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Report for Clinical Trial NCT01521338

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT01521338 Cystic Fibrosis
MeSH: Cystic Fibrosis Fibrosis


Primary Outcomes

Description: Change in FEV1% predicted between Visit 1 and visit 5

Measure: Primary Endpoint for the Core Study

Time: Change in FEV1% predicted between Visit 1 and Visit 5

Secondary Outcomes

Description: Change in sweat chloride between Visit 1 and Visit 5.

Measure: Change in sweat chloride between Visit 1 and Visit 5.

Time: VISIT 1 AND VISIT 5

Description: Change in body weight between Visit 1 and Visit 5.

Measure: Change in body weight between Visit 1 and Visit 5.

Time: VISIT 1 AND VISIT 5

Other Outcomes

Description: 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.

Measure: ASSOCIATION BETWEEN PRIMARY AND SECONDARY ENDPOINTS

Time: 1 YEAR

Time Perspective: Prospective

Cohort


There are 10 SNPs

SNPs


1 G1244E

For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). --- G551D --- --- G178R --- --- S549N --- --- S549R --- --- G970R --- --- G1244E ---


2 G1349D

For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). --- G551D --- --- G178R --- --- S549N --- --- S549R --- --- G970R --- --- G1244E --- --- S1251N --- --- S1255P --- --- G1349D ---


3 G178R

For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). --- G551D --- --- G178R ---


4 G551D

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

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

G551D Observational Study- Expanded to Additional Genotypes and Extended for Long Therm Follow up (GOAL-e2) 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. --- G551D --- --- R117H --- --- G551D ---

For Cohort 1 (Closed to enrollment June 30, 2012): G551D on at least 1 allele Any known or unknown mutations allowed on second allele. --- G551D ---

2. For Cohort 2: R117H on at least 1 allele Any known or unknown mutation on the second allele except G551D 3. --- R117H --- --- G551D ---

For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). --- G551D ---

For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). --- G551D --- --- G178R --- --- S549N --- --- S549R --- --- G970R --- --- G1244E --- --- S1251N --- --- S1255P --- --- G1349D --- --- G551D ---


5 G970R

For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). --- G551D --- --- G178R --- --- S549N --- --- S549R --- --- G970R ---


6 R117H

G551D Observational Study- Expanded to Additional Genotypes and Extended for Long Therm Follow up (GOAL-e2) 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. --- G551D --- --- R117H ---

2. For Cohort 2: R117H on at least 1 allele Any known or unknown mutation on the second allele except G551D 3. --- R117H ---

For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). --- G551D --- --- G178R --- --- S549N --- --- S549R --- --- G970R --- --- G1244E --- --- S1251N --- --- S1255P --- --- G1349D --- --- G551D --- --- R117H ---


7 S1251N

For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). --- G551D --- --- G178R --- --- S549N --- --- S549R --- --- G970R --- --- G1244E --- --- S1251N ---


8 S1255P

For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). --- G551D --- --- G178R --- --- S549N --- --- S549R --- --- G970R --- --- G1244E --- --- S1251N --- --- S1255P ---


9 S549N

For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). --- G551D --- --- G178R --- --- S549N ---


10 S549R

For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). --- G551D --- --- G178R --- --- S549N --- --- S549R ---



HPO Nodes