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Biomarkers in Samples From Young Patients With Neuroblastoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01358604
First Posted: May 23, 2011
Last Update Posted: April 15, 2016
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
May 18, 2011
May 23, 2011
April 15, 2016
May 2011
April 2016   (Final data collection date for primary outcome measure)
ROR1 is expressed on the surface of neuroblastoma cells and constitutes a suitable target for mAb therapy
Same as current
Complete list of historical versions of study NCT01358604 on ClinicalTrials.gov Archive Site
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Biomarkers in Samples From Young Patients With Neuroblastoma
ROR1 as a Novel Target for Neuroblastoma

RATIONALE: Studying samples of tissue and bone marrow 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 study studies biomarkers in samples from young patients with neuroblastoma.

OBJECTIVES:

Primary

  • To analyze the expression of ROR1 on the surface of primary neuroblastoma cells.
  • To investigate the therapeutic potential of anti-ROR1 monoclonal antibodies (mAbs), bispecific antibodies, and immunotoxins in in vitro and in vivo models of neuroblastoma.

OUTLINE: Archived bone marrow and tumor tissue samples are analyzed for ROR1 expression by flow cytometry, western blotting, qPCR, and IHC.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample
Patients diagnosed with neuroblastoma.
Neuroblastoma
  • Genetic: polymerase chain reaction
  • Genetic: protein expression analysis
  • Genetic: western blotting
  • Other: flow cytometry
  • Other: immunohistochemistry staining method
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2016
April 2016   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosed with neuroblastoma

    • With or without N-myc amplification
  • Primary tumor samples as frozen tissue in liquid nitrogen or -80 degrees C
  • Bone marrow samples from high-risk patients as peripheral blood mononuclear cells (PBMC) that have been cryopreserved with DMSO as viable cells to be used for flow cytometry or slides of bone marrow that can be used for immunohistochemistry

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Sexes Eligible for Study: All
up to 120 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01358604
ANBL11B2
COG-ANBL11B2 ( Other Identifier: Children's Oncology Group )
NCI-2011-02855 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ANBL11B2 ( Other Identifier: Children's Oncology Group )
No
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Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: David Hema, MD, MPH NCI - Experimental Transplantation and Immunology Branch
Children's Oncology Group
April 2016