University of Michigan COPD Identification Through Lung Cancer Screening Cohort Study - MAP2
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorUniversity of Michigan
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
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.
Trial population
Patients undergoing lung cancer CT scans are at high risk for having concurrent COPD.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Current Smoker
Group B: Former Smoker
Trial outcomes
Primary outcomes
1
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.
Time frame
BaselineSecondary outcomes
1
Lung Attenuation Area (LAA) Thresholds
Percentage of participants who meet spirometric criteria for COPD and have \>1% LAA on lung cancer screening CT scan.
Time frame
Baseline2
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.
Time frame
Baseline3
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%
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
COPD Foundation
Collaborator
Source ClinicalTrials.gov