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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00179439
Other study ID # 2004P-000316
Secondary ID 02820-4
Status Completed
Phase N/A
First received September 12, 2005
Last updated December 11, 2017
Start date January 2004
Est. completion date January 2006

Study information

Verified date December 2017
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators hypothesize that PSC in children is associated with mutations and functional changes of the cystic fibrosis (CF) gene.


Description:

The purpose of this protocol is to perform Nasal Transepithelial Potential Difference (NTPD) testing to assess the function of the cystic fibrosis gene product, a chloride channel referred to as CFTR, in patients diagnosed with PSC and/or inflammatory bowel disease in childhood and currently 12 years of age and greater.

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- 12 years of age and older

- 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

Study Design


Intervention

Procedure:
nasal potential difference testing


Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary CFTR DNA analysis
Secondary Nasal potential difference testing
Secondary Sweat test
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