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Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01718990
Recruitment Status : Active, not recruiting
First Posted : November 1, 2012
Last Update Posted : May 4, 2018
Information provided by (Responsible Party):
University of California, San Francisco

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
Idiopathic Pulmonary Fibrosis (IPF)

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Study Type : Observational
Estimated Enrollment : 120 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 : October 2012
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

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.

Primary Outcome Measures :
  1. Molecular Markers [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
Serum, plasma, Bronchiolavage (BAL) supernatant, and BAL cell pellets

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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 identifier (NCT number): NCT01718990

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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Harold Collard, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco Identifier: NCT01718990     History of Changes
Other Study ID Numbers: PPG-IPF
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial