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Biomarkers in Tissue Samples From Young Patients With Liver Cancer

Genetics and Biology of Liver Tumorigenesis in Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01336881
Enrollment
99
Registered
2011-04-18
Start date
2011-04-30
Completion date
Unknown
Last updated
2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Hepatoblastoma, Stage I Childhood Liver Cancer, Stage II Childhood Liver Cancer, Stage III Childhood Liver Cancer, Stage IV Childhood Liver Cancer

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.

Interventions

GENETICRNA analysis
GENETICgene expression analysis
GENETICmicroarray analysis
GENETICnucleic acid sequencing
OTHERdiagnostic laboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Biomarkers associated with hepatoblastoma subtypes and cancer stagesBaseline

Secondary

MeasureTime frame
Genes involved in embryonic development and/or stem cell signaling pathways for which preliminary data suggests involvement in the pathogenesis of hepatoblastomaBaseline
Exome sequencingBaseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026