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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
1 year–10 year
Sex eligibility
All sexes
Study type
Observational
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
polymerase chain reaction
Geneticprotein expression analysis
Geneticproteomic profiling
Geneticwestern blotting
Geneticenzyme-linked immunosorbent assay
Otherimmunohistochemistry staining method
Otherlaboratory biomarker analysis
Otherliquid chromatography
Othermass spectrometry
OtherPrimary outcomes
-
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
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
NK White Blood Cells and Interleukin in Children and Young Adults With Advanced Solid Tumors
NCT01875601
Brain Diseases, Brain Neoplasms
Bethesda, Maryland, United States
View Trial DetailsActivity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children
NCT02308527
Neoplasms, Neoplasms by Histologic Type
Vienna, Austria
View Trial DetailsA Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate in Children With Refractory or Recurrent Neuroblastoma Expressing Somatostatin Receptors.
NCT03966651
Neoplasms, Neoplasms by Histologic Type
Angers, France
View Trial DetailsN2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
NCT00253435
Neoplasms, Neoplasms by Histologic Type
Los Angeles, California, United States
View Trial Details