Biomarkers in Tissue Samples From Young Patients With Liver Cancer

Completed

• Conditions: Childhood Hepatoblastoma; Stage I Childhood Liver Cancer; Stage III Childhood Liver Cancer; Stage IV Childhood Liver Cancer; Stage II Childhood Liver Cancer
• Interventions: Genetic: RNA analysis; Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: nucleic acid sequencing; Other: diagnostic laboratory biomarker analysis

• Registration Number: NCT01336881
• Lead Sponsor: Children's Oncology Group

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-18
• Primary Completion: 2011-07
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Correlative (tissue analysis)	RNA analysis	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.
Correlative (tissue analysis)	microarray analysis	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.
Correlative (tissue analysis)	nucleic acid sequencing	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.
Correlative (tissue analysis)	diagnostic laboratory biomarker analysis	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.
Correlative (tissue analysis)	gene expression analysis	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.

Primary Outcome Measures

Name	Time	Method
Biomarkers associated with hepatoblastoma subtypes and cancer stages	Baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States