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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.
 
ClinicalTrials.gov Identifier: NCT01718990
Recruitment Status : Active, not recruiting
First Posted : November 1, 2012
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date October 29, 2012
First Posted Date November 1, 2012
Last Update Posted Date May 4, 2018
Study Start Date October 2012
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 31, 2012)
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.
Original Primary Outcome Measures
 (submitted: October 29, 2012)
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 (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 IPF patients that share distinct clinical phenotypes.
Change History Complete list of historical versions of study NCT01718990 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarker Discovery for Novel Drug Development in Idiopathic Pulmonary Fibrosis
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.
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum, plasma, Bronchiolavage (BAL) supernatant, and BAL cell pellets
Sampling Method Non-Probability Sample
Study Population IPF
Condition Idiopathic Pulmonary Fibrosis (IPF)
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 29, 2012)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01718990
Other Study ID Numbers PPG-IPF
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators
Principal Investigator: Harold Collard, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2018