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

NCT06974981 | Recruiting

• 2 other identifiers: iRISID-2024-1246JT 44147
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Chronic Obstructive Pulmonary Disease

Keywords

COPD; Lung Cancer Screening; pulmonary function

Outcome Measures

Primary Outcomes (4)

• 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

  2 years

• Accrual rate

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

  2 years

• Intervention compliance rate

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

  2 years

• Follow-up retention rate

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

  2 years

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \* 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AstraZeneca: collaborator
• Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Links

• Racial Differences in Lung Cancer Screening Beliefs and Screening Adherence. Clinical lung cancer. 2021;22(6):570-8. doi:
• Nonmalignant Surgical Resection Among Individuals with Screening-Detected Versus Incidental Lung Nodules. Clinical lung cancer. 2023. doi:

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood eosinophils will be obtained from study participants. Stored clinical and survey data will be stored electronically on the Redcap database for at least 5 years and may be used for future research. Future research outside the scope of this protocol will be reviewed by the IRB prior to proceeding. No genetic testing is performed in this study.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Barta, MD, ATSF

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Barta, MD, ATSF

CONTACT

215-955-5161; julie.barta@jefferson.edu

Yolanda Kry, BS

CONTACT

215-503-6234; Yolanda.Kry@jefferson.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: May 16, 2025
• Study Start: January 2, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)