- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01336881
Biomarkers in Tissue Samples From Young Patients With Liver Cancer
Genetics and Biology of Liver Tumorigenesis in Children
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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California
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Monrovia, California, United States, 91006-3776
- Children's Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biomarkers associated with hepatoblastoma subtypes and cancer stages
Time Frame: Baseline
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Baseline
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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
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Baseline
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Exome sequencing
Time Frame: Baseline
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gail Tomlinson, MD, Children's Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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