NCT06974981 · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Leveraging Lung Cancer Screening to Optimize Screening Outcomes and COPD Management: COPD in LCS Registry
(COPD in LCS)
What this study is about
The COPD in LCS Registry will identify and characterize individuals who have functional or radiographic evidence of COPD and are receiving lung cancer screening. Clinical information will be obtained from study participants including symptom burden, lung cancer risk, spirometry, imaging characteristics, and peripheral blood eosinophils.
View original scientific description
The COPD in LCS Registry will identify and characterize individuals who have functional or radiographic evidence of COPD and are receiving lung cancer screening. Clinical information will be obtained from study participants including symptom burden, lung cancer risk, spirometry, imaging characteristics, and peripheral blood eosinophils.
Primary outcome measures
COPD diagnosis based on meeting spirometric criteria
Time frame: 2 years
Will be based on meeting spirometric criteria for COPD (FEV\^1/FVC =\< 0.7) and have \>1% low attenuation area on low-dose CT for LCS
Accrual rate
Time frame: 2 years
Will be reported using percentages and 95% exact confidence intervals.
Intervention compliance rate
Time frame: 2 years
Will be reported using percentages and 95% exact confidence intervals.
Follow-up retention rate
Time frame: 2 years
Will be reported using percentages and 95% exact confidence intervals.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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). We 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
- 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
Where
- Philadelphia, Pennsylvania
Collaborators
AstraZeneca
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2026 · Source of record for eligibility and locations