Biomarkers and Genetic Factors Related to Emphysema - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00757120

Purpose

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.

Condition
Emphysema Pulmonary Disease, Chronic Obstructive

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Cross-Sectional
Official Title:	SCCOR: Alveolar and Airway Mechanisms for COPD Project 3: Membrane-Type 1 Matrix Metalloproteinase and Extracellular Matrix Metalloproteinase Inducer in Cigarette Smoke-Induced Lung Inflammation and Emphysema Pathogenesis

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Emphysema Smoking

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Biospecimen Retention: Samples With DNA

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

Estimated Enrollment:	200
Study Start Date:	October 2007
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Detailed Description:

COPD is a disease in which the lung is damaged and breathing passages become partly obstructed, making it difficult to breathe. Millions of people in the United States have COPD, and it is the fourth leading cause of death in the country. Symptoms include coughing, excess mucus production, shortness of breath and wheezing. Emphysema and chronic bronchitis are illnesses associated with COPD. Emphysema is usually the result of many years of cigarette smoking, but it remains unknown exactly how cigarette smoking causes emphysema. The purpose of this study is to examine current and former smokers who have emphysema and those who do not have emphysema to determine if certain biomarkers or genetic factors are associated with an increased risk of developing the disease. Specifically, study researchers will examine various genes and two proteins, membrane-type-1 matrix metalloproteinase (MT1-MMP) and extracellular matrix metalloproteinase inducer (EMMPRIN), to determine the role they play in the development of emphysema.

Participants will attend one study visit, which will include a medical history review, a blood collection, lung function testing, a 6-minute walk test, and a chest computed tomography (CT) scan. A portion of blood will be stored for current and future genetic research. Participants will also complete questionnaires to collect information on activities, health, and quality of life. Some participants will be invited to return for a bronchoscopy, which is a procedure that allows a doctor to sample the inside of the lungs. Study researchers will contact all participants at the end of the study to collect follow-up medical information.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

Inclusion Criteria for All Participants:

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)

Inclusion Criteria for Participants with Emphysema:

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

Inclusion Criteria for Participants without Emphysema:

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

Exclusion Criteria:

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)
Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757120

Contacts

Contact: Becky McNiff, RN	314-747-1847	rmcniff@dom.wustl.edu
Contact: Barbara Lutey, MD	314-454-8763	blutey@dom.wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Sub-Investigator: Barbara Lutey, MD
Sub-Investigator: Jeffrey Atkinson, MD

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Study Director:	Michael Holtzman, MD	Pulmonary and Critical Care, Washington University in St. Louis
Principal Investigator:	Robert Senior, MD	Pulmonary and Critical Care, Washington University in St. Louis

More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Nov 5.

Responsible Party:	Robert Senior, MD, Pulmonary and Critical Care Medicine, Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00757120 History of Changes
Other Study ID Numbers:	577, P50 HL084922-01
Study First Received:	September 19, 2008
Last Updated:	July 14, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

COPD
Cigarette Smoke-Induced Inflammation
EMMPRIN
Matrix Metalloproteinase

Additional relevant MeSH terms:

Chronic Disease
Emphysema
Pulmonary Emphysema
Inflammation
Lung Diseases
Respiration Disorders

Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on February 09, 2012