NCT00677183

Brief Summary

The purpose of this study is to document how often specific genotypes known to be associated with adult-onset NASH (Non-Alcoholic Steatohepatitis) occur in a pediatric cohort and investigate whether these genotypes are associated with increased susceptibility to NASH.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

8 years

First QC Date

May 9, 2008

Last Update Submit

August 21, 2015

Conditions

Non-Alcoholic Steatohepatitis

Keywords

NASHBiomarker

Outcome Measures

Primary Outcomes (2)

  • We will compare known frequencies from the Hapmap and specifically compare the proportions for those with NASH in adults to see if there is a difference in the child incidence of NASH.

    three years

  • We will compare the proportions of those with NASH to those without NASH and those with fibrosis compared to those without fibrosis.

    Three years

Study Arms (2)

SN###.#1

All children in this cohort will have biopsy-proven NASH.

SN###.#2

This cohort will be parents (mother and father when possible) of child subjects with biopsy-proven NASH.

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The child subjects will be recruited from the Hepatology Clinic at Children's Hospital of Wisconsin.

You may not qualify if:

  • other causes of chronic liver disease or other chronic diseases, specifically autoimmune disorders, immunodeficiencies, or individuals with congenital/genetic disorders
  • chronic viral hepatitis, Wilson's disease, or alpha -1- antitrypsin deficiency
  • acute life threatening illness or conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (9)

  • Angulo P, Keach JC, Batts KP, Lindor KD. Independent predictors of liver fibrosis in patients with nonalcoholic steatohepatitis. Hepatology. 1999 Dec;30(6):1356-62. doi: 10.1002/hep.510300604.

    PMID: 10573511BACKGROUND

  • Huang BE, Amos CI, Lin DY. Detecting haplotype effects in genomewide association studies. Genet Epidemiol. 2007 Dec;31(8):803-12. doi: 10.1002/gepi.20242.

    PMID: 17549762BACKGROUND

  • Benjamini, Y. and Hochberg, Y. 1995. Controlling the false discovery rate: A practical and powerful approach to multiple testing. J. Royal Stat. Soc. B (57): 289-300.

    BACKGROUND

  • Breiman L, Friedman JH, Olshen RA, Stone CJ. Classification and Regression Trees. Classification and Regression Trees. 1984.

    BACKGROUND

  • Lin DY, Zeng D, Millikan R. Maximum likelihood estimation of haplotype effects and haplotype-environment interactions in association studies. Genet Epidemiol. 2005 Dec;29(4):299-312. doi: 10.1002/gepi.20098.

    PMID: 16240443BACKGROUND

  • Iacobellis A, Marcellini M, Andriulli A, Perri F, Leandro G, Devito R, Nobili V. Non invasive evaluation of liver fibrosis in paediatric patients with nonalcoholic steatohepatitis. World J Gastroenterol. 2006 Dec 28;12(48):7821-5. doi: 10.3748/wjg.v12.i48.7821.

    PMID: 17203527BACKGROUND

  • Marra F. NASH: are genes blowing the hits? J Hepatol. 2004 May;40(5):853-6. doi: 10.1016/j.jhep.2004.03.005. No abstract available.

    PMID: 15094235BACKGROUND

  • Song J, da Costa KA, Fischer LM, Kohlmeier M, Kwock L, Wang S, Zeisel SH. Polymorphism of the PEMT gene and susceptibility to nonalcoholic fatty liver disease (NAFLD). FASEB J. 2005 Aug;19(10):1266-71. doi: 10.1096/fj.04-3580com.

    PMID: 16051693BACKGROUND

  • Marshall RJ. Partitioning methods for classification and decision making in medicine. Stat Med. 1986 Sep-Oct;5(5):517-26. doi: 10.1002/sim.4780050516.

    PMID: 3538265BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

10mL of blood will be retained from each participant and their parents. 5mL of this blood will undergo DNA extraction and genotyping for several known NASH related genes. The other 5mL of blood will be saved as serum for future analysis.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Vincent F Biank, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 14, 2008

Study Start

May 1, 2008

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations

US(1)