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NCT01358604 Clinical Trial

Biomarkers in Samples From Young Patients With Neuroblastoma

Neuroblastoma Clinical Trial

Official title:
ROR1 as a Novel Target for Neuroblastoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01358604
Other study ID # ANBL11B2
Secondary ID COG-ANBL11B2NCI-
Status Completed
Phase N/A
First received May 18, 2011
Last updated April 14, 2016
Start date May 2011
Est. completion date April 2016

Study information
Verified date April 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 120 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• polymerase chain reaction

• protein expression analysis

• western blotting

Other:
• flow cytometry

• immunohistochemistry staining method

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary ROR1 is expressed on the surface of neuroblastoma cells and constitutes a suitable target for mAb therapy No
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