Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis (PUSH)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01144507 |
Recruitment Status
:
Active, not recruiting
First Posted
: June 15, 2010
Last Update Posted
: March 30, 2018
|
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)
Tracking Information | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date | June 14, 2010 | |||||||||
First Posted Date | June 15, 2010 | |||||||||
Last Update Posted Date | March 30, 2018 | |||||||||
Study Start Date | January 2009 | |||||||||
Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures |
Development of cirrhosis, as defined by imaging criteria [ Time Frame: Nine 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 nine year period.
|
|||||||||
Original Primary Outcome Measures |
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.
|
|||||||||
Change History | Complete list of historical versions of study NCT01144507 on ClinicalTrials.gov Archive Site | |||||||||
Current Secondary Outcome Measures |
Effects on associated pulmonary and nutritional issues [ Time Frame: 9years ]
|
|||||||||
Original Secondary Outcome Measures |
Effects on associated pulmonary and nutritional issues [ Time Frame: 5 years ]
|
|||||||||
Current Other Outcome Measures | Not Provided | |||||||||
Original Other Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title | Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis | |||||||||
Official Title | 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 | Observational | |||||||||
Study Design | 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 |
|
|||||||||
Intervention |
|
|||||||||
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 | Active, not recruiting | |||||||||
Estimated Enrollment |
800 | |||||||||
Original Estimated Enrollment |
580 | |||||||||
Estimated Study Completion Date | November 2021 | |||||||||
Estimated Primary Completion Date | November 2021 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
Sex/Gender |
|
|||||||||
Ages | 3 Years to 12 Years (Child) | |||||||||
Accepts Healthy Volunteers | No | |||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries | Canada, United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number | NCT01144507 | |||||||||
Other Study ID Numbers | CFLD PUSH U01DK062456 ( U.S. NIH Grant/Contract ) |
|||||||||
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 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||||||||
Collaborators | Cystic Fibrosis Foundation Therapeutics | |||||||||
Investigators |
|
|||||||||
PRS Account | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |||||||||
Verification Date | March 2018 |