RECRUITING

SPIROMICS Study of Early COPD Progression (SOURCE)

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Conditions

COPD, Early-Onset

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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

This is an observational study of 1000 participants to further define the nature of early chronic obstructive pulmonary disease (COPD) in younger, at-risk individuals. The study has three main goals: * To use CT scan imaging to identify which smokers will develop COPD. * To identify biomarkers predictive of smokers that will develop COPD. * To determine if sputum (phlegm) can be analyzed to predict which smokers will develop COPD. Procedures (methods): All participants will undergo study related questionnaires assessing medical history, smoke exposure and use, medication use, social and behavioral health, pulmonary symptoms, food frequency, and will provide nasal swab, blood, stool, and urine samples, pulmonary function testing to determine function, sputum induction to provide a sputum sample for airway biospecimen analysis, and CT imaging of the lungs.

Official Title

SPIROMICS Study of Early COPD Progression (SOURCE)

Quick Facts

Study Start:2021-09-08
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05033990

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:30 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 40 of the 1000 will be healthy controls: ages 30-55 years; with no smoking history (\< 100 cigarettes in lifetime), including vaping and cannabis use; pre-bronchodilator FEV1/FVC \> 0.70; pre-bronchodilator FEV1 \> 80% predicted; pre-bronchodilator FVC \> 80% predicted; Chronic Airway Assessment Test (CAAT) score \< 10. Willingness to also participate in the bronchoscopy sub-study is only required of the 20 healthy controls recruited from the clinical centers participating in the sub-study.
  2. * Approximately one-third of the 960 will be GOLD 0 participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \> 0.70 and FEV1 \> 80% predicted.
  3. * Approximately one-third of the 960 will be Preserved Ratio Impaired Spirometry (PRISm) participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \> 0.70 and FEV1 \< 80% predicted.
  4. * Approximately one-third of the 960 will be GOLD 1-2 participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \< 0.70 and FEV1 \> 50% predicted.
  1. * Severe asthma, which is defined as any of the following:
  2. * Current (i.e., at the time of the visit) Global Initiative for Asthma (GINA) Step 4 or higher therapy (medium dose inhaled corticosteroids (ICS)/long-acting beta agonist (LABA) or high dose ICS or add-on long-acting muscarinic agonist (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. * Three or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months; or
  4. * One asthma hospitalization in the past 12 months.
  5. * Concurrent participation in a therapeutic trial where treatment is blinded.
  6. * Active pregnancy at the time of the baseline visit or planning to become pregnant during the course of the study. This special population is being excluded to minimize potential for fetal radiation exposure.
  7. * Cognitive dysfunction that prevents the participant from completing study procedures.
  8. * BMI \> 35.0 kg/m\^2 at baseline, due to the effects of body weight on CT scan imaging quality.
  9. * The presence of a respiratory condition other than COPD (including chronic bronchitis and emphysema) or asthma, such as interstitial lung disease or pulmonary fibrosis, 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).
  10. * Any illness expected to cause mortality in the next three years.
  11. * Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan image quality.
  12. * History of thoracic radiation or thoracic surgery with resection of lung tissue.
  13. * Known HIV/AIDS infection.
  14. * Current illicit substance abuse, excluding marijuana.
  15. * History of or current use of IV Ritalin.
  16. * History of or current use of heroin.
  17. * History of illegal IV drug use within the last 10 years or more than 5 instances of illegal IV drug use ever.

Contacts and Locations

Study Contact

Lori A Bateman, MS
CONTACT
9199623266
lbateman@email.unc.edu
David Couper, PhD
CONTACT
9199623229
david_couper@unc.edu

Principal Investigator

Fernando J Martinez, MD, MS
PRINCIPAL_INVESTIGATOR
Weill Medical College at Cornell University
MeiLan K Han, MD,MS
PRINCIPAL_INVESTIGATOR
University of Michigan
Jeffrey L Curtis, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35205
United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
United States
University of California Los Angeles
Los Angeles, California, 90095
United States
University of California, San Francisco
San Francisco, California, 94143
United States
National Jewish Health
Denver, Colorado, 80206
United States
University of Illinois Chicago
Chicago, Illinois, 60608
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States
University of Michigan
Ann Arbor, Michigan, 48130
United States
Columbia University
New York, New York, 10032
United States
Weill Cornell Medical Center
New York, New York, 10065
United States
Wake Forest
Winston-Salem, North Carolina, 27104
United States
Temple University
Philadelphia, Pennsylvania, 10140
United States
University of Utah
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • Fernando J Martinez, MD, MS, PRINCIPAL_INVESTIGATOR, Weill Medical College at Cornell University
  • MeiLan K Han, MD,MS, PRINCIPAL_INVESTIGATOR, University of Michigan
  • Jeffrey L Curtis, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

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 Date2021-09-08
Study Completion Date2025-04

Study Record Updates

Study Start Date2021-09-08
Study Completion Date2025-04

Terms related to this study

Additional Relevant MeSH Terms

  • COPD, Early-Onset