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Number of Subjects in Study Archive: 800
Study Design: Observational
Conditions: Cirrhosis, Cystic Fibrosis, Liver Diseases
Division: DDN
Duration: January 2009 – November 2018
# Recruitment Centers: 11
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Access to biospecimens for Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis Liver Disease (CFLD PUSH) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL:
http://www.clinicaltrials.gov/show/NCT01144507
Study Website: https://childrennetwork.org/Clinical-Studies
Data Package Version Number: 1 (June 11, 2020)
DOI: 10.58020/vj16-wz20
How to cite this dataset: Magee, John (2023). Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis Liver Disease (V1) [Dataset]. NIDDK Central Repository. https://doi.org/10.58020/vj16-wz20
Data availability statement: Data from the Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis Liver Disease [(V1)/https://doi.org/10.58020/vj16-wz20] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Cystic fibrosis is an inherited condition in which cell secretions are thick and sticky, instead of thin and slippery. The secretions obstruct passageways and ducts, leading to severe internal damage. Patients with cystic fibrosis sometimes develop advanced liver disease (CFLD). Hepatic cirrhosis can occur with CFLD, as a result of the inflammation and scarring caused by clogged bile ducts.
PUSH is a prospective longitudinal study that aims to determine the utility of abdominal ultrasound to predict the development of cirrhosis in patients with cystic fibrosis. Participants will undergo abdominal ultrasound at enrollment and, based on the outcome, will be placed in one of four groups. Within a five year period subjects will undergo other sample collection procedures in addition to abdominal ultrasound. This study will also monitor the effects of cystic fibrosis on associated pulmonary and nutritional issues.
The objective of the PUSH study is to determine the usefulness of abdominal ultrasound when attempting to predict the development of cirrhosis in subjects with cystic fibrosis.
Primary Outcome Measures:
During a five year period subjects will be monitored for the development of cirrhosis.
Secondary Outcome Measures:
During a five year period the effects on associated pulmonary and nutritional issues will be documented.
Inclusion Criteria:
Participants must be age 3-12 years; diagnosed with Cystic Fibrosis and pancreatic insufficiency; and be enrolled in the CFF registry study or Toronto CF Registry.
Exclusion Criteria:
Individuals will be excluded if they have cirrhosis; presence of Burkholderia cepacia; short bowel syndrome; or a serious disease that would prevent participation.
This study is ongoing, but not recruiting participants.
Specimens and Study Datasets
| Plasma | 8004 |
| Serum | 7874 |
| Urine | 7246 |
| EBV Transformed Cell Lines | 1567 |
| DNA | 979 |
| Cells | 196 |
| Lymphocytes | 194 |
| Forms |
 |
Data_Dictionary (PDF) - 342.7 KB | |
| |
Manual_of_Operations (PDF) - 3.0 MB | |
| |
Protocol (PDF) - 335.9 KB | |
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PUSH_Children_DSIC_V1 (PDF) - 710.4 KB | |
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PUSH_Children_Roadmap_V1 (PDF) - 199.4 KB |
If you need accessible versions of documents, please email your request to NIDDK-CRsupport@niddk.nih.gov.
