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Completed

NCT Number: NCT01387724

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RNA analysis

Genetic

polymerase chain reaction

Genetic

protein expression analysis

Genetic

proteomic profiling

Genetic

western blotting

Genetic

enzyme-linked immunosorbent assay

Other

immunohistochemistry staining method

Other

laboratory biomarker analysis

Other

liquid chromatography

Other

mass spectrometry

Other

Primary outcomes

  1. 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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Neuropeptide Y and Its Receptors in Neuroblastoma

Important dates

Study start
2011
Primary completion
2016
First posted
Jul 4, 2011
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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