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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01387724
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : May 18, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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.

Condition or disease Intervention/treatment
Neuroblastoma Genetic: RNA analysis Genetic: polymerase chain reaction Genetic: protein expression analysis Genetic: proteomic profiling Genetic: western blotting Other: enzyme-linked immunosorbent assay Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry

Detailed Description:


  • 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
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neuropeptide Y and Its Receptors in Neuroblastoma
Study Start Date : June 2011
Actual Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Primary Outcome Measures :
  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

Biospecimen Retention:   Samples With DNA
blood and tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with newly diagnosed neuroblastoma or ganglioneuroblastoma.


  • 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


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01387724

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Joanna Kitlinska, PhD Lombardi Comprehensive Cancer Center

Responsible Party: Children's Oncology Group Identifier: NCT01387724     History of Changes
Other Study ID Numbers: ANBL11B1
COG-ANBL11B1 ( Other Identifier: Children's Oncology Group )
NCI-2011-02862 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ANBL11B1 ( Other Identifier: Children's Oncology Group )
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
disseminated neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma

Additional relevant MeSH terms:
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue