RecruitingNCT07482475

University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2


Sponsor

University of Michigan

Enrollment

200 participants

Start Date

Jul 15, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 80 Years

Inclusion Criteria9

  • 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:
  • Prior Diagnosis of COPD in the EMR
  • Prior pulmonary function meeting criteria for COPD (FEV1/FVC ≤ 0.70) or
  • LAA\>1% on lung cancer screening CT scan

Exclusion Criteria14

  • 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). We 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.
  • 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.

Locations(1)

University of Michigan

Ann Arbor, Michigan, United States

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NCT07482475


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