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NCT02477319 · ClinicalTrials.gov registry record
A Two-Part Multicenter Prospective Longitudinal Study of CFTR-dependent Disease Profiling in Cystic Fibrosis (PROSPECT)
A clinical trial of Cystic Fibrosis, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- 452
- Enrollment target
- 20
- Study locations
NCT02477319: Completed study of Cystic Fibrosis, sponsored by University of Alabama at Birmingham.
NCT02477319 is a study of Cystic Fibrosis that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 452 participants, above the 177-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (155% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02477319, a study of Cystic Fibrosis, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- 452 participants
- Enrollment target
- 20
- Study locations
Study Summary
identify and validate biomarkers that might reflect partial restoration of CFTR function and can be used to monitor disease progression, and ii) evaluate the mechanistic effects of CFTR modulators and other relevant therapies in individuals with CF
Primary Outcome
This is the primary endpoint for Part A per the PROSPECT protocol. Mean sweat chloride was not reported for Part B, as it is not a relevant statistic. For cohort 1, sweat chloride is from day 0 only. For cohorts 2-3, sweat chloride was averaged from days 0, 14, 90 via a random intercept longitudinal model.
Conditions Studied
Interventions
- OTHER Observational
Study Locations (20)
Missouri
- Children's Mercy Hospital - Kansas City
- Cardinal Glennon Children's Medical Center - St Louis
- St. Louis Children's Hospital - St Louis
California
- Childrens Hospital Los Angeles - Los Angeles
- Lucile S. Packard Children's Hospital - Palo Alto
Colorado
- The Children's Hospital Colarado - Aurora
- National Jewish Health - Denver
Massachusetts
- Massachusetts General Hospital - Boston
- Children's Hospital Boston - Boston
Michigan
- Children's Hospital of Michigan - Detroit
- Devon Children's Hospital at Spectrum Health - Grand Rapids
New York
- Women and Children's Hospital of Buffalo - Buffalo
- Columbia University Medical Center - New York
Alabama
- University of Alabama at Birmingham - Birmingham
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 452 participants |
| Start Date | 2015-03 |
| Est. Completion | 2018-07-27 |
What the finished NCT02477319 record still lists
NCT02477319 is an observational study that tracks outcomes without assigning an intervention. The registered 452 participants enrollment target is mid-sized for trials with a published cap, above the 177-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (155% higher).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Observational is the first listed.
NCT02477319 names 20 study sites across 13 states, led by Missouri, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT02477319 about?
NCT02477319 is a clinical study titled "A Two-Part Multicenter Prospective Longitudinal Study of CFTR-dependent Disease Profiling in Cystic Fibrosis (PROSPECT)". identify and validate biomarkers that might reflect partial restoration of CFTR function and can be used to monitor disease progression, and ii) evaluate the mechanistic effects of CFTR modulators and other relevant therapies in individuals with CF
What is the current status of trial NCT02477319?
This trial is currently completed. The enrollment target is 452 participants. The study started on 2015-03. Estimated completion is 2018-07-27.
What conditions does trial NCT02477319 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT02477319?
The interventions under investigation include: Observational (OTHER).
Who is sponsoring clinical trial NCT02477319?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02477319 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Illinois, Indiana. 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 NCT02477319's enrollment target sits among peer trials
452 14th of 169 higher than 156 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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