Registry for COPD patients undergoing lung cancer screening

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term safety of Tozorakimab in COPD patients with prior exacerbations

  This study tests two long-term dosing regimens of tozorakimab in people with COPD who have a history of flare-ups and who completed earlier studies.

  Recruiting at 5 sites Phase 3 AstraZeneca · Aix-en-Provence and 12 other locations · NCT07566195

• One-time targeted lung denervation (dNerva) for people with COPD and lung hyperinflation

  This will see if a single dNerva targeted lung denervation procedure, added to usual COPD medications, improves breathing and lung function in people with COPD who have high residual lung volume and low emphysema.

  Recruiting at 10 sites Nuvaira, Inc. · Birmingham, Alabama and 9 other locations · NCT07051707

• Thermotherapy for persistent bacterial lung infections

  This study is testing if regular heat therapy can help people with chronic lung infections get rid of stubborn bacteria that don’t respond to regular antibiotics.

  Recruiting Chronic Obstructive Pulmonary Disease Trial Network, Denmark · Hellerup, Capital Region · NCT05351242

• AERO-007: a inhaled LABA+LAMA combination for COPD through a nebulizer

  This study tests whether a nebulized LABA+LAMA combination can improve lung function in adults with COPD.

  Recruiting Phase 2 AeroRx Therapeutics Inc. · London and 1 other locations · NCT07896252

• Flutter therapy added to chest physiotherapy after CABG in COPD patients

  This study tests whether adding Flutter therapy to standard chest physiotherapy helps post-CABG patients with mild-to-moderate COPD improve breathing more than chest physiotherapy alone.

  Recruiting Foundation University Islamabad · Rawalpindi · NCT07875049

• TPB-based cadence exercise and breathing training for COPD patients

  A TPB-based program tests whether breathing training, cadence-guided walking, or both can improve lung function, exercise capacity, and quality of life in adults with COPD.

  Recruiting Fu Jen Catholic University Hospital · New Taipei City, New Taipei City and 1 other locations · NCT07860008

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.