University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: COPD (Chronic Obstructive Pulmonary Disease), Cancer Lung Screening, Smoking Cigarette. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Determine whether a case finding approach using lung cancer screening CT scans can identify patients with COPD Participants with CT scans that indicate COPD [Time frame: Baseline]
Secondary outcome measures (3)
- Lung Attenuation Area (LAA) Thresholds [Time frame: Baseline]
- Exacerbation risk and symptom burden [Time frame: Baseline]
- Severity of COPD [Time frame: Baseline]
Eligibility criteria
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:
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT07482475 · HUM00271924