Biomarkers in Blood and Tissue Samples From Patients With Newly Diagnosed Neuroblastoma

NCT ID: NCT01387724

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

* Determine the expression of neuropeptide Y (NPY) and its receptors (Rs) in human neuroblastoma (NB) tissues.
* Determine whether BDNF/TrkB and TrkAIII stimulate expression of NPY and its Rs.
* Determine whether NPY mediates BDNF- and TrkAIII-induced NB proliferation and survival.
* Determine neurotrophins' angiogenic actions.
* Identify factors released from NB cells upon NPY stimulation (proteomics).
* Determine whether NPY upregulates expression of the identified proteins in NB and their Rs in endothelial cells (ECs).
* Test whether inhibition of the identified pathways reduces angiogenic activity of NB-conditioned media.
* Determine the mechanisms of NYP actions and signaling pathways.
* Test whether blocking NPY-Y2/Y5 pathway reduces NB growth and vascularization in vivo.

OUTLINE: Archived tumor tissue and serum samples are analyzed for neuropeptide Y and its receptors (Y1, Y2, and Y5) expression, neuroblastoma prognostic factors (MYCN, TrkA, TrkAIII, TrkB, BDNF, and NGF), and angiogenic markers by real-time PCR, IHC, ELISA, radioimmunoassay (RIA), mitogenic assay, caspase 3/7 activity assay, western blots, liquid chromatography, tandem mass spectrometry, proteomic assays, and other assays. Results are then analyzed and compared with patients' clinical data, including stage of disease, its phenotype, prognostic markers, age and gender, and response to treatment.

Conditions

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Neuroblastoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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RNA analysis

Intervention Type GENETIC

polymerase chain reaction

Intervention Type GENETIC

protein expression analysis

Intervention Type GENETIC

proteomic profiling

Intervention Type GENETIC

western blotting

Intervention Type GENETIC

enzyme-linked immunosorbent assay

Intervention Type OTHER

immunohistochemistry staining method

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

liquid chromatography

Intervention Type OTHER

mass spectrometry

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanna Kitlinska, PhD

Role: PRINCIPAL_INVESTIGATOR

Lombardi Comprehensive Cancer Center

Other Identifiers

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COG-ANBL11B1

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-02862

Identifier Type: REGISTRY

Identifier Source: secondary_id

ANBL11B1

Identifier Type: OTHER

Identifier Source: secondary_id

ANBL11B1

Identifier Type: -

Identifier Source: org_study_id

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