NCT01387724

Brief Summary

RATIONALE: Studying samples of blood and 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 blood and tissue samples from patients with newly diagnosed neuroblastoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ 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

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 4, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

4.9 years

First QC Date

July 1, 2011

Last Update Submit

May 17, 2016

Conditions

Neuroblastoma

Keywords

disseminated neuroblastomalocalized resectable neuroblastomalocalized unresectable neuroblastomaregional neuroblastomastage 4S neuroblastoma

Outcome Measures

Primary Outcomes (5)

  • Association of high expression of NPY and its Y2/Y5 Rs in NBs with poor outcome of the disease, advanced stage, increased vascularization and other unfavorable prognostic factors, such as TrkB expression and MYCN amplification

  • BDNF/TrkB and TrkAIII up-regulate expression of NPY and its Rs

  • NPY upregulates expression of the identified proteins in NB and their Rs in endothelial cells (ECs)

  • Interaction between Y2 and Y5 receptors in NB and ECs sensitize them to NPY and amplify NPY-induced proliferation

  • Blocking the NPY-Y2/Y5 pathway reduces NB growth and tumor vascularization

Interventions

RNA analysisGENETIC
polymerase chain reactionGENETIC
protein expression analysisGENETIC
proteomic profilingGENETIC
western blottingGENETIC
enzyme-linked immunosorbent assayOTHER
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER
liquid chromatographyOTHER
mass spectrometryOTHER

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with newly diagnosed neuroblastoma or ganglioneuroblastoma.

DISEASE CHARACTERISTICS: * Children with newly diagnosed neuroblastoma or ganglioneuroblastoma * Samples from the Children's Oncology Group (COG) from patients enrolled in clinical trials in institutions in the USA, Canada, and Australia * Paraffin-embedded tumor specimens, RNA isolated from tumor tissues, and patient serum must be available 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

blood and tissue

MeSH Terms

Conditions

Neuroblastoma

Interventions

Polymerase Chain ReactionBlotting, WesternEnzyme-Linked Immunosorbent AssayImmunohistochemistryChromatography, LiquidMass Spectrometry

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)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative TechniquesElectrophoresisChemistry Techniques, AnalyticalElectrochemical TechniquesImmunoblottingImmunoassayImmunologic TechniquesMolecular Probe TechniquesImmunoenzyme TechniquesImmunosorbent TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesChromatography

Study Officials

  • Joanna Kitlinska, PhD

    Lombardi Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 4, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05