Lung Cancer ScreeningINAIL BRICNCT06444373
Artificial Intelligence in Lung Cancer Screening
An observational study of Lung Cancer Screening and Asbestos, run by Scientific Institute San Raffaele at 1 site in Italy.
Trial summary
Single-center, non-profit, observational, retrospective study of collection of clinical and amnestic data and images to create, implement and develop a pilot model of an integrated virtual platform. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer Screening, Asbestos
- How many people
- 728 participants
- Where
- 1 siteItaly
- Study dates
- 2 Dec 2022to 30 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age \> 50 years; smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago; and/or previous professional exposure to asbestos. All subjects were enrolled in lung cancer screening program.
Who may be able to join
- Age \> 50 years;
- smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago;
- and/or previous professional exposure to asbestos;
- absence of lung cancer symptoms;
- who performed lung cancer screening after the year 2000 upon approval of the study by the relevant Etical Committee
Who cannot join
- Age \< 50 years
- never smokers
- lung cancer symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Artificial Intelligence Model in Lung Cancer Screening for the Diagnosis of Lung Nodules and Risk Stratification in Subjects With Occupational and/or Smoking Exposure
Single-center, non-profit, observational, retrospective study of collection of clinical and amnestic data and images to create, implement and develop a pilot model of an integrated virtual platform.
Read the detailed description
The project we propose is a study whose objective was to develop an artificial intelligence program integrated into a web-based platform for the optimization of the performance of lung cancer screening for the diagnosis of lung nodules and risk stratification in subjects exposed to environmental carcinogens and/or cigarette smoke.
Inclusion criteria:
Age \> 50; smokers for at least 20 pack-years (20 cigarillos a day for 20 years) or former heavy smokers if they quit less than 15 years ago; and/or previous professional exposure to asbestos; absence of lung cancer symptoms; who performed lung cancer screening after the year 2000 upon approval of the study by the relevant EC.
- Conditions
- Lung Cancer Screening, Asbestos
- Keywords
- Artificial Intelligence, Asbestos, Lung Cancer Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subjects enrolled in lung cancer screening | Actual Smokers or formers smoker; Age > 50 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AIM 1 Pilot deep learning model
Development and fine-tuning of a pilot deep learning model for automatic detection and diagnosis of screen-detected nodules for risk stratification in subjects with asbestos exposure as part of a lung cancer screening program in high-risk subjects for exposure to asbestos and smoking on retrospective data.
Measured: from enrollment to the end of treatment at 2 years
Secondary outcomes (1)
AIM 2 Clinical database
Development of an integrated system between the clinical database and several existing imaging volumetric software and risk models for the creation of a pilot platform in order to optimize the organizational management of lung cancer screening.
Measured: from enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start2 Dec 2022
- Primary completion22 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer ScreeningStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulia Veronesi, Scientific Institute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444373
- Sponsor's protocol ID
- 116/INT/2022
- Acronym
- INAIL BRIC
- Status last verified
- May 2024
- First submitted
- 30 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Artificial Intelligence Model in Lung Cancer Screening for the Diagnosis of Lung Nodules and Risk Stratification in Subjects With Occupational and/or Smoking Exposure
- ClinicalTrials.gov ID
- NCT06444373
- Acronym / sponsor ID
- INAIL BRIC / 116/INT/2022
- Conditions
- Lung Cancer Screening, Asbestos
- Keywords
- Artificial Intelligence, Asbestos, Lung Cancer Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 5 Jun 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.
Single-center, non-profit, observational, retrospective study of collection of clinical and amnestic data and images to create, implement and develop a pilot model of an integrated virtual platform.
Detailed description
The project we propose is a study whose objective was to develop an artificial intelligence program integrated into a web-based platform for the optimization of the performance of lung cancer screening for the diagnosis of lung nodules and risk stratification in subjects exposed to environmental carcinogens and/or cigarette smoke.
Inclusion criteria:
Age \> 50; smokers for at least 20 pack-years (20 cigarillos a day for 20 years) or former heavy smokers if they quit less than 15 years ago; and/or previous professional exposure to asbestos; absence of lung cancer symptoms; who performed lung cancer screening after the year 2000 upon approval of the study by the relevant EC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects enrolled in lung cancer screening | – | –Actual Smokers or formers smoker; Age > 50 years. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age \> 50 years; smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago; and/or previous professional exposure to asbestos. All subjects were enrolled in lung cancer screening program.
Key inclusion criteria (5 listed)
- Age \> 50 years;
- smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago;
- and/or previous professional exposure to asbestos;
- absence of lung cancer symptoms;
- who performed lung cancer screening after the year 2000 upon approval of the study by the relevant Etical Committee
Key exclusion criteria (3 listed)
- Age \< 50 years
- never smokers
- lung cancer symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AIM 1 Pilot deep learning model
Time frame: from enrollment to the end of treatment at 2 years
Development and fine-tuning of a pilot deep learning model for automatic detection and diagnosis of screen-detected nodules for risk stratification in subjects with asbestos exposure as part of a lung cancer screening program in high-risk subjects for exposure to asbestos and smoking on retrospective data.
1 secondary outcome
AIM 2 Clinical database
Time frame: from enrollment to the end of treatment at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer Screening and Asbestos, 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 5 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: finished, as of the sponsor's last update on 5 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AIM 1 Pilot deep learning model (time frame: from enrollment to the end of treatment at 2 years). 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 5 Jun 2024.