Italian Lung Cancer Screening Trial (ITALUNG)

NCT02777996 | Completed

• 1 other identifier: 23/2003/CEL
• Study Type: interventional
• Target: 3,106
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

screening

Outcome Measures

Primary Outcomes (1)

• lung cancer specific mortality

  All subjects were followed up using the Tuscany Region Registry of causes of death

  till 8 years or more of average follow up since randomization

Secondary Outcomes (2)

• overall mortality

  till 8 years or more of average follow up since randomization

• Incidence excess/overdiagnosis

  till 8 years or more of average follow up from randomization

Study Arms (2)

Screening arm

ACTIVE COMPARATOR

Low Dose Computed Tomography offered at baseline and for 3 repeated rounds

Device: Low Dose Computed Tomography

Passive Arm

NO INTERVENTION

Eligible subjects were randomized to follow up in usual care (in Europe lung cancer screening is not raccomended), according with the GP.

Interventions

Low Dose Computed Tomography DEVICE

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.

Screening arm

Eligibility Criteria

• Age: 55 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Non smoker
• Ex-smoker (=\>8years)

Sponsors & Collaborators

• Cancer Prevention and Research Institute, Italy: lead
• University of Florence: collaborator
• University of Pisa: collaborator
• Local Health Authority Pistoia (ITALY): collaborator
• Careggi Hospital: collaborator

Study Sites (1)

Cancer Prevention and Research Institute, ISPO

Florence, FI, 50139, Italy

Location

Related Publications (4)

• Lopes 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 RESULT

• Lopes 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 RESULT

• Puliti 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 DERIVED

• Paci 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 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Francesca M Carozzi, MSC

  Cancer Laboratory Deputy Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director Cancer Laboratory Unit

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: September 1, 2003
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 20, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)