University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2
Purpose
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.
Conditions
- COPD (Chronic Obstructive Pulmonary Disease)
- Cancer Lung Screening
- Smoking Cigarette
Eligibility
- Eligible Ages
- Between 50 Years and 80 Years
- Eligible Sex
- All
- Accepts 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 exclusion criteria are as follows: - Participants who present with an acute exacerbation of COPD, either solely participant-identified or that has been clinically treated, in the last 30 days can be rescreened for the study once the 30-day window from end of drug therapy has passed. - Participants who present with current use of acute antibiotics or steroids can be rescreened for the study ≥30 days after discontinuing acute antibiotics/steroids. This restriction does not apply to participants who are on chronic prednisone therapy of <10 mg per day or <20 mg every other day or participants who are currently on chronic, prophylactic, or suppressive antibiotic therapy.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Current Smoker | Participants that are currently smoking | |
| Former Smoker | Participants that have at least 20 pack-years of smoking history |
Recruiting Locations
University of Michigan
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
More Details
- NCT ID
- NCT07482475
- Status
- Recruiting
- Sponsor
- University of Michigan