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)
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Grand Rapids CF Center
🇺🇸Grand Rapids, Michigan, United States
Dartmouth Hitchcock Clinic-Lebanon
🇺🇸Lebanon, New Hampshire, United States
Women and Children's Hospital of Buffalo
🇺🇸Buffalo, New York, United States
Toledo Children's Hospital
🇺🇸Toledo, Ohio, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
The Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Nation Wide Childrens Hospital
🇺🇸Columbus, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC- University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Southwestern/Children's Medical Center of Dallas
🇺🇸Dallas, Texas, United States
West Virginia University CF Medical Center
🇺🇸Morgantown, West Virginia, United States
Phoenix Childrens Hospital
🇺🇸Phoenix, Arizona, United States
Indianapolis University
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Intermountain Cystic Fibrosis Center University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Vanderbilt Children's Hospital Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor College of Medicine/Texas Children's Hospital
🇺🇸Houston, Texas, United States
Riley Hospital for Children Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
The Children's Hospital Colarado
🇺🇸Aurora, Colorado, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Yale
🇺🇸New Haven, Connecticut, United States
The Children's Mercy Hospital--University of Missouri at Kansas City
🇺🇸Kansas City, Missouri, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Froedtert & Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States