NCT00899002

Brief Summary

RATIONALE: Studying samples of tumor 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. PURPOSE: This laboratory study is looking at biomarkers in stored tumor samples from younger patients with liver cancer.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2007

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

April 10, 2013

Status Verified

April 1, 2013

Enrollment Period

1.8 years

First QC Date

May 9, 2009

Last Update Submit

April 8, 2013

Conditions

Liver Cancer

Keywords

childhood hepatocellular carcinomachildhood liver canceradult primary liver canceradult primary hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • Identification of proteomic profiles and molecular pathways involved in tumor progression

    Genomic analysis, targeted gene mutation analysis, immunohistochemistry, and mass spectrometry will be employed to identify proteomic profiles and specific molecular pathways involved in tumor progression of fibrolamellar carcinoma and hepatocellular carcinoma

    After collection of tissue samples

Secondary Outcomes (1)

  • Association between fibrolamellar carcinoma and hepatocellular carcinoma in terms of molecular aberrations and clinicopathologic features

    After molecular analysis of tissue and after collection of clinicopathologic data

Interventions

comparative genomic hybridizationGENETIC
Also known as: None specified
molecular genetic techniqueGENETIC
Also known as: none noted
mutation analysisGENETIC
Also known as: none noted
polymerase chain reactionGENETIC

Not noted

Also known as: none specified
proteomic profilingGENETIC
Also known as: none noted
immunohistochemistry staining methodOTHER

not noted

Also known as: none specified
laboratory biomarker analysisOTHER

not noted

Also known as: none specified
mass spectrometryOTHER

not noted

Also known as: none specified
medical chart reviewOTHER

not noted

Also known as: none specified

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Sample collection: 20 cases of fibrolamellar carcinoma and 20 hepatocellular carcinomas.

You may qualify if:

  • DISEASE CHARACTERISTICS:
  • Diagnosis of fibrolamellar carcinoma or hepatocellular carcinoma in a non-cirrhotic liver
  • Archived tumor specimens available for analysis from Vanderbilt University or Mayo Clinic

You may not qualify if:

  • Not specified
  • PATIENT CHARACTERISTICS:
  • Not specified
  • PRIOR CONCURRENT THERAPY:
  • Not specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be extracted from the tissue samples and analyzed for molecular signatures, i.e., genomic and proteomic analyses.

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

Comparative Genomic HybridizationGenetic TestingPolymerase Chain ReactionImmunohistochemistryMass Spectrometry

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Cytogenetic AnalysisGenetic TechniquesInvestigative TechniquesMolecular Diagnostic TechniquesNucleic Acid HybridizationClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health ServicesNucleic Acid Amplification TechniquesHistocytochemistryCytological TechniquesHistological TechniquesImmunologic TechniquesChemistry Techniques, Analytical

Study Officials

  • Laura Goff, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Medical Oncologist

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

July 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 10, 2013

Record last verified: 2013-04