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临床试验/NCT01521338
NCT01521338已完成不适用

G551D Observational Study (GOAL)-Expanded to Additional Genotypes and Extended for Long Term Follow up (GOAL-e2)

Steven M Rowe36 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
36
主要终点
Primary Endpoint for the Core Study

研究概览

简要总结

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.

详细描述

  • 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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Primary Endpoint for the Core Study

时间窗: Change in FEV1% predicted between Visit 1 and Visit 5

Change in FEV1% predicted between Visit 1 and visit 5

次要结局

  • Change in sweat chloride between Visit 1 and Visit 5.(VISIT 1 AND VISIT 5)
  • Change in body weight between Visit 1 and Visit 5.(VISIT 1 AND VISIT 5)

研究者

发起方
Steven M Rowe
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Steven M Rowe

Principal Investigator

University of Alabama at Birmingham

研究点 (36)

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