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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 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.

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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

Interventions

  • PROCEDURE Abdominal Ultrasound
  • OTHER Sample collection procedures

Trial Details

FieldValue
Enrollment Target 774 participants
Start Date 2010-01-12
Est. Completion 2023-06-14

What the Registry Record Tells You About NCT01144507

The ClinicalTrials.gov registry entry for NCT01144507 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 774 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Abdominal Ultrasound is the first listed.

NCT01144507 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.