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RecruitingNCT06974981COPD in LCSUpdated Mar 3, 2026

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

An observational study in COPD and Chronic Obstructive Pulmonary Disease, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. Recruiting at 1 site in United States. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
420
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

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)

02

Conditions studied

  • COPD
  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • Lung Cancer Screening
  • pulmonary function
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's planned enrollment of 420 is above the median of 158 across 1,497 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University is the lead sponsor of 41 studies on the registry; 3 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 14 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
      • 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 in the EMR 2) Prior pulmonary function meeting criteria for COPD (/FVC ≤ 0.70) or 3) LAA>1% on lung cancer screening CT scan

Exclusion criteria

Exclusion Criteria:

  • The presence of a respiratory condition other than 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 will be required for pre-menopausal women
      • Cognitive dysfunction that prevents the participant from completing study procedures
      • > 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 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
420 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  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

    Time frame: 2 years

  2. Accrual rate

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

    Time frame: 2 years

  3. Intervention compliance rate

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

    Time frame: 2 years

  4. Follow-up retention rate

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

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.

Of 466 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 64. This study's planned 23 months is below that.

Counting every sponsor, half of 586 studies reached it within 26 months; a quarter within 14 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2025
First posted
May 16, 2025
StartActual
Jan 2, 2025
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2027
Last update
Mar 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06974981
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
May 16, 2025
Start date
Jan 2, 2025
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Mar 3, 2026

Study contacts

Julie Barta, MD, ATSF
Contact
julie.barta@jefferson.edu
215-955-5161
Yolanda Kry, BS
Contact
Yolanda.Kry@jefferson.edu
215-503-6234
Julie Barta, MD, ATSF
principal investigator · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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