Protein Expression in Human Neuroblastoma Tumor Samples | NCT01407731

Studies
Protein Expression in Human Neuroblastoma Tumor Samples

NCT01407731

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 17, 2016Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Neuroblastoma

Interventions

protein expression analysis
western blotting
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-ANBL11B4	Other Identifier	Children's Oncology Group
ANBL11B4	Other Identifier	Children's Oncology Group
NCI-2011-03799	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

May 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

Jul 2011

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Jul 30, 2011

First Submission Date that Met QC Criteria

Jul 30, 2011

First Posted Date

Aug 2, 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

May 13, 2016

Last Update Posted Date

May 17, 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 protein expression in samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat neuroblastoma.

PURPOSE: This laboratory studying is looking at protein expression in tumor tissue samples from patients with neuroblastoma.

Detailed Description

OBJECTIVES:

To determine whether intersectin (ITSN1) proteins are present at elevated levels in primary human tumor samples.

OUTLINE: Archived tumor tissue samples are analyzed for intersectin (ITSN1) expression by western blot assays with enhanced chemiluminescence and exposed to X-ray film. The films are scanned, and levels of ITSN1 signal are quantified by densitometry.

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ITSN1 is highly expressed in neuroblastoma tumors and plays an important role in the development/progression of these tumors

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosed with neuroblastoma
Banked primary tumor samples from patients with stage 1, 2, 3, and 4 disease

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

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Diagnosed with neuroblastoma.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John P. O'Bryan, PhD	University of Illinois at Chicago	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
D015153	Blotting, Western

Ancestor Terms

ID	Term
D004586	Electrophoresis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D055664	Electrochemical Techniques

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
protein expression analysis	Genetic
western blotting	Genetic
laboratory biomarker analysis	Other