Biomarkers in Tissue Samples From Young Patients With Liver Cancer

NCT ID: NCT01336881

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

RNA analysis

Intervention Type GENETIC

gene expression analysis

Intervention Type GENETIC

microarray analysis

Intervention Type GENETIC

nucleic acid sequencing

Intervention Type GENETIC

diagnostic laboratory biomarker analysis

Intervention Type OTHER

Interventions

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RNA analysis

Intervention Type GENETIC

gene expression analysis

Intervention Type GENETIC

microarray analysis

Intervention Type GENETIC

nucleic acid sequencing

Intervention Type GENETIC

diagnostic laboratory biomarker analysis

Intervention Type OTHER

Other Intervention Names

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gene expression profiling Gene Sequencing Molecular Biology, Nucleic Acid Sequencing

Eligibility Criteria

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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
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gail Tomlinson, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Children's Oncology Group

Monrovia, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2011-02852

Identifier Type: REGISTRY

Identifier Source: secondary_id

COG-AHEP11B1

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000698720

Identifier Type: OTHER

Identifier Source: secondary_id

AHEP11B1

Identifier Type: -

Identifier Source: org_study_id

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