G551D Observational Study- Expanded to Additional Genotypes and Extended for Long Therm Follow up (GOAL-e2) (GOAL- e2)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||G551D Observational Study (GOAL)-Expanded to Additional Genotypes and Extended for Long Therm Follow up (GOAL-e2)|
- Primary Endpoint for the Core Study [ Time Frame: Change in FEV1% predicted between Visit 1 and Visit 5 ] [ Designated as safety issue: No ]Change in FEV1% predicted between Visit 1 and visit 5
- Change in sweat chloride between Visit 1 and Visit 5. [ Time Frame: VISIT 1 AND VISIT 5 ] [ Designated as safety issue: No ]Change in sweat chloride between Visit 1 and Visit 5.
- Change in body weight between Visit 1 and Visit 5. [ Time Frame: VISIT 1 AND VISIT 5 ] [ Designated as safety issue: No ]Change in body weight between Visit 1 and Visit 5.
- ASSOCIATION BETWEEN PRIMARY AND SECONDARY ENDPOINTS [ Time Frame: 1 YEAR ] [ Designated as safety issue: No ]The core and sub-studies will be linked so that associations between primary and secondary endpoints from each sub-study and clinical parameters (e.g., spirometry, weight, and sweat chloride) collected as part of the Core Study may be explored.
Biospecimen Retention: Samples With DNA
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
- 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.
• 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521338
|Contact: Ginger Reeves, BS, RRT, CCRCfirstname.lastname@example.org|
|Contact: Heather Hathorne, MAE, RRC, CCRCemail@example.com|
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|Principal Investigator:||Steven M Rowe, MD||University of Alabama at Birmingham|