Biomarkers in Tissue Samples From Young Patients With Liver Cancer

May 17, 2016 updated by: Children's Oncology Group

Genetics and Biology of Liver Tumorigenesis in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Monrovia, California, United States, 91006-3776
        • Children's Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Young patients with liver cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Correlative (tissue 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.
Genetic: gene expression analysis
Genetic: RNA analysis
Other: diagnostic laboratory biomarker analysis
Genetic: microarray analysis
Other Names:
  • gene expression profiling
Genetic: nucleic acid sequencing
Other Names:
  • Gene Sequencing
  • Molecular Biology, Nucleic Acid Sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biomarkers associated with hepatoblastoma subtypes and cancer stages
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline
Exome sequencing
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Gail Tomlinson, MD, Children's Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimate)

April 18, 2011

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHEP11B1
  • NCI-2011-02852 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • COG-AHEP11B1 (Other Identifier: Children's Oncology Group)
  • CDR0000698720 (Other Identifier: Clinical Trials.gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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