NCT00740337

Brief Summary

Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death in the United States. There is no cure and the disease gets worse over time. Although it usually occurs in people who smoke cigarettes, researchers do not know exactly how smoking leads to COPD. This study will compare blood and tissue samples from smokers and nonsmokers with and without COPD to determine why some COPD symptoms occur in some people and not others.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

8.3 years

First QC Date

August 20, 2008

Last Update Submit

June 15, 2018

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseCOPDEmphysemaNatural Killer T-cellInterleukin-13Innate Immune Signaling

Study Arms (2)

COPD

Participants in this group will be people who have COPD and plan to undergo lung resection surgery at Barnes-Jewish Hospital (BJH).

Control

Participants in this group will be people who do not have COPD and plan to undergo lung resection surgery at BJH.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People in this study will be invited to participate if they plan to undergo lung resection surgery at BJH.

You may qualify if:

  • Ability to read and write in English
  • Able to participate in the informed consent process
  • Planned lung resection at BJH
  • Acceptable pulmonary function tests done at BJH within 1 month of enrollment
  • Acceptable chest CT scan done at BJH within 3 years of enrollment

You may not qualify if:

  • Pregnant
  • Prisoner
  • Vulnerable populations
  • Clinically significant lung disease other than COPD and the indication for resection (e.g., cystic fibrosis, bronchiectasis, obliterative bronchiolitis, airway lesion)
  • Coexisting active chronic inflammatory or collagen vascular disease, immune deficiency of any kind, or previous organ transplant
  • Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated)
  • Systemic chemotherapy within past 1 month (30 days)
  • Hematologic malignancy or thoracic radiation within past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, isolated RNA and DNA, lung tissue

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysemaRhinitis, Allergic

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRhinitisNose DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Michael J. Holtzman, MD

    Pulmonary and Critical Care, 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

August 20, 2008

First Posted

August 22, 2008

Study Start

October 1, 2007

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

June 18, 2018

Record last verified: 2018-06

Locations