Biomarkers in Samples From Young Patients With Neuroblastoma | NCT01358604

Studies
Biomarkers in Samples From Young Patients With Neuroblastoma

NCT01358604

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

Apr 15, 2016Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Neuroblastoma

Interventions

polymerase chain reaction
protein expression analysis
western blotting
flow cytometry
immunohistochemistry staining method
laboratory biomarker analysis

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
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

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

May 18, 2011

First Submission Date that Met QC Criteria

May 18, 2011

First Posted Date

May 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2016

Last Update Posted Date

Apr 15, 2016Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
polymerase chain reaction	Genetic
protein expression analysis	Genetic
western blotting	Genetic
flow cytometry	Other
immunohistochemistry staining method	Other
laboratory biomarker analysis	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ROR1 is expressed on the surface of neuroblastoma cells and constitutes a suitable target for mAb therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

120 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients diagnosed with neuroblastoma.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Hema, MD, MPH	NCI - Experimental Transplantation and Immunology Branch	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009447	Neuroblastoma

Ancestor Terms

ID	Term
D018241	Neuroectodermal Tumors, Primitive, Peripheral
D018242	Neuroectodermal Tumors, Primitive
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016133	Polymerase Chain Reaction
D015153	Blotting, Western
D005434	Flow Cytometry
D007150	Immunohistochemistry

Ancestor Terms

ID	Term
D021141	Nucleic Acid Amplification Techniques
D005821	Genetic Techniques
D008919	Investigative Techniques
D004586	Electrophoresis

Browse Leaves

Not provided

Browse Branches

Not provided