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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01387724
First received: July 1, 2011
Last updated: July 7, 2011
Last verified: June 2011
  Purpose

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 Intervention
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

Study Type: Observational
Official Title: Neuropeptide Y and Its Receptors in Neuroblastoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • BDNF/TrkB and TrkAIII up-regulate expression of NPY and its Rs [ Designated as safety issue: No ]
  • NPY upregulates expression of the identified proteins in NB and their Rs in endothelial cells (ECs) [ Designated as safety issue: No ]
  • Interaction between Y2 and Y5 receptors in NB and ECs sensitize them to NPY and amplify NPY-induced proliferation [ Designated as safety issue: No ]
  • Blocking the NPY-Y2/Y5 pathway reduces NB growth and tumor vascularization [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387724

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Joanna Kitlinska, PhD Lombardi Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01387724     History of Changes
Other Study ID Numbers: CDR0000703005, COG-ANBL11B1
Study First Received: July 1, 2011
Last Updated: July 7, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
disseminated neuroblastoma
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma

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

ClinicalTrials.gov processed this record on October 16, 2014