the Evaluation of the Efficacy of Lung Cancer Screening With Low Dose Computed Tomography. The ITALUNG Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low Dose Computed Tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Screening arm
- description
- Low Dose Computed Tomography offered at baseline and for 3 repeated rounds
- interventionNames
- Device: Low Dose Computed Tomography
- type
- NO_INTERVENTION
- label
- Passive Arm
- description
- Eligible subjects were randomized to follow up in usual care (in Europe lung cancer screening is not raccomended), according with the GP.
Primary outcomes (1)
- measure
- lung cancer specific mortality
- timeFrame
- till 8 years or more of average follow up since randomization
- description
- All subjects were followed up using the Tuscany Region Registry of causes of death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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)
References
Publications (4)
- RESULTLopes Pegna A, Picozzi G, Mascalchi M, Maria Carozzi F, Carrozzi L, Comin C, Spinelli C, Falaschi F, Grazzini M, Innocenti F, Ronchi C, Paci E; ITALUNG Study Research Group. Design, recruitment and baseline results of the ITALUNG trial for lung cancer screening with low-dose CT. Lung Cancer. 2009 Apr;64(1):34-40. doi: 10.1016/j.lungcan.2008.07.003. Epub 2008 Aug 23. PMID 18723240
- RESULTLopes Pegna A, Picozzi G, Falaschi F, Carrozzi L, Falchini M, Carozzi FM, Pistelli F, Comin C, Deliperi A, Grazzini M, Innocenti F, Maddau C, Vella A, Vaggelli L, Paci E, Mascalchi M; ITALUNG Study Research Group. Four-year results of low-dose CT screening and nodule management in the ITALUNG trial. J Thorac Oncol. 2013 Jul;8(7):866-75. doi: 10.1097/JTO.0b013e31828f68d6. PMID 23612465
- DERIVEDPuliti D, Mascalchi M, Carozzi FM, Carrozzi L, Falaschi F, Paci E, Lopes Pegna A, Aquilini F, Barchielli A, Bartolucci M, Grazzini M, Picozzi G, Pistelli F, Rosselli A, Zappa M; ITALUNG Working Group. Decreased cardiovascular mortality in the ITALUNG lung cancer screening trial: Analysis of underlying factors. Lung Cancer. 2019 Dec;138:72-78. doi: 10.1016/j.lungcan.2019.10.006. Epub 2019 Oct 15. PMID 31654837
- DERIVEDPaci E, Puliti D, Lopes Pegna A, Carrozzi L, Picozzi G, Falaschi F, Pistelli F, Aquilini F, Ocello C, Zappa M, Carozzi FM, Mascalchi M; the ITALUNG Working Group. Mortality, survival and incidence rates in the ITALUNG randomised lung cancer screening trial. Thorax. 2017 Sep;72(9):825-831. doi: 10.1136/thoraxjnl-2016-209825. Epub 2017 Apr 4. PMID 28377492