RECRUITING

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

Conditions

COPD - Chronic Obstructive Pulmonary Disease The COPD in LCS Registry will identify and characterize individuals who have functional or radiographic evidence of COPD and are receiving lung cancer screening

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-02

Study Completion:2027-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06974981

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Julie Barta, Associate Professor

CONTACT

215-955-5161

julie.barta@jefferson.edu

Yolanda Kry, Bachelor of Science

CONTACT

215-503-6234

Yolanda.Kry@jefferson.edu

Study Locations (Sites)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-02

Study Completion Date2027-12-30

Study Record Updates

Study Start Date2025-01-02

Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

The COPD in LCS Registry will identify and characterize individuals who have functional or radiographic evidence of COPD and are receiving lung cancer screening

Additional Relevant MeSH Terms

COPD - Chronic Obstructive Pulmonary Disease