Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628102
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-10-10
Brief Title:
Improving Detection of Early Lung Cancer in a Diverse Population IDEAL Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving Detection of Early Lung Cancer in a Diverse Population
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEAL
Brief 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 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 raceethnicity 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 IPNs 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None