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

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.

Study Overview

• Status: Recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease); Smoking Cigarette; Cancer Lung Screening

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Gretchen Bautisita; Phone Number: 734-764-8146; Email: genvalen@med.umich.edu
      • Contact: Stacey Anderson, MPH; Phone Number: 2482149648; Email: staceaan@med.umich.edu
      • Principal Investigator: MeiLan Han, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing lung cancer CT scans are at high risk for having concurrent COPD.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Current Smoker; Participants that are currently smoking
Former Smoker; Participants that have at least 20 pack-years of smoking history

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether a case finding approach using lung cancer screening CT scans can identify patients with COPD Participants with CT scans that indicate COPD	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Attenuation Area (LAA) Thresholds	Percentage of participants who meet spirometric criteria for COPD and have >1% LAA on lung cancer screening CT scan.	Baseline
Severity of COPD	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%	Baseline
Exacerbation risk and symptom burden	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.	Baseline

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: COPD Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: March 14, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 21, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Behavior; Smoking; Tobacco Smoking; Tobacco Use; Pulmonary Disease, Chronic Obstructive; Cigarette Smoking
• Other Study ID Numbers: HUM00271924

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No