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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 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.

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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

Cystic Fibrosis

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

FieldValue
Enrollment Target 123 participants
Start Date 2007-12
Est. Completion 2014-07

Sponsor

University of Colorado, Denver

1,283 total trials

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What the Registry Record Tells You About NCT00788359

The ClinicalTrials.gov registry entry for NCT00788359 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 123 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (31% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 0 interventions.

NCT00788359 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.