Biomarkers in Tissue Samples From Young Patients With Liv... | NCT01336881

ID	Type	Description
NCI-2011-02852	Registry Identifier	CTRP (Clinical Trial Reporting Program)
COG-AHEP11B1	Other Identifier	Children's Oncology Group
CDR0000698720	Other Identifier	Clinical Trials.gov

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Jul 2011Actual

Completion Date

Not provided

First Submitted Date

Apr 15, 2011

First Submission Date that Met QC Criteria

Apr 15, 2011

First Posted Date

Apr 18, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2016

Last Update Posted Date

May 18, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Conditions Module

Conditions

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

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

99Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
RNA analysis	Genetic		Correlative (tissue analysis)
gene expression analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Biomarkers associated with hepatoblastoma subtypes and cancer stages		Baseline

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

Young patients with liver cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gail Tomlinson, MD	Children's Oncology Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Oncology Group		Monrovia	California	91006-3776	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D018197	Hepatoblastoma

ID	Term
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D020869	Gene Expression Profiling
D046228	Microarray Analysis
D001483	Base Sequence

Ancestor Terms

ID	Term
D005821	Genetic Techniques
D008919	Investigative Techniques
D046208	Microchip Analytical Procedures
D015394	Molecular Structure
D001669	Biochemical Phenomena
D055598	Chemical Phenomena
D040342	Genetic Structures
D055614	Genetic Phenomena