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.|
|ClinicalTrials.gov Identifier: NCT01387724|
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : May 18, 2016
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|
- 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|
|Official Title:||Neuropeptide Y and Its Receptors in Neuroblastoma|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||May 2016|
- 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
Biospecimen Retention: Samples With DNA
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 ClinicalTrials.gov identifier (NCT number): NCT01387724
|Principal Investigator:||Joanna Kitlinska, PhD||Lombardi Comprehensive Cancer Center|