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Biomarkers in Samples From Young Patients With Neuroblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01358604
First received: May 18, 2011
Last updated: May 26, 2011
Last verified: May 2011
History of Changes

May 18, 2011
May 26, 2011
May 2011
August 2011   (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 [ Designated as safety issue: No ]
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
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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.
 
Active, not recruiting
20
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August 2011   (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
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01358604
CDR0000700607, COG-ANBL11B2
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Gregory H. Reaman, Children's Oncology Group - Group Chair Office
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: David Hema, MD, MPH NCI - Experimental Transplantation and Immunology Branch
National Cancer Institute (NCI)
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP