NCT01493830

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 research trial studies biomarkers in tumor samples from younger patients with neuroblastoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Status
completed

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

December 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

4.6 years

First QC Date

December 15, 2011

Last Update Submit

July 7, 2016

Conditions

Neuroblastoma

Keywords

neuroblastoma

Outcome Measures

Primary Outcomes (3)

  • Expression of UBE4B, hrs, and members of the ubiquitination protein complex

  • Expression levels and cellular localization of the UBE4B, hrs, and growth factor receptors

  • 1p36 deletion status and its association with UBE4B

Interventions

fluorescence in situ hybridizationGENETIC
gene expression analysisGENETIC
microarray analysisGENETIC
mutation analysisGENETIC
protein analysisGENETIC
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER
microscopyOTHER

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients With Neuroblastoma

DISEASE CHARACTERISTICS: * Tumor tissue microarrays from the Children's Oncology Group neuroblastoma tumor bank PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Tumor samples

MeSH Terms

Conditions

Neuroblastoma

Interventions

In Situ Hybridization, FluorescenceGene Expression ProfilingMicroarray AnalysisImmunohistochemistryMicroscopy

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

In Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationMicrochip Analytical ProceduresHistocytochemistryImmunologic TechniquesDiagnostic Imaging

Study Officials

  • Peter Zage, MD, PhD

    Texas Children's Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 16, 2011

Study Start

December 1, 2011

Primary Completion

July 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07