AzTrials
AzTrials

COPDCOPD in LCSNCT06974981

Leveraging Lung Cancer Screening to Optimize Screening Outcomes and COPD Management: COPD in LCS Registry

An observational study of COPD and Chronic Obstructive Pulmonary Disease, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
COPD, Chronic Obstructive Pulmonary Disease
How many people
420 participants
Where
1 siteUnited States
Study dates
2 Jan 2025to 30 Dec 2027
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients eligible for lung cancer screening due to their age and history of tobacco use, and have COPD, chronic bronchitis, or emphysema

Who may be able to join

  • • * 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julie Barta, MD, ATSF contact

215-955-5161

julie.barta@jefferson.edu

Yolanda Kry, BS contact

215-503-6234

Yolanda.Kry@jefferson.edu

United States1 site, 1 recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Julie Barta, MD, 215-955-5161, julie.barta@jefferson.edu

    Yolanda Kry, BS, 215-503-6234, Yolanda.Kry@jefferson.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

This study is a prospective cohort study and aims to characterize COPD and lung cancer screening outcomes among individuals receiving lung cancer screening, with the primary objective of determining feasibility of an LCS-facilitated process for identifying COPD cases.

The investigators anticipate enrolling 420 participants over 2 years. All study participants will undergo collection of clinical data at baseline and at 12-15 months. Study procedures at baseline include a blood draw for complete blood count (if not available within the prior 30 days), Pulmonary Function Testing (PFT) for spirometry and six-minute walk test (if not available within the prior 12 months). All participants will receive standard of care low-dose CT for lung cancer screening through Jefferson's LCS Program. Study participants will also complete surveys at baseline including:

  • Respiratory Medication Use Questionnaire
  • Respiratory Disease and Smoke Exposure Questionnaire
  • CAPTURE Questionnaire
  • COPD Assessment Test
  • CAPTURE Questionnaire Potential participants will be recruited through the Jefferson LCS Program. The LCS Program clinical nurse navigator and research nurse navigator will assess eligibility at the time of referral to the LCS Program. Participants who have already had a PFT within 12 months will be consented and enrolled at their standard of care LCS Program appointment. The blood draw (if needed) and study questionnaires will be done immediately following the LCS Program appointment. Participants who need a first-time or updated PFT will be scheduled for a separate visit with the research nurse to provide consent, enroll on the study, and perform all study procedures.

Study participants will be followed for at least 15 months (to ascertain LCS annual adherence, defined as a repeat LDCT within 11-15 months of the prior LDCT). After enrollment completion, the Jefferson cohort will be combined with a cohort at the University of Michigan (MAP2 study, estimated n=200)

Keywords
COPD, Lung Cancer Screening, pulmonary function
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. COPD diagnosis based on meeting spirometric criteria

    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

    Measured: 2 years

  2. Accrual rate

    Will be reported using percentages and 95% exact confidence intervals.

    Measured: 2 years

  3. Intervention compliance rate

    Will be reported using percentages and 95% exact confidence intervals.

    Measured: 2 years

  4. Follow-up retention rate

    Will be reported using percentages and 95% exact confidence intervals.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2025
  2. Study start2 Jan 2025
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
420 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06974981
Sponsor's protocol ID
iRISID-2024-1246
Other IDs
JT 44147
Acronym
COPD in LCS
Status last verified
Feb 2026
First submitted
28 Mar 2025
Last updated
3 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of COPD and Chronic Obstructive Pulmonary Disease, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julie Barta, MD, ATSF (215-955-5161, julie.barta@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

COPD diagnosis based on meeting spirometric criteria (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06974981.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in