Biomarker in Tumor Tissue Samples From Patients With Rhab... | NCT01365962

Studies
Biomarker in Tumor Tissue Samples From Patients With Rhabdomyosarcoma

NCT01365962

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 19, 2016Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Sarcoma

Interventions

gene expression analysis
immunohistochemistry staining method
laboratory biomarker analysis
mass spectrometry

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-ARST11B4	Other Identifier	Children's Oncology Group
NCI-2011-02858	Registry Identifier	CTRP (Clinical Trial Reporting Program)
ARST11B4	Other Identifier	Children's Oncology Group

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

Jun 2011

Primary Completion Date

May 2016Actual

Completion Date

Not provided

First Submitted Date

Jun 1, 2011

First Submission Date that Met QC Criteria

Jun 1, 2011

First Posted Date

Jun 3, 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 17, 2016

Last Update Posted Date

May 19, 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 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 trial studies biomarkers in tumor tissue samples from patients with rhabdomyosarcoma.

Detailed Description

OBJECTIVES:

To determine and quantify the degree of surface insulin-like growth factor I receptor (IGF-IR) expression in rhabdomyosarcoma (RMS) tumor tissue.
To assess the feasibility and validity of a mass spectrometry assay for IGF-IR expression on paraffin-embedded tumor tissue.

OUTLINE: Paraffin-embedded tumor tissue slides are analyzed for insulin-like growth factor I receptor (IGF-1R) expression by mass spectrometry and correlated with the results obtained by IHC assay.

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

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gene expression analysis	Genetic
immunohistochemistry staining method	Other
laboratory biomarker analysis	Other
mass spectrometry	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of surface IGF-IR expression in RMS tumor tissue
Feasibility and validity of a mass spectrometry assay for IGF-IR expression on paraffin-embedded tumor tissue

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of rhabdomyosarcoma
- Alveolar or embryonal rhabdomyosarcoma
Available samples from the Cooperative Human Tissue Network (CHTN) bank

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

Diagnosis of rhabdomyosarcoma.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suman Malempati, MD	Doernbecher Children's Hospital at Oregon Health and Science University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012509	Sarcoma

Ancestor Terms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020869	Gene Expression Profiling
D007150	Immunohistochemistry
D013058	Mass Spectrometry

Ancestor Terms

ID	Term
D005821	Genetic Techniques
D008919	Investigative Techniques
D006651	Histocytochemistry
D003584	Cytological Techniques

Browse Leaves

Not provided

Browse Branches

Not provided