This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Biomarkers in Tissue Samples From Young Patients With Liver Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01336881
First received: April 15, 2011
Last updated: May 17, 2016
Last verified: May 2016
  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 ]

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 ]
  • Exome sequencing [ Time Frame: Baseline ]

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   (Child)
Sexes Eligible for Study:   All
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
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gail Tomlinson, MD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01336881     History of Changes
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 )
Study First Received: April 15, 2011
Last Updated: May 17, 2016

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 August 22, 2017