Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases.

NCT06626178 | Recruiting DMC

• 1 other identifier: CET 288-2024
• Study Type: interventional
• Target: 2,840
• Locations: 1 country
• Sites: 1

Brief Summary

The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.

Conditions

Lung Cancer Screening Program; Artificial Intelligence (AI)

Keywords

CT scan low-dose; Artificial Intelligence; High-risk sucjects; Lung cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  from enrollment to 48 months

Secondary Outcomes (1)

• Multimodal program

  from enrollment to 48 months

Study Arms (4)

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

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

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.

Procedure: Blood sampling; Procedure: Tissue sampling (lung)

Interventions

Computed tomography (CT) scan low dose DIAGNOSTIC_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.

High-risk screening subjects; Previous positive high-risk screening subjects

Blood sampling PROCEDURE

Peripheral venous blood sampling (20 ml)

High-risk screening subjects; Lung cancer patients

Tissue sampling (lung) PROCEDURE

sampling of tumor and healthy tissue during surgery

Lung cancer patients

Spirometry OTHER

Spirometry measurement using spirometer

High-risk screening subjects

Questionnaires OTHER

Compilation of epidemiological questionnaire, quality of life questionnaires

High-risk screening subjects

Smoking cessation program OTHER

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

High-risk screening subjects; Previous positive high-risk screening subjects

Carbon monoxide measurment OTHER

Measurment of Carbon monoxide (CO)

High-risk screening subjects

Cardiovascular primary prevention OTHER

Intervention done in order to find the presence of coronary calcifications

High-risk screening subjects

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• \- None
• Previous high-risk negative screening subjects
• Subjects enrolled in previous lung cancer screening in this Institute with negative computed tomography (CT)
• Signed informed consent
• \- None
• Lung Cancer patients
• 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

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead

Study Sites (1)

Scientific Institute Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Tomography, X-Ray Computed; Radionuclide Imaging; Blood Specimen Collection; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Diagnostic Techniques, Radioisotope; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Piergiorgio Muriana, MD

CONTACT

0226437232; muriana.piergiorgio@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No blinding in this study
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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).

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: October 3, 2024

Record last verified: 2024-10

Locations

IT (1)