Clinical trial · Observational
University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2
NCT07482475CI-TRIAL-00106480MAP2recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Lung Screening | — | UNRESOLVED | — |
| COPD (Chronic Obstructive Pulmonary Disease) | — | UNRESOLVED | — |
| Smoking Cigarette | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Current Smoker
- description
- Participants that are currently smoking
- label
- Former Smoker
- description
- Participants that have at least 20 pack-years of smoking history
Primary outcomes (1)
- measure
- Determine whether a case finding approach using lung cancer screening CT scans can identify patients with COPD Participants with CT scans that indicate COPD
- timeFrame
- Baseline
- description
- 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 outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.