Cancer Lung Screening, COPD (Chronic Obstructive Pulmonary Disease), Smoking Cigarette
Conditions
Brief summary
The purpose of this study is to obtain new knowledge regarding screening for COPD. This study will use a participant's cancer screening CT scans performed as part of routine health care among current and former smokers at risk for COPD to identify participants who have had a spirometry or will have a spirometry test as part of the study to verify COPD status.
Interventions
None listed
Sponsors
University of Michigan
COPD Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Eligible for lung cancer screening by USPSTF 2021 criteria including age 50-80 years and currently or formerly smoking with at last 20 pack-years of smoking history at the time of consent. * Willingness to participate in an observational clinical trial and to be contacted about future ancillary studies that could include interventional clinical trials. * Ability to tolerate study procedures. * Ability to provide informed consent. * Clinical Lung Cancer Screening CT performed at the University of Michigan within the last year * Meets one of the three following criteria: 1. Prior Diagnosis of COPD in the EMR 2. Prior pulmonary function meeting criteria for COPD (FEV1/FVC ≤ 0.70) or 3. LAA\>1% on lung cancer screening CT scan
Exclusion criteria
* The presence of a respiratory condition other than COPD or asthma, or of a comorbid condition that in the judgment of the investigator may be the principal cause of respiratory symptoms (e.g. dyspnea or decreased exercise tolerance). * Severe asthma, which is defined as any of the following: Current (i.e. at the time of the visit) GINA Step 4 or higher therapy (medium dose ICS/LABA or high dose ICS or add-on LAMA; Medium dose = \>250 fluticasone propionate =100 fluticasone furoate, \>200 beclomethasone, \>400 budesonide, \>220 mometasone). The investigators will accept low-dose ICS/LABA or medium dose ICS. or 3 or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months or One asthma hospitalization in the past 12 months * Concurrent participation in a therapeutic trial where treatment is blinded. * Active pregnancy. Documentation of birth control will be required for pre-menopausal women. * Cognitive dysfunction that prevents the participant from completing study procedures. * BMI \> 35 kg/m2 at baseline, due to the effects of body weight on CT scan quality. * Current illicit substance abuse, including cannabis smoking. * Any illness expected to cause mortality in the next 3 years. * Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan quality. * History of thoracic radiation or thoracic surgery with resection of lung tissue. Additional temporal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine whether a case finding approach using lung cancer screening CT scans can identify patients with COPD Participants with CT scans that indicate COPD | Baseline | All participants in this study must have had a previous lung cancer screening CT scan as part of their normal medical care within one year of enrolling in this study. These pre-enrollment scans will be evaluated to determine how many scans that had been intended to identify lung cancer also indicate COPD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung Attenuation Area (LAA) Thresholds | Baseline | Percentage of participants who meet spirometric criteria for COPD and have \>1% LAA on lung cancer screening CT scan. |
| Exacerbation risk and symptom burden | Baseline | Participants will report how they experience their pulmonary health using the COPD Assessment Test (CAT) survey. The CAT is comprised of 8 questions which are each rated on a scale of 0-5, with 0 indicating no symptoms and 5 indicating worst symptoms. Ratings are then summed to generate a total score, between 0-40, with 40 indicating worst symptoms. The investigators will utilize data from the COPD Assessment Test (CAT) to describe and gain a deeper understanding of participants' symptom and exacerbation burden within this study population. |
| Severity of COPD | Baseline | Participants will be categorized into one of four GOLD categories based on their FEV1 values determined by a Pulmonary Function Test (PFT). If participants have had a PFT within the previous year, data from that test will be used. Otherwise, participants will be given a PFT during the study. GOLD I (Mild COPD) = FEV1 \>= 80% GOLD II (Moderate COPD) = 50% \<= FEV1 \< 80% GOLD III (Severe COPD) = 30% \<= FEV1 \< 50% GOLD IV (Very Severe COPD) = FEV1 \< 30% |
Countries
United States
Outcome results
None listed