SPIROMICS Study of Early COPD Progression (SOURCE) (SOURCE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05033990|
Recruitment Status : Recruiting
First Posted : September 5, 2021
Last Update Posted : April 28, 2022
This is an observational study of 600 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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||SPIROMICS Study of Early COPD Progression (SOURCE)|
|Actual Study Start Date :||September 8, 2021|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||April 2025|
Participants with no smoking history (< 100 cigarettes in lifetime); post-bronchodilator FEV1/FVC > 0.70; post-bronchodilator FEV1 > 80% predicted; and post-bronchodilator FVC > 80% predicted.
Participants graded as GOLD 0 by the GOLD grading system: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC > 0.70 and FEV1 > 80% predicted.
GOLD stands for the Global initiative for Chronic Obstructive Lung Disease.
Preserved Ratio Impaired Spirometry (PRISm)
Participants with with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC > 0.70 and FEV1 < 80% predicted.
Gold 1 - 2
Participants graded as GOLD 0 by the GOLD grading system: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC < 0.70 and FEV1 50-80% predicted.
- PRM fSAD [ Time Frame: Year 2-5 ]Parametric Response Mapping captures the change in lung density between matched inspiratory and expiratory images thereby enabling the distinction between normal lung parenchyma (PRMNORM), emphysema (PRMEMPH), and non-emphysematous air trapping referred to as functional small airway disease (PRMfSAD).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05033990
|Contact: Lori A Bateman, MSfirstname.lastname@example.org|
|Contact: David Couper, PhDemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35205|
|Contact: Mark Dransfield, MD firstname.lastname@example.org|
|Contact: Sonya Hardy (205) 966-6601 email@example.com|
|United States, California|
|University of California Los Angeles||Not yet recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Igor Barjaktarevic, MD, PhD|
|Contact: Roslynn Marzan-McGill, CPT, CCRP (310) 825-2616 firstname.lastname@example.org|
|University of California, San Francisco||Not yet recruiting|
|San Francisco, California, United States, 94143|
|Contact: Prescott G. Woodruff, MD, MPH 415-479-3370 email@example.com|
|Contact: Jennipher Jose Jennipher.Jose@ucsf.edu|
|United States, Colorado|
|National Jewish Health||Not yet recruiting|
|Denver, Colorado, United States, 80206|
|Contact: Russell Bowler, MD, PhD|
|Contact: Alex Johnson, MSW (303) 398-1943 firstname.lastname@example.org|
|United States, Illinois|
|University of Illinois Chicago||Not yet recruiting|
|Chicago, Illinois, United States, 60608|
|Contact: Jerry Krishnan, MD, PhD|
|Contact: Julie Delisa (855) 494-3393 email@example.com|
|United States, Iowa|
|University of Iowa||Not yet recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Alejandro Comellas, MD|
|Contact: Mike Wurth (319) 356-1785 firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Bayview Medical Center||Not yet recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Nadia Hansel, MD, MPH|
|Contact: Cheryl Clare (410) 550-2864 Cdaniel9@jhu.edu|
|United States, Michigan|
|University of Michigan||Not yet recruiting|
|Ann Arbor, Michigan, United States, 48130|
|Contact: Meilan Han, MD, MPH email@example.com|
|Contact: Crystal Cutlip (734) 647-6399 firstname.lastname@example.org|
|United States, New York|
|Columbia University||Not yet recruiting|
|New York, New York, United States, 10032|
|Contact: R. Graham Barr, MD, PhD|
|Contact: Michael Sheffey (347) 835- 8180 email@example.com|
|United States, North Carolina|
|Wake Forest||Not yet recruiting|
|Winston-Salem, North Carolina, United States, 27104|
|Contact: Stephen Peters, MD, PhD|
|Contact: Marissa Millard (336) 713-9190 firstname.lastname@example.org|
|United States, Pennsylvania|
|Temple University||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 10140|
|Contact: Gerald Criner, MD, FACP|
|Contact: Keith Johnson (215) 707-4547 email@example.com|
|United States, Utah|
|University of Utah||Not yet recruiting|
|Salt Lake City, Utah, United States, 84108|
|Contact: Paine Robert, MD|
|Contact: Martin Villegas (801) 581-6496 firstname.lastname@example.org|
|Principal Investigator:||Fernando J Martinez, MD, MS||Weill Medical College at Cornell University|
|Principal Investigator:||MeiLan K Han, MD,MS||University of Michigan|
|Principal Investigator:||Jeffrey L Curtis, MD||University of Michigan|