Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
7324 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-09-17
Study Completion Date
2026-09-30
Brief Summary
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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.
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.
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Detailed Description
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Tobacco smoking is the most relevant cause of avoidable death in all high-income countries, including the European Union and Italy. Smoking increases the risk of dying from emphysema by 10 times, doubles that of having a stroke, and increases two to four times that of being affected by a heart attack. In addition, the carcinogenic substances contained in tobacco smoke are responsible for about 90% of lung cancers, but also for most cancers of the oral cavity, larynx and bladder. Therefore, the main causes of death attributable to tobacco smoke are cancers, cardiovascular and respiratory diseases. Lung cancer is a serious and far-reaching health problem with reduced survival after 5 years. Seventy per cent of lung cancers are at an advanced clinical stage and difficult to treat when the first symptoms occur, and a certain diagnosis is made. Lung cancer mainly affects people over the age of 50, with a peak incidence around 70-75 years. Over a third of deaths attributed to smoking are between 35 and 69 years of age. For long time it was not possible to have a certain diagnosis by diagnostic tests. Only at the end of the '90s, it became clear that computed tomography allows lung cancer to be detected at an early stage (stage I), before symptoms occur.
Large-scale randomized clinical trials (RCTs) have shown that early detection of lung cancer by CT can reduce lung cancer mortality between 20% and 39%, according to the duration of the intervention. In particular, LDCT screening has been shown to significantly reduce lung cancer mortality by 8-26% for men and 26-61% in women. International lung cancer screening guidelines, currently adopted in the United States, recommend repeating LDCT at annual intervals. However, annual chest LDCT screening has heavy economic impact and can induce radiation-related damage.
Recent studies have shown that the first LDCT screening exam provides information on individual risk thus allowing the personalization of the screening interval. In particular, there are indications that screening interval can be extended safely for low-risk individuals. For example, several studies show that individuals with a negative baseline exam have a substantially lower risk than those with a positive baseline exam. A randomized prospective assessment of risk-based screening intervals therefore has the potential to improve efficiency and reduce the economic-health impact of lung cancer screening. In fact, a personalized screening protocol has a less serious economic impact, both at the instrumental level and in terms of the commitment of the radiological staff.
In this context, the RISP network aims to promote a nationwide early diagnosis program with LDCT that reduces mortality from lung cancer, and at the same time, brings benefit in primary prevention of smoking-related diseases, such as chronic obstructive pulmonary diseases (COPD) and other cardiovascular diseases. RISP will start lung screening in a gradual and controlled way, through a network of reference centers with multidisciplinary clinical competence that provide adequate coverage of the territory, and meanwhile a level of quality fitting to the standards currently achieved in the screening of other cancers (breast, cervix, colon). A systematic screening program will also increase the percentage of lung cancer patients eligible for early-stage surgical resection from the current 25% (without screening) to 50-60%.
At baseline- each volunteer will undergo:
* a baseline questionnaire (e.g. socio-demographic, smoking habits, etc) with anti-smoking counseling program that includes cytisine-based anti-smoking therapy.
* blood sampling for the assessment of the inflammatory and metabolic profile (i.e. bio-markers) (optional)
* evaluation of respiratory function and measurement of carbon monoxide (CO)
* chest LDCT without contrast
* anthropometric evaluation (e.g. weight, height, BMI, etc)
Follow-up- each randomized volunteer will undergo:
* clinical examinations of LDCT
* blood sampling and CO after 12 months of follow-up or 24 months depending on the arm to which they belong.
Imaging will be performed by volumetric acquisition with a computed tomography scanner equipped with advanced technology hardware and software, including an AI-based second reading that will be validated by a radiologists panel.
All data will be entered into a password-protected database. The protection of the identity of the subjects will be guaranteed by assigning unique participation numbers specific to the study. In a separate database, accessible only by the principal investigator or assigned team members, the unique identification number can be linked to participants' names and addresses for the purposes of local and central administrative processes such as scheduling scans, sending invitation letters, sending screening results and questionnaires for topics, and collecting follow-up information. All volunteer samples and paper/electronic files will be destroyed 15 years after completion of the study.
Participants are assured that no personal data will be published in articles, reports or other study documentation.
Randomization will be carried out using real-time automated statistical software: eligible subjects will be randomly assigned to one of the two intervention arms (A, B) with a 1:1 ratio.
Large-scale randomized clinical trials (RCTs) have shown that early detection of lung cancer by CT can reduce lung cancer mortality between 20% and 39%, according to the duration of the intervention. In particular, LDCT screening has been shown to significantly reduce lung cancer mortality by 8-26% for men and 26-61% in women. International lung cancer screening guidelines, currently adopted in the United States, recommend repeating LDCT at annual intervals. However, annual chest LDCT screening has heavy economic impact and can induce radiation-related damage.
Recent studies have shown that the first LDCT screening exam provides information on individual risk thus allowing the personalization of the screening interval. In particular, there are indications that screening interval can be extended safely for low-risk individuals. For example, several studies show that individuals with a negative baseline exam have a substantially lower risk than those with a positive baseline exam. A randomized prospective assessment of risk-based screening intervals therefore has the potential to improve efficiency and reduce the economic-health impact of lung cancer screening. In fact, a personalized screening protocol has a less serious economic impact, both at the instrumental level and in terms of the commitment of the radiological staff.
In this context, the RISP network aims to promote a nationwide early diagnosis program with LDCT that reduces mortality from lung cancer, and at the same time, brings benefit in primary prevention of smoking-related diseases, such as chronic obstructive pulmonary diseases (COPD) and other cardiovascular diseases. RISP will start lung screening in a gradual and controlled way, through a network of reference centers with multidisciplinary clinical competence that provide adequate coverage of the territory, and meanwhile a level of quality fitting to the standards currently achieved in the screening of other cancers (breast, cervix, colon). A systematic screening program will also increase the percentage of lung cancer patients eligible for early-stage surgical resection from the current 25% (without screening) to 50-60%.
At baseline- each volunteer will undergo:
* a baseline questionnaire (e.g. socio-demographic, smoking habits, etc) with anti-smoking counseling program that includes cytisine-based anti-smoking therapy.
* blood sampling for the assessment of the inflammatory and metabolic profile (i.e. bio-markers) (optional)
* evaluation of respiratory function and measurement of carbon monoxide (CO)
* chest LDCT without contrast
* anthropometric evaluation (e.g. weight, height, BMI, etc)
Follow-up- each randomized volunteer will undergo:
* clinical examinations of LDCT
* blood sampling and CO after 12 months of follow-up or 24 months depending on the arm to which they belong.
Imaging will be performed by volumetric acquisition with a computed tomography scanner equipped with advanced technology hardware and software, including an AI-based second reading that will be validated by a radiologists panel.
All data will be entered into a password-protected database. The protection of the identity of the subjects will be guaranteed by assigning unique participation numbers specific to the study. In a separate database, accessible only by the principal investigator or assigned team members, the unique identification number can be linked to participants' names and addresses for the purposes of local and central administrative processes such as scheduling scans, sending invitation letters, sending screening results and questionnaires for topics, and collecting follow-up information. All volunteer samples and paper/electronic files will be destroyed 15 years after completion of the study.
Participants are assured that no personal data will be published in articles, reports or other study documentation.
Randomization will be carried out using real-time automated statistical software: eligible subjects will be randomly assigned to one of the two intervention arms (A, B) with a 1:1 ratio.
Conditions
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Lung Cancer
COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection
Cardiovascular Diseases
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Standard arm
Volunteers with a negative baseline LDCT will repeat LDCT after the first screening with an annual interval (according to guidelines)
Group Type
EXPERIMENTAL
early lung cancer detection
Intervention Type
DIAGNOSTIC_TEST
standard treatment for early lung cancer detection with LDCT at one or two years interval
blood test
Intervention Type
OTHER
blood analysis for microRNA and other biomarkers detection
Risk-based arm
Volunteers with a negative baseline LDCT will repeat LDCT after the first screening with an interval of two years.
Group Type
EXPERIMENTAL
early lung cancer detection
Intervention Type
DIAGNOSTIC_TEST
standard treatment for early lung cancer detection with LDCT at one or two years interval
blood test
Intervention Type
OTHER
blood analysis for microRNA and other biomarkers detection
Interventions
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early lung cancer detection
standard treatment for early lung cancer detection with LDCT at one or two years interval
Intervention Type
DIAGNOSTIC_TEST
blood test
blood analysis for microRNA and other biomarkers detection
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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)
* Severe psychiatric problems
* Abuse of alcohol or other substances (including previous)
Minimum Eligible Age
55 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Presidio Ospedaliero Santo Spirito, Pescara
UNKNOWN
Sponsor Role
collaborator
IRCCS Centro di Riferimento Oncologico di Basilicata, Potenza
UNKNOWN
Sponsor Role
collaborator
Azienda Ospedaliera Pugliese Ciaccio
OTHER
Sponsor Role
collaborator
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
NETWORK
Sponsor Role
collaborator
Azienda Ospedaliera dei Colli
OTHER
Sponsor Role
collaborator
Azienda Ospedaliero-Universitaria di Parma
OTHER
Sponsor Role
collaborator
IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia, Reggio Emilia
UNKNOWN
Sponsor Role
collaborator
Istituto Nazionale dei Tumori Regina Elena, Roma
UNKNOWN
Sponsor Role
collaborator
Ospedale Policlinico San Martino
OTHER
Sponsor Role
collaborator
A.O. Ospedale Papa Giovanni XXIII
OTHER
Sponsor Role
collaborator
Azienda Ospedaliero, Universitaria Ospedali Riuniti
OTHER
Sponsor Role
collaborator
Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento
OTHER
Sponsor Role
collaborator
San Luigi Gonzaga Hospital
OTHER
Sponsor Role
collaborator
Istituto Tumori Giovanni Paolo II, BARI
UNKNOWN
Sponsor Role
collaborator
Azienda Ospedaliera per l'Emergenza Canizzaro
OTHER
Sponsor Role
collaborator
Azienda Ospedaliero-Universitaria Careggi
OTHER
Sponsor Role
collaborator
Istituto Oncologico Veneto IRCCS
OTHER
Sponsor Role
collaborator
Ugo Pastorino
OTHER
Sponsor Role
lead
Responsible Party
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Ugo Pastorino
MD, Head of Thoracic Surgery Division
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Ugo Pastorino, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Locations
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Chiara Bovolenta
Milan, MI, Italy
Site Status
RECRUITING
Countries
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Italy
Central Contacts
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Facility Contacts
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References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
https://cordis.europa.eu/project/id/848294
4-IN THE LUNG RUN: towards INdividually tailored INvitations, screening INtervals, and INtegrated co-morbidity reducing strategies in lung cancer screening
https://www.ncbi.nlm.nih.gov/books/NBK568586/pdf/Bookshelf_NBK568586.pdf
Cancer Intervention and Surveillance Modeling Network (CISNET) Lung Cancer Working Group.
Other Identifiers
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INT 292/20
Identifier Type: -
Identifier Source: org_study_id
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