CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:3/21/2019
Start Date:January 15, 2018
End Date:January 1, 2021
Contact:Anna Mead
Email:Anna.mead@seattlechildrens.org
Phone:206-884-7531

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The CHEC-SC Cohort Study: CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes

This is a multicenter, cross-sectional, cohort study which will collect contemporary SC
values from approximately 1000 CF patients prescribed and currently receiving commercially
approved CFTR modulator therapies.

Eligible subjects who have been prescribed and chronically taking a commercially approved
CFTR modulator for at least 3 months will be enrolled for a single visit to collect sweat to
be analyzed for SC at their local site laboratory. Limited clinical data obtained at this
visit will be augmented by retrospective and prospective data obtained from the CFFPR. Study
subjects who have been prescribed and switch to an alternative commercially approved CFTR
modulator will be approached to re-enroll in the study after being on the alternative
modulator for at least 3 months so that a new SC value can be obtained.

Inclusion Criteria:

- Written informed consent (and assent when applicable) obtained from subject or
subject's legal representative

- Enrolled in the CFF Patient Registry

- Male or female ≥ 4 months of age on day of study visit

- Documentation of a CF diagnosis as evidenced by one or more clinical features
consistent with the CF phenotype and one or more of the following criteria:

- Sweat chloride equal to or greater than 60 mEq/liter by quantitative pilocarpine
iontophoresis test (QPIT)

- Two well-characterized mutations in the cystic fibrosis transmembrane conductance
regulator (CFTR) gene

- Current treatment with a prescribed commercially approved CFTR modulator for at least
3 months prior to enrollment

- Able to perform the testing and procedures required for this study, as judged by the
investigator

Exclusion Criteria:

- Presence of a condition or abnormality that, in the opinion of the Investigator, would
compromise the safety of the patient or the quality of the data

- Currently enrolled in an investigational trial (including open-label follow-on studies
and EAPs) of an agent expected to have an impact on sweat chloride (refer to current
list provided on study website)
We found this trial at
51
sites
5153 North 9th Avenue
Pensacola, Florida 32504
(850) 505-4700
Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Baltimore, Maryland 21287
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Birmingham, AL
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Grand Rapids, Michigan 49503
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500 University Drive
Hershey, Pennsylvania 17033
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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2401 Gillham Road
Kansas City, Missouri 64108
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lexington, Kentucky
859) 257-9000
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Madison, Wisconsin 53792
(608) 263-2400
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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516 Delaware Street Southeast
Minneapolis, Minnesota 55455
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Morgantown, West Virginia 26506
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2200 Children's Way
Nashville, Tennessee 37232
(615) 936-1000
Vanderbilt Children's Hospital Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's...
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
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Portland, Oregon 97227
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Saint Louis, Missouri 63110
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1465 South Grand Boulevard
Saint Louis, Missouri 63104
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26 1900 East
Salt Lake City, Utah 84113
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Toledo, Ohio 43606
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