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NCT00788359 · ClinicalTrials.gov registry record
Cystic Fibrosis Foundation (CFF) Biomarkers of Exacerbation
A clinical trial of Cystic Fibrosis, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 123
- Enrollment target
- 5
- Study locations
NCT00788359: Completed study of Cystic Fibrosis, sponsored by University of Colorado, Denver.
NCT00788359 is a study of Cystic Fibrosis that has completed, run by University of Colorado, Denver. The registered enrollment target is 123 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (31% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00788359, a study of Cystic Fibrosis, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 123 participants
- Enrollment target
- 5
- Study locations
Study Summary
Clinical and translational research in cystic fibrosis (CF) is hampered by a lack of biomarkers that can be used to identify promising new therapies. There is an urgent need for development and validation of biomarkers that more quickly predict the usefulness of potential drugs in CF and might prognosticate clinical course. In particular, combinations of protein biomarkers that can be obtained non-invasively offer great promise. The goal of this project is to determine whether protein biomarkers in blood can demonstrate a beneficial effect of treatment over two weeks. We intend to initially target an acute pulmonary exacerbation in CF because we know that subjects being treated with intravenous antibiotics and enhanced mucus clearance display clinical improvements within two weeks. We propose to prospectively collect blood samples from a large cohort of well-characterized CF persons serially during inpatient admissions for a pulmonary exacerbation and longitudinally during annual visits. Through this proposal, we hope to identify a CF lung injury biomarker panel that increases in the setting of an acute pulmonary exacerbation and improves rapidly following intravenous antibiotic therapy. Additionally, we will begin to explore whether this CF lung injury biomarker panel might also prognosticate clinical course including decline in pulmonary function. Finally, this study will serve as an important source of blood samples that will be banked for future biomarker and therapeutic studies designed to benefit the entire CF community.
Conditions Studied
Study Locations (5)
Colorado
- National Jewish Medical and Research Center - Denver
Indiana
- Riley Hospital for Children - Indianapolis
Michigan
- University of Michigan - Ann Arbor
Ohio
- Case Western Reserve University - Cleveland
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2007-12 |
| Est. Completion | 2014-07 |
What the finished NCT00788359 record still lists
NCT00788359 is an observational study that tracks outcomes without assigning an intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 0 interventions.
NCT00788359 lists 5 locations in 5 states (Colorado, Indiana, Michigan).
Frequently Asked Questions
What is clinical trial NCT00788359 about?
NCT00788359 is a clinical study titled "Cystic Fibrosis Foundation (CFF) Biomarkers of Exacerbation". Clinical and translational research in cystic fibrosis (CF) is hampered by a lack of biomarkers that can be used to identify promising new therapies. There is an urgent need for development and validation of biomarkers that more quickly predict the usefulness of potential drugs in CF and might progn...
What is the current status of trial NCT00788359?
This trial is currently completed. The enrollment target is 123 participants. The study started on 2007-12. Estimated completion is 2014-07.
What conditions does trial NCT00788359 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
Who is sponsoring clinical trial NCT00788359?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00788359 being conducted?
This trial has 5 study locations across Colorado, Indiana, Michigan, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00788359's enrollment target sits among peer trials
123 53rd of 169 higher than 117 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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