Biomarkers in Tissue Samples From Young Patients With Liver Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01336881
First received: April 15, 2011
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Childhood Hepatoblastoma
Stage I Childhood Liver Cancer
Stage II Childhood Liver Cancer
Stage III Childhood Liver Cancer
Stage IV Childhood Liver Cancer
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: nucleic acid sequencing
Other: diagnostic laboratory biomarker analysis

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Genetics and Biology of Liver Tumorigenesis in Children

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Biomarkers associated with hepatoblastoma subtypes and cancer stages [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Exome sequencing [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Archived tumor tissue samples


Estimated Enrollment: 99
Study Start Date: April 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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: RNA analysis Genetic: gene expression analysis Genetic: microarray analysis
Other Name: gene expression profiling
Genetic: nucleic acid sequencing
Other Names:
  • Gene Sequencing
  • Molecular Biology, Nucleic Acid Sequencing
Other: diagnostic laboratory biomarker analysis

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.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Young patients with liver cancer

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336881

Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Gail Tomlinson Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01336881     History of Changes
Other Study ID Numbers: AHEP11B1, NCI-2011-02852, COG-AHEP11B1, CDR0000698720
Study First Received: April 15, 2011
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Liver Neoplasms
Hepatoblastoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 18, 2014