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Biomarkers and Genetic Factors Related to Emphysema

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ClinicalTrials.gov Identifier: NCT00757120
Recruitment Status : Unknown
Verified September 2012 by Washington University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2008
Last Update Posted : September 17, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Emphysema Pulmonary Disease, Chronic Obstructive

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.


Study Design

Study Type : Observational
Actual Enrollment : 145 participants
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
Study Start Date : October 2007
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Biospecimen Retention:   Samples With DNA
Blood cells, serum, extracted RNA and DNA, lung fluid

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): NCT00757120


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Study Director: Michael Holtzman, MD Pulmonary and Critical Care, Washington University in St. Louis
Principal Investigator: Steven Brody, MD Washington University School of Medicine
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00757120     History of Changes
Other Study ID Numbers: 577
P50HL084922-01 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Keywords provided by Washington University School of Medicine:
COPD
Cigarette Smoke-Induced Inflammation
EMMPRIN
Matrix Metalloproteinase

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Emphysema
Pulmonary Emphysema
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive