Biomarkers in Tissue Samples From Young Patients With Liver Cancer

NCT01336881 | Completed

• 4 other identifiers: AHEP11B1NCI-2011-02852COG-AHEP11B1CDR0000698720
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Biomarkers associated with hepatoblastoma subtypes and cancer stages

  Baseline

Secondary Outcomes (2)

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

  Baseline

• Exome sequencing

  Baseline

Study Arms (1)

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; Genetic: nucleic acid sequencing; Other: diagnostic laboratory biomarker analysis

Interventions

RNA analysis GENETIC

Correlative (tissue analysis)

gene expression analysis GENETIC

Correlative (tissue analysis)

microarray analysis GENETIC

Also known as: gene expression profiling

Correlative (tissue analysis)

nucleic acid sequencing GENETIC

Also known as: Gene Sequencing, Molecular Biology, Nucleic Acid Sequencing

Correlative (tissue analysis)

diagnostic laboratory biomarker analysis OTHER

Correlative (tissue analysis)

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Young patients with liver cancer

You may qualify if:

• 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

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Archived tumor tissue samples

MeSH Terms

Conditions

Hepatoblastoma

Interventions

Gene Expression Profiling; Microarray Analysis; Base Sequence

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Microchip Analytical Procedures; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Genetic Structures; Genetic Phenomena

Study Officials

• Gail Tomlinson, MD

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 18, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2011
• Last Updated: May 18, 2016

Record last verified: 2016-05

Locations

US (1)