- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02603666
Elastography of the Liver in Cystic Fibrosis Patients. Diagnostic and Prognostic Aspects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There are 209 CF patients attending Stockholm Cystic Fibrosis Center (January 2010). All up till 15 years of age are screened for liver disease annually by ultrasound (US) and also by biochemical markers. Ultrasound is performed every third year over 15 years of age in patients without CFLD, while all of them with diagnosed CFLD are continued to be investigated annually. Biochemical markers are controlled at least once every year in all CF patients. Elastography of the liver will be planned together with the investigations of the annual follow up, in an optimal clinical status. If either US or elastography of the liver indicates liver disease or progress of the already existing pathological changes, a liver biopsy will be performed according to routine procedure at Stockholm CF Centre. Also, historical data of liver biopsies and biochemical investigations will be considered in the study.
Elastography of the liver will be performed by Fibroscan device, with transducers for children and adults, respectively.
Clinical importance Liver US investigations in CF patients have important implications but are difficult to standardize in a routine clinical setting. Elastography may have an advantage in the evaluation of early fibrosis with clinical importance in pursuing diagnostics and intensifying treatment. A significant group (up to 25 %) of CF patients may be helped by this novel method. Including histological data, accuracy of elastography in CF patients may be improved. Further details of the importance of fatty acid status in CF may be elucidated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Verified cystic fibrosis
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Elastography
Fibroscan elastography device for evaluation of liver disease in CF patients.
|
Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Elastographic Value in kPa Measured by Fibroscan
Time Frame: Within 28 days in connection with their annual evaluation at a single point of time
|
Elastographic values given in kPa by Fibroscan.
All patients undergo elastographic measurement of the liver and ultrasound of the liver.
The grade of fibrosis is to be established by setting the cut-off for cystic fibrosis patients.
|
Within 28 days in connection with their annual evaluation at a single point of time
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ferenc Karpati, MD, PhD, Stockholm CF Center, KArolinska University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/1957/31/3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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