Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis
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|ClinicalTrials.gov Identifier: NCT01718990|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2012
Last Update Posted : May 4, 2018
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)|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|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.
Sixty normal controls will be recruited from volunteers.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01718990
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Harold Collard, MD||University of California, San Francisco|