400 Participants NeededMy employer runs this trial

AI Test for Lung Cancer Risk

AS
ES
Overseen ByErica Seltzer, DrPh, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Illinois at Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Artificial Intelligence (AI) can predict the risk of developing lung cancer over the next three years. It involves two groups: one that has already undergone lung cancer screening and another that has not. Participants will receive either an AI-based prediction (AI-Inferred Lung Cancer Risk Prediction) using past CT scans and health data or a lab test using DNA from their blood. The trial is best suited for individuals who have smoked for 20 years or more and either currently smoke or quit within the last 15 years. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could revolutionize lung cancer prediction and prevention.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that adjuvant hormone therapy for cancer is allowed, suggesting some medications might be permitted.

What prior data suggests that this AI-based prediction method is safe for evaluating lung cancer risk?

Research has shown that AI tools for predicting lung cancer risk are promising. Researchers have tested these AI models to assess their ability to predict lung cancer development by analyzing data from scans and other medical tests. They have found these models to be more accurate than older methods in identifying at-risk individuals.

Regarding safety, the AI tool poses no physical side effects because it only analyzes existing medical data like CT scans. It does not involve taking a drug or undergoing a procedure. The AI tool assists doctors in determining who might need further testing or treatment.

Overall, using AI to predict lung cancer risk is considered safe for participants, as it relies on data analysis rather than invasive processes.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a novel way to assess lung cancer risk using artificial intelligence (AI). Unlike the standard low-dose CT (LDCT) scans, which are the current go-to method for screening, the AI approach analyzes CT imaging alongside clinical features to predict risk more precisely. Additionally, for those who've never had an LDCT scan, there's an innovative test analyzing circulating DNA fragmentomics, offering a new avenue for early detection. These methods promise to enhance accuracy and potentially catch lung cancer earlier, which could be a game-changer in treatment outcomes.

What evidence suggests that this trial's AI-based prediction could be effective for assessing lung cancer risk?

Research has shown that AI tools hold promise in predicting lung cancer risk. In this trial, participants in the screen-established cohort will receive a research-use-only (RUO) multimodal artificial intelligence risk prediction based on lung screening CT imaging and clinical features. Studies have demonstrated that an AI model called Sybil is highly accurate, identifying high-risk and low-risk patients with accuracy rates between 86% and 94%. This model can predict lung cancer risk from just one low-dose CT scan and has proven effective up to six years in advance. Meanwhile, participants in the screen-naïve cohort will receive a regulatory-cleared laboratory-developed test for lung cancer screening, circulating DNA fragmentomics. Another study found that when the AI correctly identified all cancer cases within one year, it also classified 68.1% of non-cancer cases as low risk, reducing unnecessary worry. These findings suggest that AI could be a powerful tool for early lung cancer detection and personalized screening.678910

Who Is on the Research Team?

AS

Ameen Salahudeen, MD, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for adults aged 50-80 who are eligible for lung cancer screening, have a history of heavy smoking (20 pack-years), and currently smoke or quit within the last 15 years. Participants must be able to understand study procedures, give consent themselves, and not be pregnant or breastfeeding.

Inclusion Criteria

I am able to understand and follow all study instructions.
* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. Consent provided by a legally authorized representative is not permitted in this protocol.
I am not pregnant or breastfeeding and have a recent negative pregnancy test.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

12 months
Multiple visits for recruitment and eligibility assessment

Intervention

Participants receive AI-based lung cancer risk prediction tests and return of results

Day 1
1 visit (in-person)

Follow-up

Participants are monitored for patient-reported outcomes and adherence to LDCT and smoking cessation

1 year post-return of results
Surveys and assessments at multiple intervals

What Are the Treatments Tested in This Trial?

Interventions

  • AI-Inferred Lung Cancer Risk Prediction

Trial Overview

The study is testing an AI-based tool that predicts a person's risk of developing lung cancer over the next three years. It will compare people new to screening with those already being screened, focusing on how patients feel about receiving their AI-predicted risk results.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Screen-naïve cohortExperimental Treatment1 Intervention
Group II: Screen-established cohortExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Citations

The Impact of Artificial Intelligence on Lung Cancer Diagnosis ...

In summary, AI has demonstrated substantial promise across multiple facets of lung cancer diagnosis, including imaging, pathology, and risk ...

New MIT AI Tool Predicts Lung Cancer Risk Years Before ...

Validation studies reported that Sybil is between 86 and 94 percent accurate in distinguishing between high-risk and low-risk patients within a ...

Deep Learning Model Estimates Cancer Risk of Lung ...

At 100% sensitivity for cancers diagnosed within 1 year, the deep learning model classified 68.1% of benign cases as low risk compared to 47.4% ...

Development of AI-Driven Advanced Lung Cancer Screening ...

Our research project is driven by the hypothesis that a comprehensive analysis, harnessing clinical information and advanced AI models, including Machine ...

A new AI tool could predict lung cancer risk before ...

A new AI tool could predict lung cancer risk before symptoms appear. A doctor explains how it works. Click the link below for more.

A new AI tool could predict lung cancer risk before ...

The AI platform integrates data from mammograms, CT scans, and MRIs, assessing tissue density, vascular changes, and cellular abnormalities. It ...

Lung Cancer Risk Accurately Predicted By AI Model

A deep-learning AI model, Sybil, can predict who will go on to develop lung cancer after one and six years based on one low-dose CT scan.

AI tools like Sybil poised to improve lung cancer screening ...

Improving lung cancer risk prediction. Risk models that identify candidates for screening based on factors beyond age and smoking history and ...

Lung cancer risk prediction using augmented machine ...

This work presents a holistic method for lung cancer risk prediction through the combination of data augmentation methods with machine learning ...

Artificial Intelligence and Lung Cancer: Impact on Improving ...

AI models have exhibited promise in utilizing biomarkers and tumor markers as supplementary screening tools, effectively enhancing the specificity and accuracy ...