Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis

NCT01718990 | Completed DMC

• 1 other identifier: PPG-IPF
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (1)

• Molecular Markers

  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.

  12 months

Study Arms (2)

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 Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IPF

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Harold Collard, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 1, 2012
• Study Start: October 1, 2012
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

US (1)