University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 50 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: CT scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at ways to screen for COPD, a long-term lung disease that makes breathing hard. It uses routine lung cancer CT scans and past or new breathing tests to check for COPD in current and former smokers.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 50–80 and meet the 2021 USPSTF lung cancer screening rules. You currently smoke or used to smoke and have at least 20 pack-years of smoking, such as 1 pack a day for 20 years.
- You agree to join a study that observes your health and to be contacted about future studies, which may test treatments.
- You can safely complete the study tests.
- You can understand the study and give consent to join.
- You had a lung cancer screening CT scan at the University of Michigan within the past year.
- You have at least one of these: COPD listed in your medical record; a past breathing test showing COPD (FEV1/FVC of 0.70 or less); or more than 1% of your lung scan showing low-density areas.
Who can't join
- You have a lung condition other than COPD or asthma, or another health problem that the study doctor thinks is the main cause of your breathing symptoms.
- You have severe asthma based on your medicines, at least 3 unplanned asthma care visits in the past year, or any asthma hospital stay in the past year. The study team will check your medicine doses.
- You are in a treatment study where the treatment assignment is kept hidden, or you are pregnant. Women who have not reached menopause must provide birth control records.
- Problems with memory or thinking keep you from completing study tests, or you have an illness expected to cause death within 3 years.
- Your body mass index (BMI, a measure of weight compared with height) is over 35, or you have metal implants above the waist that could affect CT scan quality.
- You currently misuse illegal drugs, including smoking cannabis, or you have had chest radiation or surgery that removed lung tissue.
- You had a COPD flare-up in the past 30 days. You may be checked again after 30 days have passed since drug treatment ended.
- You currently take antibiotics or steroids for a short-term illness. You may be checked again at least 30 days after stopping them. This does not apply to ongoing antibiotics or ongoing prednisone below 10 mg daily or 20 mg every other day.
Simplified for readability. The official criteria below are what the study team uses.
Official 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: 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 sites (1)
MI
- University of Michigan · Ann Arbor, MI 48109Gretchen Bautisita · Study contact · 734-764-8146 · genvalen@med.umich.eduStacey Anderson, MPH · Study contact · 2482149648 · staceaan@med.umich.eduMeiLan Han, MD, MS · Principal investigatorMore trials in Ann Arbor