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

May 17, 2016 updated by: Children's Oncology Group

Neuropeptide Y and Its Receptors in Neuroblastoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with newly diagnosed neuroblastoma or ganglioneuroblastoma.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Joanna Kitlinska, PhD, Lombardi Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

July 1, 2011

First Submitted That Met QC Criteria

July 1, 2011

First Posted (ESTIMATE)

July 4, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANBL11B1 (OTHER: Children's Oncology Group)
  • COG-ANBL11B1 (OTHER: Children's Oncology Group)
  • NCI-2011-02862 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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