Improving Detection of Early Lung Cancer in a Diverse Population (IDEAL) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorBritish Columbia Cancer Agency
About this trial
The goal of this trial is to (a) identify people at high risk of lung cancer who would benefit from LDCT screening but are currently ineligible based on current lung cancer screening criteria (b) provide the framework to manage patients with Incidental Pulmonary Nodules (IPNs) with appropriate follow-up based on accurate interpretation of the Chest CT scan that is already available and (c) develop a simple, point-of-care, minimally invasive test, focusing on the breath and circulating blood proteins, to detect lung cancer, and develop a method to differentiate between cancerous and non-cancerous nodules using a single. Participants will be asked to answer a questionnaire regarding their age, race/ethnicity, smoking history, and residential history if they have ever been told they have chronic obstructive pulmonary disease (COPD), high blood pressure, education level, medications and height and weight. Participants will then be asked to give a breath sample via the breath collection device. All this information will be collected before the breath collection. After that, participants will give 1-2 tablespoons of blood. CT scans with IPN(s) will be reviewed and run through a computer detection software to identify nodules, followed up as per current clinical guidelines.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to consent
Chest CT positive for nodule equal to or greater than 6mm
No additional other cancer- (outside of lung cancer for group 1)
Must be able to abstain from smoking tobacco for 24 hours prior to the breath test.
Disqualifiers
Too sick to provide a breath sample
you have smoked in the last 24 hours
You are pregnant
You have been diagnosed with a respiratory infection in the last 3 months
Trial design
Design model
Single group
Treatments tested in this trial
Chest CT Scan
Diagnostic testChest CT Scan
Treatment groups
3,600 Participants
are divided into 1 treatment groupGroup A: Incidental Pulmonary Nodule ArmOther 1 intervention
Trial outcomes
Primary outcomes
1
Develop the framework to assess the lung cancer risk of Incidental Pulmonary Nodule patients
Aim 1: Develop the framework within the Canadian context to promote the diagnosis of early-stage lung cancert hat can work synergistically with organized lung cancer screening programs to improve outcome of patients with lung cancer, using IPN population as a learning example. 1. Establish the cohorts of individuals with incidental pulmonary nodules (IPN) across 3 provinces in Canada, focused on those who do not fit current LDCT screening criteria, with a total of 3600 IPN patients with incidental pulmonary nodules at least 6mm in diameter 2. Estimate the lung cancer incidence among those with IPNs in Canada
Time frame
4 yearsSecondary outcomes
1
Develop and validate an exhaled breath test to identify high-risk individuals who do not meet current eligibility criteria for LDCT screening
Aim 2: Develop and validate an exhaled breath test to identify high risk individuals who do not meet current eligibility criteria for LDCT screening 1. Identify the VOC signature that distinguishes early lung cancer versus non-lung cancer patients with 1:1:1 ratio of lung cancer cases, IPN patients without lung cancer, and healthy controls with frequency matching with 200 individuals in each group. 2. Prospectively validate VOC signature on IPN cohorts at 3 Canadian provinces: British Columbia, Ontario and Quebec
Time frame
4 years2
Prospectively validate a panel of circulating proteins to personalize the management of incidental pulmonary nodules
Aim 3: Prospectively validate the INTEGRAL panel of blood-based biomarkers to personalize the management of incidental pulmonary nodules based on their lung cancer risk and nodule malignancy probability 1. Assay the informative circulating protein markers in the IPN cohorts 2. Estimate the absolute risk threshold based on the integrated model for IPN patients that as equivalence to heavy smokers in LDCT screening programs, and estimate nodule malignancy probability that would warrant clinical follow-up with optimized benefit-harm ratio.
Time frame
4 years3
Improve the accuracy and consistency of reading chest CT scans with incidental pulmonary nodules to improve lung cancer early detection;
Aim 4 Improve the accuracy and consistency of reading chest CT scans with incidental pulmonary nodules 1. Train a deep learning model based on multi-angled 2-dimensional and 3-dimensional approaches using 4 existing LDCT screening programs, including the National Lung Screening Study (NLST), the Early Detection of Lung Cancer - a Pan-Canadian Study (PanCan), and the International Early Lung Cancer Action Program (IELCAP)-Toronto site, and the International Lung Screening Trial (ILST), with a total of 23,200 screening participants with LDCT images available 2. Validate the deep learning model in the IPN cohort to improve the diagnostic accuracy of IPN nodules
Time frame
4 years4
Evaluate the health-economic benefits of a multi-modal approach to the management of incidental pulmonary nodule
Aim 5: Evaluate the health economic benefits of a multi-modal approach to management of incidental pulmonary nodules 1. Measure resource use and costs relevant for decision-makers implementing the new interventions for the early detection of lung cancer 2. Estimate the effectiveness and cost-effectiveness of: the novel breath test, the INTEGRAL blood panel, the AI model for quantitative imaging analysis, compared to standard care for IPN patients
Time frame
4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
British Columbia Cancer Agency
Lead sponsor
Laval University
Collaborator
Lunenfeld Tanenbaum Research Institute
Collaborator
Canadian Cancer Society (CCS)
Collaborator
University Health Network, Toronto
Collaborator
Source ClinicalTrials.gov