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NCT01144507 · ClinicalTrials.gov registry record
Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 774
- Enrollment target
NCT01144507: Completed study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01144507 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 774 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01144507 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 774 participants
- Enrollment target
Study Summary
The specific aims for this study are: 1. To determine if sonographic findings predict the risk of progression of liver disease to cirrhosis by comparing cystic fibrosis subjects with heterogeneous echogenicity pattern on ultrasound to those with normal echogenicity pattern on ultrasound 2. To develop a database and biorepository of serum, plasma, urine and DNA to aid the investigations in ascertaining the mechanisms, consequences, genetic risk factors and biomarkers for the development of cirrhosis 3. To determine if there are differences in health related quality of life, pulmonary or nutritional status in children with cystic fibrosis who have a heterogeneous echo pattern on ultrasound compared to those who have a normal echo pattern on ultrasound 4. To determine if Doppler velocity measurements of hepatic and splenic vessels predict an increased risk for the development of cirrhosis. 5. To determine if cirrhosis on ultrasound progresses to portal hypertension during the study period 6. To determine if homogeneous liver progresses to either cirrhosis or heterogeneous liver. 7. To determine the frequency of complications of portal hypertension during follow up in those identified with cirrhosis by year 6 of the study
Primary Outcome
The primary objective of this prospective longitudinal study is to determine the utility of abdominal ultrasound (US) at enrollment to predict the development of cirrhosis in subjects with cystic fibrosis (CF) within a nine year period.
Interventions
- PROCEDURE Abdominal Ultrasound
- OTHER Sample collection procedures
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 774 participants |
| Start Date | 2010-01-12 |
| Est. Completion | 2023-06-14 |
What the finished NCT01144507 record still lists
NCT01144507 is an observational study that tracks outcomes without assigning an intervention. The registered 774 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Abdominal Ultrasound is the first listed.
NCT01144507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01144507 about?
NCT01144507 is a clinical study titled "Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis". The specific aims for this study are: 1. To determine if sonographic findings predict the risk of progression of liver disease to cirrhosis by comparing cystic fibrosis subjects with heterogeneous echogenicity pattern on ultrasound to those with normal echogenicity pattern on ultrasound 2. To devel...
What is the current status of trial NCT01144507?
This trial is currently completed. The enrollment target is 774 participants. The study started on 2010-01-12. Estimated completion is 2023-06-14.
What interventions are being tested in trial NCT01144507?
The interventions under investigation include: Abdominal Ultrasound (PROCEDURE), Sample collection procedures (OTHER).
Who is sponsoring clinical trial NCT01144507?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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