Costimulatory Molecules as Biomarkers in Cystic Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01353950
First received: May 12, 2011
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

The purpose of this study is to investigate the expression of a certain class of molecules, called costimulatory molecules, in humans with Cystic Fibrosis. Cystic Fibrosis is a genetic disorder which renders the lung susceptible to persistent inflammation which, at times, can worsen, resulting in accelerated decline in lung function and eventually death or transplant. Our goal is to determine if the levels of costimulatory markers can be used to predict exacerbation and subsequent lung function decline in subjects with Cystic Fibrosis.


Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Costimulatory Molecules as Biomarkers in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Biospecimen Retention:   Samples Without DNA

Plasma, Serum, urine


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adult Cystic Fibrosis Patients
Adults with Cystic Fibrosis will be followed longitudinally for 2 years

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with Cystic Fibrosis

Criteria

Inclusion Criteria:

  • Willingness to participate

Exclusion Criteria:

  • Presence of HIV
  • Presence of Lymphoma/Leukemia
  • Presence of Lung or other solid organ Transplant
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353950

Contacts
Contact: Jeffrey A Gold, MD 5034181496 goldje@ohsu.edu

Locations
United States, Oregon
Oregon health and Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Jeffrey A GOld, MD    503-418-1496    goldje@ohsu.edu   
Principal Investigator: Jeffrey A GOld, MD         
Sponsors and Collaborators
Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Jeffrey A. Gold, MD, Oregon health and Sciences University
ClinicalTrials.gov Identifier: NCT01353950     History of Changes
Other Study ID Numbers: IRB00007132
Study First Received: May 12, 2011
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Costimulatory molecules
Cystic Fibrosis
Biomarkers

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014