Clinical trial NCT06974981: Leveraging Lung Cancer Screening to Optimize Screening Outcomes and COPD Management: COPD in LCS Registry
Official title: Leveraging Lung Cancer Screening to Optimize Screening Outcomes and COPD Management: COPD in LCS Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD - Chronic Obstructive Pulmonary Disease
Keywords: The COPD in LCS Registry will identify and characterize individuals who have functional or radiographic evidence of COPD and are receiving lung cancer screening
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2025-05-16
Enrollment: 420
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients eligible for lung cancer screening due to their age and history of tobacco use, and have COPD, chronic bronchitis, or emphysema

Brief summary: 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.


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). 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

Primary outcomes:
measure: COPD diagnosis based on meeting spirometric criteria
timeFrame: 2 years
measure: Accrual rate
timeFrame: 2 years
measure: Intervention compliance rate
timeFrame: 2 years
measure: Follow-up retention rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References: