G551D Observational Study- Expanded to Additional Genotypes and Extended for Long Therm Follow up (GOAL-e2)
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT01521338
- Lead Sponsor
- Steven M Rowe
- Brief Summary
The goal of this research study is to collect blood and urine samples from people who have either the R117H type of CF or the non-G551D gating type of CF to be kept for future research.We will also use some of the collected blood to measure the number of neutrophils.
- Detailed Description
* Blood Collection: Blood will be collected to be kept for research in the future and to measure the number of blood cells called neutrophils. A small needle will be used to collect blood from a vein in your arm. About 7-9 teaspoons of blood would be collected.
* Sweat Collection: Your sweat will be collected with a special sweat collection machine to test the amount of salt in your sweat.
* Spirometry: You will be asked to take a test that measures how well your lungs are working. You will be asked to take a deep breath and then blow into a mouthpiece as hard as possible and for as long as possible. This is the same test that is done when you come to clinic.
* Urine Collection: Urine will also be collected to be kept for research in the future. You will be asked to pee in a cup.
* Medical Information: We are asking you to share your medical information with study researchers. Your medical information will not contain any of your personal identification information, like your name and address.
Optional:
• Induced Sputum Collection: If you say "yes" to collecting a sputum sample, you will be asked to breathe in a salt water solution to help you cough out sputum. If you cannot breathe in the salt water solution to cough out sputum for the last study visit, you will be asked to cough mucus into a cup
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint for the Core Study Change in FEV1% predicted between Visit 1 and Visit 5 Change in FEV1% predicted between Visit 1 and visit 5
- Secondary Outcome Measures
Name Time Method Change in sweat chloride between Visit 1 and Visit 5. VISIT 1 AND VISIT 5 Change in sweat chloride between Visit 1 and Visit 5.
Change in body weight between Visit 1 and Visit 5. VISIT 1 AND VISIT 5 Change in body weight between Visit 1 and Visit 5.
Trial Locations
- Locations (36)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Phoenix Childrens Hospital
🇺🇸Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
The Children's Hospital Colarado
🇺🇸Aurora, Colorado, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Yale
🇺🇸New Haven, Connecticut, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Riley Hospital for Children Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
Indianapolis University
🇺🇸Indianapolis, Indiana, United States
Scroll for more (26 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States