Improving Detection of Early Lung Cancer in a Diverse Population (IDEAL) Study

NCT06628102 | Recruiting

• 1 other identifier: 707695
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Lung Cancer; Pulmonary Nodule

Keywords

Volatile Organic Compounds; CT Scan; Screening; Biomarkers

Outcome Measures

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

  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

  4 years

• Prospectively validate a panel of circulating proteins to personalize the management of incidental pulmonary nodules

  4 years

• Improve the accuracy and consistency of reading chest CT scans with incidental pulmonary nodules to improve lung cancer early detection;

  4 years

• Evaluate the health-economic benefits of a multi-modal approach to the management of incidental pulmonary nodule

  4 years

Study Arms (1)

Incidental Pulmonary Nodule Arm

OTHER

Nodule Follow up as per Fleischner Guidelines

Diagnostic Test: Chest CT Scan

Interventions

Chest CT Scan DIAGNOSTIC_TEST

Chest CT Scan

Incidental Pulmonary Nodule Arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Laval University: collaborator
• Lunenfeld Tanenbaum Research Institute: collaborator
• Canadian Cancer Society (CCS): collaborator
• University Health Network, Toronto: collaborator

Study Sites (1)

BC Cancer Research, part of the Provincial Health Authority

Vancouver, British Columbia, V6K 2N2, Canada

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Renelle L Myers, MD

  VCH, UBC

  PRINCIPAL INVESTIGATOR

• Rayjean Hung, PhD

  Sinai Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renelle L Myers, MD

CONTACT

6046758096; renelle.myers@vch.ca

Crista L Bartolomeu, MSc

CONTACT

604-675-8096; cbartolomeu@bccrc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 4, 2024
• Study Start: August 4, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)