Biomarkers in Tissue Samples From Young Patients With Liver Cancer

Childhood Hepatoblastoma Clinical Trial

Official title:

Genetics and Biology of Liver Tumorigenesis in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336881
• Other study ID #: AHEP11B1
• Secondary ID: NCI-2011-02852CO
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: May 17, 2016
• Start date: April 2011

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Childhood Hepatoblastoma
• Hepatoblastoma
• Liver Neoplasms
• Stage I Childhood Liver Cancer
• Stage II Childhood Liver Cancer
• Stage III Childhood Liver Cancer
• Stage IV Childhood Liver Cancer

Intervention

Genetic:
• RNA analysis

• gene expression analysis

• microarray analysis

• nucleic acid sequencing

Other:
• diagnostic laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Children's Oncology Group	Monrovia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers associated with hepatoblastoma subtypes and cancer stages		Baseline	No
Secondary	Genes involved in embryonic development and/or stem cell signaling pathways for which preliminary data suggests involvement in the pathogenesis of hepatoblastoma		Baseline	No
Secondary	Exome sequencing		Baseline	No