Lung CancerIDEALNCT06628102
Improving Detection of Early Lung Cancer in a Diverse Population (IDEAL) Study
A study testing Chest CT Scan in people with Lung Cancer and Pulmonary Nodule, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Pulmonary Nodule
- What is being tested?
- Chest CT Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 1 siteCanada
- Study dates
- 4 Aug 2023to 31 Dec 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-80
- 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.
Who cannot join
- 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
- Unwilling to consent to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
BC Cancer Research, part of the Provincial Health Authority
Vancouver, British Columbia, V6K 2N2
Renelle L Myers, MD, 604-6758090, renelle.myers@vch.ca
Crista L Bartolomeu, MSc, 604-675-8096, cbartolomeu@bccrc.ca
About this study
Official title: Improving Detection of Early Lung Cancer in a Diverse Population
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.
Read the detailed description
Lung cancer continues to be the leading cause of cancer death in Canada and worldwide. Low-dose computed tomography (LDCT) screening has been shown to be a cost-effective measure to save lives in people who have smoked heavily based on several large randomized control trials. The evidence led to the implementation of LDCT lung cancer screening in Canada for people who have smoked heavily in the past or are still smoking. However, over 50% of patients who develop lung cancer today would not meet current screening eligibility criteria. A strategy to identify individuals who are not currently eligible for screening but are at high risk for lung cancer is urgently needed. Meanwhile, recent studies have shown that patients with incidental pulmonary nodules (IPNs), often do not meet LDCT screening criteria. These patients despite having a higher risk of lung cancer, the majority are never followed up in the clinical setting. This represents an important opportunity to address the emerging challenge for lung cancer early detection while addressing the missing link between IPNs and lung cancer.
Objective.
Our proposed study will have two important goals: (a) identify people at high risk of lung cancer who would benefit from LDCT screening but are currently ineligible; (b) provide the framework to manage patients with Incidental Pulmonary Nodules with appropriate follow-up based on accurate interpretation of the chest CT scan that is already available.
Specific Aims
(i) Develop the framework to assess the lung cancer risk of IPN patients; (ii) Develop and validate an exhaled breath test to identify high-risk individuals who do not meet current eligibility criteria for LDCT screening; (iii) Prospectively validate a panel of circulating blood proteins to personalize the management of incidental pulmonary nodules; (iv) Improve the accuracy and consistency of reading chest CT scans with incidental pulmonary nodules to improve lung cancer early detection; (v) Evaluate the health-economic benefits of a multi-modal approach to the management of incidental pulmonary nodules
Methods. In total, there will be 3600 participants recruited between both arms of the study.
As IPN patients represent a high-risk, screening ineligible and usually under-served population, we will establish a multi-provincial IPN cohort based on 3600 patients with IPNs from 3 provinces: British Columbia, Ontario and Quebec. For the Breathomics, we will conduct a comprehensive investigation of volatile organic compounds using state-of-the-art technology, and high-resolution accurate mass gas chromatography spectrometry. The breath signatures will be validated using pre-diagnostic breath samples in the IPN cohort and test the clinical utility with a point-of-care mobile device. We will validate the circulating protein panel prospectively and assess the absolute risk of lung cancer in the IPN cohort to establish the risk thresholds for clinical application. In parallel, we will develop a deep learning algorithm based on LDCT images to improve the classification of IPN. A health economic analysis will be performed on the clinical utility of these tools.
Significance:
The IPN population provides an untapped learning opportunity for us to improve lung cancer early detection. Identification of individuals who are not currently eligible for screening but are at high risk of lung cancer allows us to utilize artificial intelligence and other biomarkers to predict lung cancer from an already available single chest CT that is already available.
- Conditions
- Lung Cancer, Pulmonary Nodule
- Being tested
- Chest CT Scan
- Keywords
- Volatile Organic Compounds, CT Scan, Screening, Biomarkers
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest CT ScanDiagnostic test
Chest CT Scan
| Study group | Role | What they receive |
|---|---|---|
| Incidental Pulmonary Nodule Arm | Other | Nodule Follow up as per Fleischner Guidelines Receives: Diagnostic Test: Chest CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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
- Estimate the lung cancer incidence among those with IPNs in Canada
Measured: 4 years
Secondary outcomes (4)
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
- 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.
- Prospectively validate VOC signature on IPN cohorts at 3 Canadian provinces: British Columbia, Ontario and Quebec
Measured: 4 years
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
- Assay the informative circulating protein markers in the IPN cohorts
- 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.
Measured: 4 years
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
- 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
- Validate the deep learning model in the IPN cohort to improve the diagnostic accuracy of IPN nodules
Measured: 4 years
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
- Measure resource use and costs relevant for decision-makers implementing the new interventions for the early detection of lung cancer
- 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start4 Aug 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University, Lunenfeld Tanenbaum Research Institute, Canadian Cancer Society (CCS), University Health Network, Toronto
- Responsible party
- Principal investigator, Renelle Myers, British Columbia Cancer Agency
- Investigators
- Renelle L Myers, MD, Principal investigator, VCH, UBCRayjean Hung, PhD, Principal investigator, Sinai Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628102
- Sponsor's protocol ID
- 707695
- Acronym
- IDEAL
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2023
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers,
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Detection of Early Lung Cancer in a Diverse Population
- ClinicalTrials.gov ID
- NCT06628102
- Acronym / sponsor ID
- IDEAL / 707695
- Conditions
- Lung Cancer, Pulmonary Nodule
- Keywords
- Volatile Organic Compounds, CT Scan, Screening, Biomarkers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Laval University, Lunenfeld Tanenbaum Research Institute, Canadian Cancer Society (CCS), University Health Network, Toronto
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 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 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.
Detailed description
Lung cancer continues to be the leading cause of cancer death in Canada and worldwide. Low-dose computed tomography (LDCT) screening has been shown to be a cost-effective measure to save lives in people who have smoked heavily based on several large randomized control trials. The evidence led to the implementation of LDCT lung cancer screening in Canada for people who have smoked heavily in the past or are still smoking. However, over 50% of patients who develop lung cancer today would not meet current screening eligibility criteria. A strategy to identify individuals who are not currently eligible for screening but are at high risk for lung cancer is urgently needed. Meanwhile, recent studies have shown that patients with incidental pulmonary nodules (IPNs), often do not meet LDCT screening criteria. These patients despite having a higher risk of lung cancer, the majority are never followed up in the clinical setting. This represents an important opportunity to address the emerging challenge for lung cancer early detection while addressing the missing link between IPNs and lung cancer.
Objective.
Our proposed study will have two important goals: (a) identify people at high risk of lung cancer who would benefit from LDCT screening but are currently ineligible; (b) provide the framework to manage patients with Incidental Pulmonary Nodules with appropriate follow-up based on accurate interpretation of the chest CT scan that is already available.
Specific Aims
(i) Develop the framework to assess the lung cancer risk of IPN patients; (ii) Develop and validate an exhaled breath test to identify high-risk individuals who do not meet current eligibility criteria for LDCT screening; (iii) Prospectively validate a panel of circulating blood proteins to personalize the management of incidental pulmonary nodules; (iv) Improve the accuracy and consistency of reading chest CT scans with incidental pulmonary nodules to improve lung cancer early detection; (v) Evaluate the health-economic benefits of a multi-modal approach to the management of incidental pulmonary nodules
Methods. In total, there will be 3600 participants recruited between both arms of the study.
As IPN patients represent a high-risk, screening ineligible and usually under-served population, we will establish a multi-provincial IPN cohort based on 3600 patients with IPNs from 3 provinces: British Columbia, Ontario and Quebec. For the Breathomics, we will conduct a comprehensive investigation of volatile organic compounds using state-of-the-art technology, and high-resolution accurate mass gas chromatography spectrometry. The breath signatures will be validated using pre-diagnostic breath samples in the IPN cohort and test the clinical utility with a point-of-care mobile device. We will validate the circulating protein panel prospectively and assess the absolute risk of lung cancer in the IPN cohort to establish the risk thresholds for clinical application. In parallel, we will develop a deep learning algorithm based on LDCT images to improve the classification of IPN. A health economic analysis will be performed on the clinical utility of these tools.
Significance:
The IPN population provides an untapped learning opportunity for us to improve lung cancer early detection. Identification of individuals who are not currently eligible for screening but are at high risk of lung cancer allows us to utilize artificial intelligence and other biomarkers to predict lung cancer from an already available single chest CT that is already available.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incidental Pulmonary Nodule Arm | Other | Diagnostic Test: Chest CT ScanNodule Follow up as per Fleischner Guidelines |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50-80
- 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.
Key exclusion criteria (5 listed)
- 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
- Unwilling to consent to the study
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 |
|---|---|---|
| Chest CT ScanChest CT Scan | Diagnostic test | Incidental Pulmonary Nodule Arm |
Primary outcome
Develop the framework to assess the lung cancer risk of Incidental Pulmonary Nodule patients
Time frame: 4 years
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
4 secondary outcomes
Develop and validate an exhaled breath test to identify high-risk individuals who do not meet current eligibility criteria for LDCT screening
Time frame: 4 years
Prospectively validate a panel of circulating proteins to personalize the management of incidental pulmonary nodules
Time frame: 4 years
Improve the accuracy and consistency of reading chest CT scans with incidental pulmonary nodules to improve lung cancer early detection;
Time frame: 4 years
Evaluate the health-economic benefits of a multi-modal approach to the management of incidental pulmonary nodule
Time frame: 4 years
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 4 Oct 2024.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers,
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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.
Renelle L Myers, MD principal investigator
VCH, UBC
Rayjean Hung, PhD principal investigator
Sinai Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest CT Scan in people with Lung Cancer and Pulmonary Nodule, run by British Columbia Cancer Agency at 1 site in Canada.
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 5 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 4 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 Canada. 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 Renelle L Myers, MD (6046758096, renelle.myers@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop the framework to assess the lung cancer risk of Incidental Pulmonary Nodule patients (time frame: 4 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 4 Oct 2024.