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Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis

This study is currently recruiting participants.
Verified October 2012 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01718990
First received: October 29, 2012
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  Purpose

Unfortunately, there are no medications that have been shown to significantly change the clinical course of Idiopathic Pulmonary Fibrosis (IPF). Drug discovery can take many years especially since most studies to measure effectiveness depend on clinical outcomes like pulmonary function tests and hospitalizations.

This is an observational study designed to collect information, blood, and bronchoalveolar lavage fluid in people who have IPF and those who do not. The people who have IPF will be followed for 12 months to collect more biological samples and record clinically relevant information.

The goal of this study is to identify new molecular markers that are measurable and reliable in people who have IPF. It is hoped that these markers can be used in future drug studies to signifiacantly speed up the process of finding drugs that help.


Condition
Idiopathic Pulmonary Fibrosis (IPF)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Longitudinal Cohort Trial of Patients With Idiopathic Pulmonary Fibrosis (IPF) and Healthy Control Patients. Clinical Data, Blood, and Bronchiolavage (BAL) Fluid Will be Collected Over 12 Months.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Molecular Markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We anticipate that we will successfully enroll 60 subjects with IPF in a 12 month longitudinal cohort study and provide biological samples (Bronchiolavage (BAL), alveolar macrophages, and blood) to Projects 1-3 for use in identifying mechanistically-informative markers of alveolar epithelial cell ER stress, αvβ6-mediated TGFβ activation, and EMT. We expect that levels of some of these mechanistic markers will be measurable in patient samples, and may be differentially present in IPF compared to normal controls. Variations in baseline levels of mechanistically-informative molecular markers may identify subgroups of Idiopathic Pulmonary Fibrosis (IPF) patients that share distinct clinical phenotypes.


Biospecimen Retention:   Samples With DNA

Serum, plasma, Bronchiolavage (BAL) supernatant, and BAL cell pellets


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Idiopathic Pulmonary Fibrosis (IPF)
Sixty patients with IPF will be included in this prospective cohort;15 IPF patients per year for years 1-4.
Healthy Volunteers
Sixty normal controls will be recruited from volunteers.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

IPF

Criteria

Inclusion Criteria:

  • age 35 to 80 years
  • a diagnosis of IPF by consensus criteria

Exclusion Criteria:

  • any condition that makes the patient at unacceptable risk for bronchoscopy
  • the presence of significant co-existing emphysema on HRCT
  • active cigarette smoking (defined as smoking within the last 6 months)
  • the presence of a significant co-morbidity felt to limit life expectancy to less than 12 months.
  • active listing for lung transplantation
  • inability to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718990

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Archer Eller, MS     415-502-1958     archer.eller@ucsf.edu    
Principal Investigator: Harold Collard, MD            
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Harold Collard, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01718990     History of Changes
Other Study ID Numbers: PPG-IPF
Study First Received: October 29, 2012
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on May 16, 2013