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Study Name: GOAL-e2 Expansion Study
Study Type: Observational
Intervention Category: Not Applicable
Study Sponsor: Rowe, Steven

Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Study Phase: Other
Recruitment Status: Recruiting
Study Drug(s): Not Applicable
Number of Participants Being Recruited: 90
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this study is to collect samples from people who have either the R117H or other non-G551D gating CFTR mutations to be kept for future research. Samples of blood, sputum, and urine may be collected for this study along with pulmonary function testing.
ELIGIBILITY
Age: >= 6 Years
FEV1: >= Percent Predicted
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Must have following CFTR mutations:
For Cohort 2:
a) R117H on at least 1 allele
b) Any known or unknown mutation on the second allele except G551D

For Cohort 3:
a) A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, G1349D)
b) Any known or unknown mutation on the second allele except G551D OR R117H

Cannot be participating in the VX-770-105, VX-770-106, VX-770-108, VX-770-110, VX-770-111, VX-770-112, or VX-770-113 study, VX-770 Extended Access Program or use of ivacaftor within 6 months prior to Visit 1.
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information: Sagel, Scott
(720) 777-5546
scott.sagel@childrenscolorado.org
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01521338
Clinical Research Terms Glossary: Click here
PARTICIPATING SITES:
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
AL
  • The Children's Hospital/University of Alabama at Birmingham (Pediatric), Birmingham, AL, 35233
    Contact Information:
        Hathorne, Heather
        Phone: (205) 638-9568
        Email: hhathorne@peds.uab.edu
CA
  • Stanford University Medical Center (Pediatric), Palo Alto, CA, 94304
    Contact Information:
        Dunn, Colleen
        Phone: (650) 736-0388
        Email: cedunn@stanford.edu
CO
  • Children's Hospital Colorado (Pediatric), Aurora, CO, 80045
    Contact Information:
        Pardee, Churee
        Phone: (720) 777-6162
        Email: churee.pardee@childrenscolorado.org
  • National Jewish Health (Adult), Denver, CO, 80206
    Contact Information:
        Jones, Marion
        Phone: (303) 398-1265
        Email: jonesm@njhealth.org
CT
  • Yale University School of Medicine (Pediatric), New Haven, CT, 06520
    Contact Information:
        Young, Jane
        Phone: (203) 785-5852
        Email: jane.young@yale.edu
IL
  • University of Chicago (Adult), Chicago, IL, 60637
    Contact Information:
        Holland, Spring
        Phone: (773) 834-4053
        Email: sholland@medicine.bsd.uchicago.edu
IN
  • Riley Hospital for Children Indiana University Medical Center (Pediatric), Indianapolis, IN, 46202
    Contact Information:
        Bendy, Lisa
        Phone: (317) 948-7152
        Email: lbendy@iupui.edu
MA
  • Children's Hospital Boston (Pediatric), Boston, MA, 02115
    Contact Information:
        Fowler, Robert
        Phone: (617) 355-1834
        Email: Robert.fowler@childrens.harvard.edu
  • Massachusetts General Hospital (Pediatric), Boston, MA, 02114
    Contact Information:
        Doolittle, Caitlin
        Phone: (617) 726-3719
        Email: cdoolittle1@partners.org
MD
  • Johns Hopkins University (Pediatric), Baltimore, MD, 21287
    Contact Information:
        Callahan, Karen
        Phone: (443) 287-8983
        Email: kcallah1@jhmi.edu
MI
  • Children's Hospital of Michigan (Pediatric), Detroit, MI, 48201
    Contact Information:
        Van Wagnen, Catherine
        Phone: (313) 745-4737
        Email: cvanwag@med.wayne.edu
  • Helen DeVos Women and Children's Center (Pediatric), Grand Rapids, MI, 49503
    Contact Information:
        Gile, Cynthia
        Phone: (616) 391-6148
        Email: Cynthia.Gile@spectrumhealth.org
MN
  • The Minnesota Cystic Fibrosis Center (Pediatric), Minneapolis, MN, 55455
    Contact Information:
        Grover, Patricia
        Phone: (612) 626-7425
        Email: Grove026@umn.edu
MO
  • The Children's Mercy Hospital (Pediatric and Adult), Kansas City, MO, 64108
    Contact Information:
        Schmoll, Candy
        Phone: (816) 701-1339
        Email: cschmoll@cmh.edu
NC
  • University of North Carolina at Chapel Hill (Pediatric), Chapel Hill, NC, 27599
    Contact Information:
        Barlow, Carol
        Phone: (919) 966-9146
        Email: cbarlow@med.unc.edu
NH
  • Dartmouth Hitchcock Medical Center (Pediatric), Lebanon, NH, 03756
    Contact Information:
        Moulton, Lisa
        Phone: (603) 650-8178
        Email: Lisa.A.Moulton@Hitchcock.ORG
NY
  • Women and Children's Hospital of Buffalo (Pediatric), Buffalo, NY, 14222
    Contact Information:
        Caci, Nadine
        Phone: (716) 878-7524
        Email: ncaci@upa.chob.edu
OH
  • Cincinnati Children's Hospital Medical Center (Pediatric), Cincinnati, OH, 45229
    Contact Information:
        Duan, Lorrie
        Phone: (513) 636-7089
        Email: lorrie.duan@cchmc.org
  • University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital (Pediatric), Cleveland, OH, 44106
    Contact Information:
        Ksenich, Roberta (Bobbi)
        Phone: (216) 844-5733
        Email: Roberta.Ksenich@UHHospitals.org
  • Nationwide Children's Hospital (Pediatric), Columbus, OH, 43205
    Contact Information:
        Gilmore, Diana
        Phone: (614) 722-4752
        Email: Diana.Gilmore@nationwidechildrens.org
  • Toldeo Children's Hospital (Pediatric), Toledo, OH, 43606
    Contact Information:
        Houser, Kelly
        Phone: (419) 291-4630
        Email: kelly.houser@promedica.org
OR
  • Oregon Health Sciences University (Pediatric), Portland, OR, 97201
    Contact Information:
        Simmons, Kim
        Phone: (503) 494-7807
        Email: simmonsk@ohsu.edu
PA
  • Children's Hospital of Philadelphia University of Pennsylvania (Pediatric), Philadelphia, PA, 19104
    Contact Information:
        Kubrak, Christina
        Phone: (267) 426-5135
        Email: kubrak@email.chop.edu
  • Children's Hospital of Pittsburgh of UPMC (Pediatric), Pittsburgh, PA, 15213
    Contact Information:
        Hartigan, Elizabeth
        Phone: (412) 692-7060
        Email: elizabeth.hartigan@chp.edu
SC
  • Medical University of South Carolina (Pediatric), Charleston, SC, 29403
    Contact Information:
        Warden, Ashley
        Phone: (843) 792-4349
        Email: jonesash@musc.edu
TN
  • Vanderbilt Children's Hospital Vanderbilt University Medical Center (Pediatric), Nashville, TN, 37232
    Contact Information:
        Berry, Pamela
        Phone: (615) 936-8308
        Email: pamela.berry@Vanderbilt.Edu
TX
  • University of Texas Southwestern Medical Center/ St. Paul University Hospital (Adult), Dallas, TX, 75390
    Contact Information:
        Keller, Ashley
        Phone: (214) 648-2817
        Email: Ashley.Keller@UTSouthwestern.edu
  • Baylor College of Medicine (Pediatric), Houston, TX, 77030
    Contact Information:
        Schaap, Nicoline
        Phone: (832) 822-4252
        Email: nxschaap@texaschildrens.org
UT
  • Intermountain Cystic Fibrosis Center (Adult), Salt Lake City, UT, 84132
    Contact Information:
        Packer, Kristyn
        Phone: (801) 585-0401
        Email: kristyn.packer@hsc.utah.edu
WI
  • Froedtert & Medical College of Wisconsin (Adult), Milwaukee, WI, 53201
    Contact Information:
        Harris, Rachel
        Phone: (414) 955-7030
        Email: racharris@mcw.edu
WV
  • West Virginia University CF Center (Pediatric and Adult), Morgantown, WV, 26505
    Contact Information:
        Collins, Sue
        Phone: (304) 293-7348
        Email: scollins@hsc.wvu.edu
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