Registry for COPD patients undergoing lung cancer screening
Leveraging Lung Cancer Screening to Optimize Screening Outcomes and COPD Management: COPD in LCS Registry
This study looks at people with COPD who are getting screened for lung cancer to see how their condition affects their screening results and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Drugs / interventions | radiation, prednisone |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06974981 on ClinicalTrials.gov |
What this trial studies
The COPD in LCS Registry aims to identify and characterize individuals with chronic obstructive pulmonary disease (COPD) who are also receiving lung cancer screening. Participants will provide clinical information, including symptom burden, lung cancer risk factors, spirometry results, imaging characteristics, and blood eosinophil counts. This observational study will help in understanding the intersection of COPD management and lung cancer screening outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-80 years with a significant smoking history who are eligible for lung cancer screening and have evidence of COPD.
Not a fit: Patients with respiratory conditions other than COPD or asthma, or those whose respiratory symptoms are primarily due to other comorbid conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of COPD in patients undergoing lung cancer screening, potentially leading to improved health outcomes.
How similar studies have performed: While there may be similar studies focusing on COPD and lung cancer screening, this specific registry approach is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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). 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 this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Julie Barta, MD, ATSF — Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Study coordinator: Julie Barta, MD, ATSF
- Email: julie.barta@jefferson.edu
- Phone: 215-955-5161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.