Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2004-01-31
2006-01-31
Brief Summary
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Detailed Description
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Dr. Freedman's laboratory has shown that there is an increased prevalence of CFTR abnormalities in adults with PSC as demonstrated by genotype and phenotype analysis. We hypothesize that abnormalities in CFTR based on exhaustive genotype and phenotype assessments are associated with the presence of PSC in children. We would like to enroll patients with inflammatory bowel disease and no PSC to use as a "control group".
Subjects with PSC and/or inflammatory bowel disease diagnosed in childhood, currently aged 12 years and above, will be enrolled in study protocols at Children's Hospital in Boston, which will have received their local IRB approval. The only role for BIDMC will be to perform NTPD testing on these subjects. No other assessment or testing will be performed at our site. We will not be involved in any other aspect of care for these subjects.
Conditions
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Keywords
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Interventions
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nasal potential difference testing
Eligibility Criteria
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Inclusion Criteria
* Must have diagnosis of primary sclerosing cholangitis and/or inflammatory bowel disease
* Absence of other liver disease, such as viral hepatitis, drug-induced liver disease, and metabolic/hereditary liver disease
* No exclusion based on sex, race, and ethnic background
12 Years
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Steven Freedman
MD PhD Full Professor Harvard Medical School
Principal Investigators
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Harpreet Pall, MD
Role: STUDY_DIRECTOR
Boston Children's Hospital
Steven D Freedman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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02820-4
Identifier Type: -
Identifier Source: secondary_id
2004P-000316
Identifier Type: -
Identifier Source: org_study_id