Recruiting

Observational Study

Sponsor:

British Columbia Cancer Agency

Code:

NCT06628102

Conditions

Lung Cancer

Pulmonary Nodule

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Chest CT Scan

Study Details

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

Study ID

NCT06628102

Start date

Aug 4, 2023

Status verified date

Oct, 2024

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

3600 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Incidental Pulmonary Nodule Arm

Nodule Follow up as per Fleischner Guidelines

Interventions

Chest CT Scan

Chest CT Scan

Primary outcome measure

  • Develop the framework to assess the lung cancer risk of Incidental Pulmonary Nodule patients [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Crista L Bartolomeu, MSc

604-675-8096cbartolomeu@bccrc.ca

Locations

BC Cancer Research, part of the Provincial Health Authority

Recruiting

Vancouver, British Columbia, Canada, V6K 2N2

Contacts

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Oct 4, 2024

Last verified

Oct, 2024

Keywords

  • Volatile Organic Compounds
  • CT Scan
  • Screening
  • Biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2024-10-04.