Lung Cancer Screening ProgramARIANCT06626178
Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases.
A study testing Computed tomography (CT) scan low dose, Blood sampling and Tissue sampling (lung) in people with Lung Cancer Screening Program and Artificial Intelligence (AI), run by Scientific Institute San Raffaele at 1 site in Italy.
Trial summary
The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer Screening Program, Artificial Intelligence (AI)
- What is being tested?
- Computed tomography (CT) scan low dose, Blood sampling and Tissue sampling (lung)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,840 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 1 Nov 2028
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >= 50 years old
- Active smokers
- Former smokers (from no more than 15 years)
- Pack/year >20
- Risk-prediction model from Prostate, Lung, Colorectal, and Ovarian study (PLCOm2012) >1.2%
- Provision and signature of informed consent
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- Subjects enrolled in previous lung cancer screening with the presence of lung nodules >4 mm and candidate to additional computed tomography (CT)
- Signed informed consent
- Subjects enrolled in previous lung cancer screening in this Institute with negative computed tomography (CT)
- Signed informed consent
- Patients with diagnosis or suspicious diagnosis of lung cancer candidate to surgical treatment or already submitted to it
- Patients with diagnosis of lung cancer treated with surgical resection
- Signed informed consent
Who cannot join
- Previous or concurrent neoplastic disease, excluding skin cancers
- Cognitive or other problems that could hinder the collection of informed consent
- Severe pulmonary or extra pulmonary disease
- Previous low-dose computed tomography (CT) scan in the past 12 months
- Previous high-risk positive screening subjects
- None
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- Previous high-risk negative screening subjects
- None
- Lung Cancer patients
- computed tomography (CT) scans not available at San Raffaele Hospital
- Previous neoadjuvant treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Scientific Institute Ospedale San Raffaele
Milan, 20132
Piergiorgio Muriana, MD, 0226437232 ext. +39, muriana.piergiorgio@hsr.it
Piergiorgio Muriana, MD
About this study
Official title: ARtificial Intelligence for heAlth and Prevention of Smoking-related Diseases
The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.
Read the detailed description
Interventional pilot study, single-center with additional procedures, such as completion of EORTC-QLQ-LC29, EORTC-QLQ-C30 questionnaires, motivational test, Fagestrom test, anamnestic questionnaire, spirometry, measurement of carbon monoxide, Low-dose spiral computed tomography without contrast medium, peripheral venous blood sampling for a volume of 20 ml.
The study has the main objective of traininig and validate a reliable and unbiased Artificial Intelligence (AI) algorithm that detects the presence of nodules and differentiates between malignant or benign tumor types.
The study considers patients with suspected diagnosis or with a dignosis of lung cancer, smokers and former smokers over 50 years of age at high risk of lung cancer and subjects enrolled in previous screening cohorts at this Institute.
- Being tested
- Computed tomography (CT) scan low dose, Blood sampling, Tissue sampling (lung), Spirometry, Questionnaires
- Keywords
- CT scan low-dose, Artificial Intelligence, High-risk sucjects, Lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography (CT) scan low doseDiagnostic test
The radiological investigation will be done with multi-detector-row (64 or more) computed tomography (CT) scanners at low-dose protocol. The low-dose spiral CT consists of a CT study of the chest, without the need for injection of contrast medium, characterized by less radio exposure than the standard CT of the chest with high sensitivity in detecting pulmonary nodules.
Blood samplingProcedure or surgery
Peripheral venous blood sampling (20 ml)
Tissue sampling (lung)Procedure or surgery
sampling of tumor and healthy tissue during surgery
SpirometryOther
Spirometry measurement using spirometer
QuestionnairesOther
Compilation of epidemiological questionnaire, quality of life questionnaires
Smoking cessation programOther
Study guarantee valid support for quitting smoking, which for a smoker is a more effective intervention to reduce the risk of developing lung cancer, myocardial infarction and other smoking-related diseases
Carbon monoxide measurmentOther
Measurment of Carbon monoxide (CO)
Cardiovascular primary preventionOther
Intervention done in order to find the presence of coronary calcifications
| Study group | Role | What they receive |
|---|---|---|
| High-risk screening subjects | Experimental | Ever and former male and female smokers aged over 50 years old at high risk for lung cancer, cardiovascular diseases and chronic obstructive pulmonary disease (COPD).
Additional procedures for this group:
* Spirometry
* Nurse evaluation
* Epidemiological questionnaire, Quality of Life (QoL) questionnaires
* Smoking cessation program
* Cardiovascular primary prevention
* measurement of carbon monoxide (CO)
* Blood storage
* Computed tomography (CT) scan low-dose Receives: Diagnostic Test: Computed tomography (CT) scan low dose; Procedure: Blood sampling; Other: Spirometry; Other: Questionnaires; Other: Smoking cessation program; Other: Carbon monoxide measurment; Other: Cardiovascular primary prevention |
| Previous positive high-risk screening subjects | Experimental | Subjects enrolled in previous screening cohorts in this Institute with the presence of lung nodules >4 mm. Additional procedure for this group: Computed tomography (CT) scan low-dose Receives: Diagnostic Test: Computed tomography (CT) scan low dose; Other: Smoking cessation program |
| Previous negative high-risk screening subjects | No intervention | Subjects enrolled in previous screening cohorts in this Institute with negative computed tomography (CT) scan. No additional procedures for this group. |
| Lung cancer patients | Experimental | Lung cancer patients diagnosed outside screening and treated at San Raffaele Hospital. Additional procedures for this group: biobank tissue and blood storage. Receives: Procedure: Blood sampling; Procedure: Tissue sampling (lung) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of Artificial Intelligence (AI) algorithm
To train and validate a reliable and unbiased Artificial Intelligence (AI) algorithm that detects the presence of nodules and differentiates between malignant or benign tumor types.
AUC (Area Under the Curve) values, expressed as mean and standard deviation (SD), comparing the ability in detecting the presence of nodules and differentiating the malignancy or benignity of a radiologist versus an AI algorithm, both trained on the same patient group.
Measured: from enrollment to 48 months
Secondary outcomes (1)
Multimodal program
Develop a multimodal program to enhance the prevention and the early detection of multiple smoking-related diseases Presence and absence of lung nodules > 4 mm with computed tomography (CT) scan
Measured: from enrollment to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Screening ProgramStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In the study are considered 4 different cohorts. Lung cancer patients diagnosed outside screening and treated at San Raffaele Hospital; smokers and former smokers aged over 50 years old at high risk for lung cancer, cardiovascular diseases and chronic obstructive pulmonary disease (COPD); subjects enrolled in previous screening cohorts in this Institute, which presented a computed tomography (CT) with the presence of lung nodules \>4 mm and to conclude, subjects enrolled in previous screening cohorts in this Institute, which presented a negative computed tomography (CT).
- Masking
- None (open label)
- Enrolment
- 2,840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muriana Piergiorgio, Scientific Institute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626178
- Sponsor's protocol ID
- CET 288-2024
- Acronym
- ARIA
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARtificial Intelligence for heAlth and Prevention of Smoking-related Diseases
- ClinicalTrials.gov ID
- NCT06626178
- Acronym / sponsor ID
- ARIA / CET 288-2024
- Keywords
- CT scan low-dose, Artificial Intelligence, High-risk sucjects, Lung cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,840 participants (estimated)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 3 Oct 2024 (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.
The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.
Detailed description
Interventional pilot study, single-center with additional procedures, such as completion of EORTC-QLQ-LC29, EORTC-QLQ-C30 questionnaires, motivational test, Fagestrom test, anamnestic questionnaire, spirometry, measurement of carbon monoxide, Low-dose spiral computed tomography without contrast medium, peripheral venous blood sampling for a volume of 20 ml.
The study has the main objective of traininig and validate a reliable and unbiased Artificial Intelligence (AI) algorithm that detects the presence of nodules and differentiates between malignant or benign tumor types.
The study considers patients with suspected diagnosis or with a dignosis of lung cancer, smokers and former smokers over 50 years of age at high risk of lung cancer and subjects enrolled in previous screening cohorts at this Institute.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- In the study are considered 4 different cohorts. Lung cancer patients diagnosed outside screening and treated at San Raffaele Hospital; smokers and former smokers aged over 50 years old at high risk for lung cancer, cardiovascular diseases and chronic obstructive pulmonary disease (COPD); subjects enrolled in previous screening cohorts in this Institute, which presented a computed tomography (CT) with the presence of lung nodules >4 mm and to conclude, subjects enrolled in previous screening cohorts in this Institute, which presented a negative computed tomography (CT).
| Arm | Type | Receives |
|---|---|---|
| High-risk screening subjects | Experimental | Diagnostic Test: Computed tomography (CT) scan low dose, Procedure: Blood sampling, Other: Spirometry, Other: Questionnaires, Other: Smoking cessation program, Other: Carbon monoxide measurment, Other: Cardiovascular primary preventionEver and former male and female smokers aged over 50 years old at high risk for lung cancer, cardiovascular diseases and chronic obstructive pulmonary disease (COPD). Additional procedures for this group: * Spirometry * Nurse evaluation * Epidemiological questionnaire, Quality of Life (QoL) questionnaires * Smoking cessation program * Cardiovascular primary prevention * measurement of carbon monoxide (CO) * Blood storage * Computed tomography (CT) scan low-dose |
| Previous positive high-risk screening subjects | Experimental | Diagnostic Test: Computed tomography (CT) scan low dose, Other: Smoking cessation programSubjects enrolled in previous screening cohorts in this Institute with the presence of lung nodules >4 mm. Additional procedure for this group: Computed tomography (CT) scan low-dose |
| Previous negative high-risk screening subjects | No intervention | –Subjects enrolled in previous screening cohorts in this Institute with negative computed tomography (CT) scan. No additional procedures for this group. |
| Lung cancer patients | Experimental | Procedure: Blood sampling, Procedure: Tissue sampling (lung)Lung cancer patients diagnosed outside screening and treated at San Raffaele Hospital. Additional procedures for this group: biobank tissue and blood storage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age >= 50 years old
- Active smokers
- Former smokers (from no more than 15 years)
- Pack/year >20
- Risk-prediction model from Prostate, Lung, Colorectal, and Ovarian study (PLCOm2012) >1.2%
Key exclusion criteria (11 listed)
- Previous or concurrent neoplastic disease, excluding skin cancers
- Cognitive or other problems that could hinder the collection of informed consent
- Severe pulmonary or extra pulmonary disease
- Previous low-dose computed tomography (CT) scan in the past 12 months
- Previous high-risk positive screening subjects
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 |
|---|---|---|
| Computed tomography (CT) scan low doseThe radiological investigation will be done with multi-detector-row (64 or more) computed tomography (CT) scanners at low-dose protocol. The low-dose spiral CT consists of a CT study of the chest, without the need for injection of contrast medium, characterized by less radio exposure than the standard CT of the chest with high sensitivity in detecting pulmonary nodules. | Diagnostic test | High-risk screening subjects, Previous positive high-risk screening subjects |
| Blood samplingPeripheral venous blood sampling (20 ml) | Procedure or surgery | High-risk screening subjects, Lung cancer patients |
| Tissue sampling (lung)sampling of tumor and healthy tissue during surgery | Procedure or surgery | Lung cancer patients |
| SpirometrySpirometry measurement using spirometer | Other | High-risk screening subjects |
| QuestionnairesCompilation of epidemiological questionnaire, quality of life questionnaires | Other | High-risk screening subjects |
| Smoking cessation programStudy guarantee valid support for quitting smoking, which for a smoker is a more effective intervention to reduce the risk of developing lung cancer, myocardial infarction and other smoking-related diseases | Other | High-risk screening subjects, Previous positive high-risk screening subjects |
| Carbon monoxide measurmentMeasurment of Carbon monoxide (CO) | Other | High-risk screening subjects |
| Cardiovascular primary preventionIntervention done in order to find the presence of coronary calcifications | Other | High-risk screening subjects |
Primary outcome
Creation of Artificial Intelligence (AI) algorithm
Time frame: from enrollment to 48 months
To train and validate a reliable and unbiased Artificial Intelligence (AI) algorithm that detects the presence of nodules and differentiates between malignant or benign tumor types. AUC (Area Under the Curve) values, expressed as mean and standard deviation (SD), comparing the ability in detecting the presence of nodules and differentiating the malignancy or benignity of a radiologist versus an AI algorithm, both trained on the same patient group.
1 secondary outcome
Multimodal program
Time frame: from enrollment to 48 months
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 3 Oct 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed tomography (CT) scan low dose, Blood sampling and Tissue sampling (lung) in people with Lung Cancer Screening Program and Artificial Intelligence (AI), run by Scientific Institute San Raffaele 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 13 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 3 Oct 2024. 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?
Contact Piergiorgio Muriana, MD (0226437232 ext. +39, muriana.piergiorgio@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of Artificial Intelligence (AI) algorithm (time frame: from enrollment to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.