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Clinical Trials/NCT01336881
NCT01336881
Completed
Not Applicable

Genetics and Biology of Liver Tumorigenesis in Children

Children's Oncology Group1 site in 1 country99 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood Hepatoblastoma
Sponsor
Children's Oncology Group
Enrollment
99
Locations
1
Primary Endpoint
Biomarkers associated with hepatoblastoma subtypes and cancer stages
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This research trial is studying biomarkers in tissue samples from young patients with liver cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

Detailed Description

PRIMARY OBJECTIVES: I. To identify biomarker signatures associated with hepatoblastoma subtypes (by microRNA array profiling), and their potential correlation with liver developmental stages as well as outcome. II. To correlate expression array data with copy number array data. SECONDARY OBJECTIVES: I. To carry out a focused sequencing interrogation of amplified or deleted genomic regions as well as genes in key cell pathways involved in embryonic development and/or stem cell signaling pathways for which preliminary data suggests involvement in the pathogenesis of hepatoblastoma. II. To perform whole exome sequencing in a subset of tumors. OUTLINE: This is a multicenter study. Archived tumor tissue samples are analyzed for hepatoblastoma and other liver tumor biomarkers by microRNA array profiling and exome sequencing. Results are then compared with patients' clinical data.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
July 2011
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of hepatoblastoma or other liver cancer including the following subtypes:
  • Pure fetal histology
  • Transitional histology
  • Small cell undifferentiated histology
  • Participated on the Children's Oncology Group (COG) clinical trials
  • Available data and tumor samples

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Biomarkers associated with hepatoblastoma subtypes and cancer stages

Time Frame: Baseline

Secondary Outcomes

  • Genes involved in embryonic development and/or stem cell signaling pathways for which preliminary data suggests involvement in the pathogenesis of hepatoblastoma(Baseline)
  • Exome sequencing(Baseline)

Study Sites (1)

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