Lung CancerRISPNCT05766046
Lung Cancer Prevention Screening Programme in Italy
A study testing early lung cancer detection and blood test in people with Lung Cancer and COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, run by Ugo Pastorino at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, Cardiovascular Diseases
- What is being tested?
- early lung cancer detection and blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,324 participants
- Where
- 1 siteItaly
- Study dates
- 17 Sep 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Diagnosis of Lung Cancer of the Italian Pulmonary Screening Network (RISP): Comparative Analysis for the Use of Low Dose Computed Tomography and Promotion of Primary Prevention Interventions in Subjects at High Risk for Lung Cancer
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.
Read the detailed description
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.
- Conditions
- Lung Cancer, COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, Cardiovascular Diseases
- Being tested
- early lung cancer detection, blood test
- Keywords
- lung cancer, LDCT, cytisine, screening, smoking cessation, DOPC, cardiovascular diseases, primary prevention, secondary prevention, RCT, microRNA, biomarkers
- Medical subject headings
- Lung Neoplasms, Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early lung cancer detectionDiagnostic test
standard treatment for early lung cancer detection with LDCT at one or two years interval
blood testOther
blood analysis for microRNA and other biomarkers detection
| Study group | Role | What they receive |
|---|---|---|
| Standard arm | Experimental | Volunteers with a negative baseline LDCT will repeat LDCT after the first screening with an annual interval (according to guidelines) Receives: 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. Receives: Diagnostic Test: early lung cancer detection; Other: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung cancer incidence
Change in lung cancer incidence: evaluate the impact on lung cancer incidence through LDCT at annual or biennial intervals.
Measured: 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.
Measured: 5 years
Change in smoking status
Change in the percentage of smokers
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start17 Sep 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ugo Pastorino
- Sponsor type
- University, hospital or other
- Collaborators
- Presidio Ospedaliero Santo Spirito, Pescara, IRCCS Centro di Riferimento Oncologico di Basilicata, Potenza, Azienda Ospedaliera Pugliese Ciaccio, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Azienda Ospedaliera dei Colli, Azienda Ospedaliero-Universitaria di Parma, Azienda USL Reggio Emilia - IRCCS, Istituto Nazionale dei Tumori Regina Elena, Roma, Ospedale Policlinico San Martino, A.O. Ospedale Papa Giovanni XXIII, Azienda Ospedaliero, Universitaria Ospedali Riuniti, Azienda Sanitaria Universitaria Integrata del Trentino, San Luigi Gonzaga Hospital, Istituti Tumori Giovanni Paolo II, Azienda Ospedaliera per l'Emergenza Canizzaro, Azienda Ospedaliero-Universitaria Careggi, Istituto Oncologico Veneto IRCCS
- Responsible party
- Sponsor-investigator, Ugo Pastorino, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Investigators
- Ugo Pastorino, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766046
- Sponsor's protocol ID
- INT 292/20
- Acronym
- RISP
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35908731Milanese 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.
PubMed 35204320Pastorino 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.
PubMed 35091076Silva 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.
PubMed 34995141Rundo 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.
PubMed 34573951Tringali 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.
PubMed 33772489Silva 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.
PubMed 32997182Pastorino 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.
PubMed 31336289Pastorino 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.
PubMed 31168572Pastorino 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.
PubMed 30937431Gallus 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.
PubMed 30150729Silva 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.
PubMed 30026071Sozzi 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.
PubMed 24419137Pastorino 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.
PubMed 22465911National 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.
PubMed 21714641
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Diagnosis of Lung Cancer of the Italian Pulmonary Screening Network (RISP): Comparative Analysis for the Use of Low Dose Computed Tomography and Promotion of Primary Prevention Interventions in Subjects at High Risk for Lung Cancer
- ClinicalTrials.gov ID
- NCT05766046
- Acronym / sponsor ID
- RISP / INT 292/20
- Conditions
- Lung Cancer, COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, Cardiovascular Diseases
- Keywords
- lung cancer, LDCT, cytisine, screening, smoking cessation, DOPC, cardiovascular diseases, primary prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,324 participants (estimated)
- Lead sponsor
- Ugo PastorinoUniversity, hospital or other
- Collaborators
- Presidio Ospedaliero Santo Spirito, Pescara, IRCCS Centro di Riferimento Oncologico di Basilicata, Potenza, Azienda Ospedaliera Pugliese Ciaccio, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Azienda Ospedaliera dei Colli, Azienda Ospedaliero-Universitaria di Parma, Azienda USL Reggio Emilia - IRCCS, Istituto Nazionale dei Tumori Regina Elena, Roma, Ospedale Policlinico San Martino, A.O. Ospedale Papa Giovanni XXIII, Azienda Ospedaliero, Universitaria Ospedali Riuniti, Azienda Sanitaria Universitaria Integrata del Trentino, San Luigi Gonzaga Hospital, Istituti Tumori Giovanni Paolo II, Azienda Ospedaliera per l'Emergenza Canizzaro, Azienda Ospedaliero-Universitaria Careggi, Istituto Oncologico Veneto IRCCS
- Study start
- 17 Sep 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm | Experimental | Diagnostic Test: early lung cancer detection, Other: blood testVolunteers with a negative baseline LDCT will repeat LDCT after the first screening with an annual interval (according to guidelines) |
| Risk-based arm | Experimental | Diagnostic Test: early lung cancer detection, Other: blood testVolunteers with a negative baseline LDCT will repeat LDCT after the first screening with an interval of two years. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early lung cancer detectionstandard treatment for early lung cancer detection with LDCT at one or two years interval | Diagnostic test | Risk-based arm, Standard arm |
| blood testblood analysis for microRNA and other biomarkers detection | Other | Risk-based arm, Standard arm |
Primary outcome
Change in lung cancer incidence
Time frame: 3 years
Change in lung cancer incidence: evaluate the impact on lung cancer incidence through LDCT at annual or biennial intervals.
Change in lung cancer specific and overall mortality
Time frame: 5 years
Change in lung cancer specific and overall mortality: evaluate the impact on lung cancer mortality through LDCT at annual or biennial intervals.
Change in smoking status
Time frame: 3 years
Change in the percentage of smokers
Molecular risk profile through assessing the value of microRNA in blood and tissue samples
Time frame: 5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 35908731Pastorino 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.
- Background: PubMed 35204320Milanese 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.
- Background: PubMed 35091076Pastorino 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.
- Background: PubMed 34995141Silva 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.
- Background: PubMed 34573951Rundo 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.
- Background: PubMed 33772489Tringali 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.
- Background: PubMed 32997182Silva 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.
- Background: PubMed 31336289Pastorino 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.
- Background: PubMed 31168572Pastorino 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.
- Background: PubMed 30937431Pastorino 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.
- Background: PubMed 30150729Gallus 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.
- Background: PubMed 30026071Silva 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.
- 4-IN THE LUNG RUN: towards INdividually tailored INvitations, screening INtervals, and INtegrated co-morbidity reducing strategies in lung cancer screeningLink provided by the sponsor.
- Cancer Intervention and Surveillance Modeling Network (CISNET) Lung Cancer Working Group.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ugo Pastorino, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early lung cancer detection and blood test in people with Lung Cancer and COPD (Chronic Obstructive Pulmonary Disease) With Acute Lower Respiratory Infection, run by Ugo Pastorino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lung cancer incidence (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05766046, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.