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
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
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201 Dowman Dr
Atlanta, Georgia 30303
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Chapel Hill, North Carolina 27599
(919) 962-2211
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
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Gainesville, Florida 32610
(352) 392-3261
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
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1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
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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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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
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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
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
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Baltimore, Maryland 21287
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
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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
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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2401 Gillham Road
Kansas City, Missouri 64108
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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Lexington, Kentucky
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Madison, Wisconsin 53792
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
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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
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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
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
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Toledo, Ohio 43606
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