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OpenTrials
Completed

NCT Number: NCT01336881

Biomarkers in Tissue Samples From Young Patients With Liver Cancer

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.

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Key information

Conditions

Childhood Hepatoblastoma Hepatoblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Complex and Mixed Stage I Childhood Liver Cancer Stage II Childhood Liver Cancer Stage III Childhood Liver Cancer Stage IV Childhood Liver Cancer

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Oncology Group

Monrovia, California, 91006-3776, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RNA analysis

Genetic

gene expression analysis

Genetic

microarray analysis

Genetic

Other names: gene expression profiling

nucleic acid sequencing

Genetic

Other names: Gene Sequencing, Molecular Biology, Nucleic Acid Sequencing

diagnostic laboratory biomarker analysis

Other

Primary outcomes

  1. Biomarkers associated with hepatoblastoma subtypes and cancer stages

    Time frame: Baseline

Secondary outcomes

  1. Genes involved in embryonic development and/or stem cell signaling pathways for which preliminary data suggests involvement in the pathogenesis of hepatoblastoma

    Time frame: Baseline

  2. Exome sequencing

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Genetics and Biology of Liver Tumorigenesis in Children

Important dates

Study start
2011
Primary completion
2011
First posted
Apr 18, 2011
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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