Lung Cancer Prevention Screening Programme in Italy

NCT05766046 | Active Not Recruiting

• 1 other identifier: INT 292/20
• Study Type: interventional
• Target: 7,324
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized multicentered clinical study aims at implementing early diagnosis of lung cancer in high-risk heavy smokers in the Italian population. The main goal of the study is to develop a nationwide lung cancer prevention screening with high quality standard, similar to that of other screening programs i.e. breast, colon and cervix ongoing in Italy. The Italian Pulmonary Screening Network (RISP) includes 18 centers, which will promote primary prevention by offering a smoking cessation program (i.e. counselling and anti-smoking cytisine-based therapy) and secondary prevention by screening volunteers with chest Low Dose Computed Tomography (LDCT). The primary objective of the study is to demonstrate the non-inferiority of a risk-based screening strategy (less intensive, every 2 years) compared to the standard annual screening, in terms of stage I/II lung cancer incidence. Furthermore, the study aims to provide evidence whether blood biomarkers screening intervals can improve the efficiency of lung cancer screening by requiring less CT examinations while retaining the ability to diagnose lung cancer at curative state.

Conditions

Lung Cancer; Cardiovascular Diseases; COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection

Keywords

lung cancer; LDCT; cytisine; screening; smoking cessation; DOPC; cardiovascular diseases; primary prevention; secondary prevention; RCT; microRNA; biomarkers

Outcome Measures

Primary Outcomes (4)

• Change in lung cancer incidence

  Change in lung cancer incidence: evaluate the impact on lung cancer incidence through LDCT at annual or biennial intervals.

  3 years

• Change in lung cancer specific and overall mortality

  Change in lung cancer specific and overall mortality: evaluate the impact on lung cancer mortality through LDCT at annual or biennial intervals.

  5 years

• Change in smoking status

  Change in the percentage of smokers

  3 years

• Molecular risk profile through assessing the value of microRNA in blood and tissue samples

  MicroRNA expression profile, using TaqMan microfluidic cards: increased efficiency of lung cancer diagnosis by requiring less CT examinations while retaining the ability to diagnose lung cancer at curative state.

  5 years

Study Arms (2)

Standard arm

EXPERIMENTAL

Volunteers with a negative baseline LDCT will repeat LDCT after the first screening with an annual interval (according to guidelines)

Diagnostic Test: early lung cancer detection; Other: blood test

Risk-based arm

EXPERIMENTAL

Volunteers with a negative baseline LDCT will repeat LDCT after the first screening with an interval of two years.

Diagnostic Test: early lung cancer detection; Other: blood test

Interventions

early lung cancer detection DIAGNOSTIC_TEST

standard treatment for early lung cancer detection with LDCT at one or two years interval

Risk-based arm; Standard arm

blood test OTHER

blood analysis for microRNA and other biomarkers detection

Risk-based arm; Standard arm

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active smoker (≥ 30 packs/year)
• Former heavy smoker for ≤ 15 years (≥ 30 packs/year)
• Absence of tumors for at least 5 years
• Signature of informed consent for studio enrollment and processing of personal data

You may not qualify if:

• Severe chronic disease (e.g. severe respiratory and/or renal and/or hepatic and/or cardiac failure)
• Severe psychiatric problems
• Abuse of alcohol or other substances (including previous)

Sponsors & Collaborators

• Azienda Sanitaria Universitaria Integrata del Trentino: collaborator
• Ugo Pastorino: lead
• Presidio Ospedaliero Santo Spirito, Pescara: collaborator
• IRCCS Centro di Riferimento Oncologico di Basilicata, Potenza: collaborator
• Azienda Ospedaliera Pugliese Ciaccio: collaborator
• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale: collaborator
• Azienda Ospedaliera dei Colli: collaborator
• Azienda Ospedaliero-Universitaria di Parma: collaborator
• IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia, Reggio Emilia: collaborator
• Istituto Nazionale dei Tumori Regina Elena, Roma: collaborator
• Ospedale Policlinico San Martino: collaborator
• A.O. Ospedale Papa Giovanni XXIII: collaborator
• Azienda Ospedaliero, Universitaria Ospedali Riuniti: collaborator
• San Luigi Gonzaga Hospital: collaborator
• Istituto Tumori Giovanni Paolo II, BARI: collaborator
• Azienda Ospedaliera per l'Emergenza Canizzaro: collaborator
• Azienda Ospedaliero-Universitaria Careggi: collaborator
• Istituto Oncologico Veneto IRCCS: collaborator

Study Sites (1)

Chiara Bovolenta

Milan, MI, 20133, Italy

Location

Related Publications (18)

• Pastorino U, Ladisa V, Trussardo S, Sabia F, Rolli L, Valsecchi C, Ledda RE, Milanese G, Suatoni P, Boeri M, Sozzi G, Marchiano A, Munarini E, Boffi R, Gallus S, Apolone G. Cytisine Therapy Improved Smoking Cessation in the Randomized Screening and Multiple Intervention on Lung Epidemics Lung Cancer Screening Trial. J Thorac Oncol. 2022 Nov;17(11):1276-1286. doi: 10.1016/j.jtho.2022.07.007. Epub 2022 Jul 28.

  PMID: 35908731 BACKGROUND

• Milanese G, Sabia F, Ledda RE, Sestini S, Marchiano AV, Sverzellati N, Pastorino U. Volumetric Measurements in Lung Cancer Screening Reduces Unnecessary Low-Dose Computed Tomography Scans: Results from a Single-Center Prospective Trial on 4119 Subjects. Diagnostics (Basel). 2022 Jan 18;12(2):229. doi: 10.3390/diagnostics12020229.

  PMID: 35204320 BACKGROUND

• Pastorino U, Boeri M, Sestini S, Sabia F, Milanese G, Silva M, Suatoni P, Verri C, Cantarutti A, Sverzellati N, Corrao G, Marchiano A, Sozzi G. Baseline computed tomography screening and blood microRNA predict lung cancer risk and define adequate intervals in the BioMILD trial. Ann Oncol. 2022 Apr;33(4):395-405. doi: 10.1016/j.annonc.2022.01.008. Epub 2022 Jan 25.

  PMID: 35091076 BACKGROUND

• Silva M, Milanese G, Ledda RE, Nayak SM, Pastorino U, Sverzellati N. European lung cancer screening: valuable trial evidence for optimal practice implementation. Br J Radiol. 2022 May 1;95(1133):20200260. doi: 10.1259/bjr.20200260. Epub 2022 Jan 7.

  PMID: 34995141 BACKGROUND

• Rundo L, Ledda RE, di Noia C, Sala E, Mauri G, Milanese G, Sverzellati N, Apolone G, Gilardi MC, Messa MC, Castiglioni I, Pastorino U. A Low-Dose CT-Based Radiomic Model to Improve Characterization and Screening Recall Intervals of Indeterminate Prevalent Pulmonary Nodules. Diagnostics (Basel). 2021 Sep 3;11(9):1610. doi: 10.3390/diagnostics11091610.

  PMID: 34573951 BACKGROUND

• Tringali G, Milanese G, Ledda RE, Pastorino U, Sverzellati N, Silva M. Lung Cancer Screening: Evidence, Risks, and Opportunities for Implementation. Rofo. 2021 Oct;193(10):1153-1161. doi: 10.1055/a-1382-8648. Epub 2021 Mar 26.

  PMID: 33772489 BACKGROUND

• Silva M, Milanese G, Sestini S, Sabia F, Jacobs C, van Ginneken B, Prokop M, Schaefer-Prokop CM, Marchiano A, Sverzellati N, Pastorino U. Lung cancer screening by nodule volume in Lung-RADS v1.1: negative baseline CT yields potential for increased screening interval. Eur Radiol. 2021 Apr;31(4):1956-1968. doi: 10.1007/s00330-020-07275-w. Epub 2020 Sep 30.

  PMID: 32997182 BACKGROUND

• Pastorino U, Sverzellati N, Sestini S, Silva M, Sabia F, Boeri M, Cantarutti A, Sozzi G, Corrao G, Marchiano A. Ten-year results of the Multicentric Italian Lung Detection trial demonstrate the safety and efficacy of biennial lung cancer screening. Eur J Cancer. 2019 Sep;118:142-148. doi: 10.1016/j.ejca.2019.06.009. Epub 2019 Jul 20.

  PMID: 31336289 BACKGROUND

• Pastorino U, Silva M, Sestini S, Sabia F, Boeri M, Cantarutti A, Sverzellati N, Sozzi G, Corrao G, Marchiano A. Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy. Ann Oncol. 2019 Oct 1;30(10):1672. doi: 10.1093/annonc/mdz169. No abstract available.

  PMID: 31168572 BACKGROUND

• Pastorino U, Silva M, Sestini S, Sabia F, Boeri M, Cantarutti A, Sverzellati N, Sozzi G, Corrao G, Marchiano A. Prolonged lung cancer screening reduced 10-year mortality in the MILD trial: new confirmation of lung cancer screening efficacy. Ann Oncol. 2019 Jul 1;30(7):1162-1169. doi: 10.1093/annonc/mdz117.

  PMID: 30937431 BACKGROUND

• Gallus S, Lugo A, Suatoni P, Taverna F, Bertocchi E, Boffi R, Marchiano A, Morelli D, Pastorino U. Effect of Tobacco Smoking Cessation on C-Reactive Protein Levels in A Cohort of Low-Dose Computed Tomography Screening Participants. Sci Rep. 2018 Aug 27;8(1):12908. doi: 10.1038/s41598-018-29867-9.

  PMID: 30150729 BACKGROUND

• Silva M, Prokop M, Jacobs C, Capretti G, Sverzellati N, Ciompi F, van Ginneken B, Schaefer-Prokop CM, Galeone C, Marchiano A, Pastorino U. Long-Term Active Surveillance of Screening Detected Subsolid Nodules is a Safe Strategy to Reduce Overtreatment. J Thorac Oncol. 2018 Oct;13(10):1454-1463. doi: 10.1016/j.jtho.2018.06.013. Epub 2018 Jul 16.

  PMID: 30026071 BACKGROUND

• Sozzi G, Boeri M, Rossi M, Verri C, Suatoni P, Bravi F, Roz L, Conte D, Grassi M, Sverzellati N, Marchiano A, Negri E, La Vecchia C, Pastorino U. Clinical utility of a plasma-based miRNA signature classifier within computed tomography lung cancer screening: a correlative MILD trial study. J Clin Oncol. 2014 Mar 10;32(8):768-73. doi: 10.1200/JCO.2013.50.4357. Epub 2014 Jan 13.

  PMID: 24419137 BACKGROUND

• Pastorino U, Rossi M, Rosato V, Marchiano A, Sverzellati N, Morosi C, Fabbri A, Galeone C, Negri E, Sozzi G, Pelosi G, La Vecchia C. Annual or biennial CT screening versus observation in heavy smokers: 5-year results of the MILD trial. Eur J Cancer Prev. 2012 May;21(3):308-15. doi: 10.1097/CEJ.0b013e328351e1b6.

  PMID: 22465911 BACKGROUND

• National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.

  PMID: 21714641 BACKGROUND

• de Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, Lammers JJ, Weenink C, Yousaf-Khan U, Horeweg N, van 't Westeinde S, Prokop M, Mali WP, Mohamed Hoesein FAA, van Ooijen PMA, Aerts JGJV, den Bakker MA, Thunnissen E, Verschakelen J, Vliegenthart R, Walter JE, Ten Haaf K, Groen HJM, Oudkerk M. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial. N Engl J Med. 2020 Feb 6;382(6):503-513. doi: 10.1056/NEJMoa1911793. Epub 2020 Jan 29.

  PMID: 31995683 BACKGROUND

• Becker N, Motsch E, Trotter A, Heussel CP, Dienemann H, Schnabel PA, Kauczor HU, Maldonado SG, Miller AB, Kaaks R, Delorme S. Lung cancer mortality reduction by LDCT screening-Results from the randomized German LUSI trial. Int J Cancer. 2020 Mar 15;146(6):1503-1513. doi: 10.1002/ijc.32486. Epub 2019 Jun 20.

  PMID: 31162856 BACKGROUND

• Quaife SL, Ruparel M, Dickson JL, Beeken RJ, McEwen A, Baldwin DR, Bhowmik A, Navani N, Sennett K, Duffy SW, Wardle J, Waller J, Janes SM. Lung Screen Uptake Trial (LSUT): Randomized Controlled Clinical Trial Testing Targeted Invitation Materials. Am J Respir Crit Care Med. 2020 Apr 15;201(8):965-975. doi: 10.1164/rccm.201905-0946OC.

  PMID: 31825647 BACKGROUND

Related Links

• 4-IN THE LUNG RUN: towards INdividually tailored INvitations, screening INtervals, and INtegrated co-morbidity reducing strategies in lung cancer screening
• Cancer Intervention and Surveillance Modeling Network (CISNET) Lung Cancer Working Group.

MeSH Terms

Conditions

Lung Neoplasms; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Smoking Cessation

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Ugo Pastorino, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Head of Thoracic Surgery Division

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: September 17, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)