IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis (PUSH)
This study is ongoing, but not recruiting participants.
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT01144507
First received: June 14, 2010
Last updated: December 17, 2015
Last verified: December 2015
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | June 14, 2010 | |||||||||
| Last Updated Date | December 17, 2015 | |||||||||
| Start Date ICMJE | January 2009 | |||||||||
| Estimated Primary Completion Date | November 2018 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Development of cirrhosis, as defined by imaging criteria [ Time Frame: Five years ] 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 five year period. |
|||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | Complete list of historical versions of study NCT01144507 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures ICMJE |
Effects on associated pulmonary and nutritional issues [ Time Frame: 5 years ]
|
|||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis | |||||||||
| Official Title ICMJE | Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis (PUSH) | |||||||||
| Brief Summary | The specific aims for this study are:
|
|||||||||
| Detailed Description | For subjects in longitudinal follow up, this study will:
|
|||||||||
| Study Type ICMJE | Observational | |||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
|||||||||
| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples With DNA Description: During this study, blood and urine specimens will be obtained, de-identified and shipped to and stored at the NIDDK repositories for use in future CFLD ancillary studies. This "biobanking" is a critical aspect of this longitudinal study to facilitate the creation of a resource of DNA and other specimens from a meaningful number of patients with CFLD. In addition, obtaining and storing DNA or EBV-transformed leukocytes (from which DNA can be extracted) will allow future studies to investigate genetic causes and influences (modifier genes) in CFLD. |
|||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | The study population will consist of males and females 3 through 12 years of age with Cystic Fibrosis and pancreatic insufficiency who are enrolled in the CFF or Toronto CF registry studies. All racial and ethnic groups will be included. | |||||||||
| Condition ICMJE |
|
|||||||||
| Intervention ICMJE |
|
|||||||||
| Study Groups/Cohorts |
|
|||||||||
| Publications * | Leung DH, Ye W, Molleston JP, Weymann A, Ling S, Paranjape SM, Romero R, Schwarzenberg SJ, Palermo J, Alonso EM, Murray KF, Marshall BC, Sherker AH, Siegel MJ, Krishnamurthy R, Harned R, Karmazyn B, Magee JC, Narkewicz MR; Cystic Fibrosis Liver Disease Network (CFLD NET). Baseline Ultrasound and Clinical Correlates in Children with Cystic Fibrosis. J Pediatr. 2015 Oct;167(4):862-868.e2. doi: 10.1016/j.jpeds.2015.06.062. Epub 2015 Aug 5. | |||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Active, not recruiting | |||||||||
| Estimated Enrollment ICMJE | 800 | |||||||||
| Estimated Completion Date | November 2018 | |||||||||
| Estimated Primary Completion Date | November 2018 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
| Sex/Gender |
|
|||||||||
| Ages | 3 Years to 12 Years (Child) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Canada, United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT01144507 | |||||||||
| Other Study ID Numbers ICMJE | CFLD PUSH | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||||||||
| Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||||||||
| Collaborators ICMJE | Cystic Fibrosis Foundation Therapeutics | |||||||||
| Investigators ICMJE |
|
|||||||||
| PRS Account | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||||||||
| Verification Date | December 2015 | |||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
||||||||||