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Emphysema Research Registry and Biosample Repository

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ClinicalTrials.gov Identifier: NCT00307281
Recruitment Status : Recruiting
First Posted : March 27, 2006
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Frank C Sciurba, University of Pittsburgh

Brief Summary:
The Comprehensive Lung Center (CLC) at the University of Pittsburgh Medical Center (UPMC Health System) provides patients with any type of breathing or lung disorder a full range of diagnostic and therapeutic services. The Emphysema/COPD Research Center (ECRC) is a specialty clinic, within this center, that attempts to advance the understanding of emphysema and to evaluate new therapies for patients with emphysema. The Emphysema Research Registry will enable pulmonary research physicians to: 1) gather information and create a research registry of people who have been diagnosed with emphysema; 2) utilize this research registry with the purpose of conducting research that attempts to advance the understanding of emphysema and to evaluate new therapies; and, 3) use the research registry to identify potential candidates for future research programs. These aims will be achieved by the collection of DNA (genetic material)for analysis and storage in addition to pulmonary function tests and other medical information.

Condition or disease
Emphysema Chronic Obstructive Pulmonary Disease Chronic Bronchitis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Emphysema Research Registry; Screening Study and Genetic Testing
Actual Study Start Date : August 2000
Estimated Primary Completion Date : July 2030
Estimated Study Completion Date : July 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Group/Cohort
Registry
10 pack year tobacco smoking history required, current or former smokers accepted.



Primary Outcome Measures :
  1. To gather information and create a research registry of people who have been diagnosed with emphysema and a control cohort of research participants without lung diseases, [ Time Frame: Indefinite ]
    This research registry will allow us to to advance the understanding of emphysema and to evaluate new therapies for patients with emphysema.


Secondary Outcome Measures :
  1. To continue communications with past, present, and future research participants. [ Time Frame: Indefinite ]
    To utilize this research registry with the purpose to learn more about the pathogenesis of emphysema and the efficacy of new therapies, and to provide a mechanism for improving the quality of treatment for emphysema and advance the field.


Biospecimen Retention:   Samples With DNA

The DNA studies that will be done as a part of this study will be restricted to/used for studies of genetics associated with COPD. Optional Alpha-1 Antitrypsin swab testing will also be performed on COPD subjects.

Specimens will assigned a study ID#



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Current and former smokers with a 10 pack year tobacco history.
Criteria

Inclusion Criteria:

  • Patients would be required to have COPD based on at least one of the following: clinical history, pulmonary function results, or radiographic results.

Exclusion Criteria:

  • none

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): NCT00307281


Contacts
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Contact: Paula Consolaro, CCRC 412-692-4800 consolaropj@upmc.edu
Contact: Elizabeth Stempkowski, BA 412-605-1904 stempkowskiem@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Emphysema/COPD Research Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact    412-692-4800    ecrc@upmc.edu   
Contact    1-866-948-COPD(2673)    ecrc@upmc.edu   
Principal Investigator: Frank C. Sciurba, MD         
Sub-Investigator: Jessica M. Bon, MD         
Sub-Investigator: Divay Chandra, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Frank C. Sciurba, MD University of Pittsburgh Medical Center
Additional Information:

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Responsible Party: Frank C Sciurba, Director, Emphysema/COPD Research Center, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00307281    
Other Study ID Numbers: UofP ERC Registry
ERC Registry ( Registry Identifier: Emphysema COPD Research Registry and Biosample Reposiory )
First Posted: March 27, 2006    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Bronchitis
Bronchitis, Chronic
Emphysema
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections