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Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT01718990
Collaborator
(none)
110
Enrollment
1
Location
75
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 significantly speed up the process of finding drugs that help.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    110 participants
    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.
    Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Jun 30, 2018
    Actual Study Completion Date :
    Dec 31, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Molecular Markers [12 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94143

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Harold Collard, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT01718990
    Other Study ID Numbers:
    • PPG-IPF
    First Posted:
    Nov 1, 2012
    Last Update Posted:
    Jul 31, 2020
    Last Verified:
    Jul 1, 2020
    Additional relevant MeSH terms:
    Pulmonary Fibrosis
    Idiopathic Pulmonary Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Jul 31, 2020