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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
  Purpose

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.


Condition Intervention
Neuroblastoma Genetic: polymerase chain reaction Genetic: protein expression analysis Genetic: western blotting Other: flow cytometry Other: immunohistochemistry staining method Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: ROR1 as a Novel Target for Neuroblastoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • ROR1 is expressed on the surface of neuroblastoma cells and constitutes a suitable target for mAb therapy

Enrollment: 20
Study Start Date: May 2011
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with neuroblastoma.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01358604


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: David Hema, MD, MPH NCI - Experimental Transplantation and Immunology Branch
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01358604     History of Changes
Other Study ID Numbers: 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 )
First Submitted: May 18, 2011
First Posted: May 23, 2011
Last Update Posted: April 15, 2016
Last Verified: April 2016

Keywords provided by Children's Oncology Group:
localized resectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
localized unresectable 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