Biomarkers and Genetic Factors Related to Emphysema

NCT00757120 | Completed DMC

• 1 other identifier: 577
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

Emphysema, a common type of chronic obstructive pulmonary disease (COPD), is a long-term lung disease that is usually caused by cigarette smoking. This study will examine both current smokers and former smokers who have emphysema, as well as current and former smokers who do not have emphysema, to determine if certain factors found in the blood are related to the risk of developing emphysema.

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Keywords

COPD; Cigarette Smoke-Induced Inflammation; EMMPRIN; Matrix Metalloproteinase

Study Arms (2)

1

This group will include current and former smokers who have emphysema.

2

This group will include current and former smokers who do not have emphysema.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in this study will include current and former smokers who previously participated in the National Lung Screening Trial. Patients will also be recruited from the pulmonary clinic at Washington University School of Medicine Jacqueline Maritz Lung Center, the Barnes Jewish Hospital Pulmonary Rehabilitation Program, the Smoking Cessation Clinic of the Siteman Cancer Center, and the Pulmonary Clinic at St. Louis ConnectCare.

You may qualify if:

• Able to read and write English
• At least 30 pack-year smoking history (the equivalent of smoking a pack a day for 30 years)
• Able to participate in the informed consent process
• Relatively stable clinical status for the past six weeks (i.e., no illness in the 6 weeks before study entry)
• Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II, III, or IV COPD, as determined by post-bronchodilator spirometry values OR
• More than minimal emphysema on an acceptable-quality chest CT scan
• GOLD class I COPD or GOLD class 0 (2005 classification), as determined post-bronchodilator spirometry values AND
• No or minimal emphysema on an acceptable-quality chest CT scan

You may not qualify if:

• Pregnant
• Prisoner
• Vulnerable populations
• Recent illness (defined as increased cough, sputum production, worsening malaise, or need for unscheduled physician visit in the 6 weeks prior to enrollment)
• Congenital abnormalities of the lung or previous lung surgery
• Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated)
• CT evidence of lung disease other than emphysema (including significant fibrosis, bronchiectasis, consolidation, or indeterminate nodules)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Atkinson JJ, Lutey BA, Suzuki Y, Toennies HM, Kelley DG, Kobayashi DK, Ijem WG, Deslee G, Moore CH, Jacobs ME, Conradi SH, Gierada DS, Pierce RA, Betsuyaku T, Senior RM. The role of matrix metalloproteinase-9 in cigarette smoke-induced emphysema. Am J Respir Crit Care Med. 2011 Apr 1;183(7):876-84. doi: 10.1164/rccm.201005-0718OC. Epub 2010 Nov 5.

  PMID: 21057003 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood cells, serum, extracted RNA and DNA, lung fluid

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Holtzman, MD

  Pulmonary and Critical Care, Washington University in St. Louis

  STUDY DIRECTOR

• Steven Brody, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 22, 2008
• Study Start: October 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

US (1)