Studying Protein Expression in Tissue Samples From Younge... | NCT01609803

Studies
Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma

NCT01609803

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 18, 2016Estimated

Enrollment

99Actual

Phase

Not provided

Conditions

Alveolar Childhood Rhabdomyosarcoma
Embryonal Childhood Rhabdomyosarcoma
Previously Treated Childhood Rhabdomyosarcoma
Previously Untreated Childhood Rhabdomyosarcoma
Recurrent Childhood Rhabdomyosarcoma

Interventions

laboratory biomarker analysis

Countries

United States

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

ID	Type	Description	Link
NCI-2012-01972	Registry Identifier	CTRP (Clinical Trial Reporting Program)
COG-ARST12B7	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 2012

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

May 30, 2012

First Submission Date that Met QC Criteria

May 30, 2012

First Posted Date

Jun 1, 2012Estimated

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 16, 2016

Last Update Posted Date

May 18, 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

This research trial studies protein expression in tissue samples from younger patients with rhabdomyosarcoma. 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. It may also help doctors find better ways to treat cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To investigate (in two stages) which proteins are overexpressed in association with 12q13-q14 amplification by applying fluorescence in situ hybridization (FISH) and immunohistochemical (IHC) assays to a panel of alveolar rhabdomyosarcomas (ARMS) cases organized into tissue microarrays.

OUTLINE:

Formalin-fixed paraffin-embedded tissue samples are analyzed for 12q13-q14 frequency and protein overexpression by FISH and IHC.

Conditions Module

Conditions

Alveolar Childhood Rhabdomyosarcoma
Embryonal Childhood Rhabdomyosarcoma
Previously Treated Childhood Rhabdomyosarcoma
Previously Untreated Childhood Rhabdomyosarcoma
Recurrent Childhood Rhabdomyosarcoma

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Correlative studies		Formalin-fixed paraffin-embedded tissue samples are analyzed for 12q13-q14 frequency and protein overexpression by FISH and IHC.	Other: laboratory biomarker analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laboratory biomarker analysis	Other	Correlative studies	Correlative studies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amplification and fusion status as a result of the 12q13-q14 amplification event	Fisher's exact test will be used. For a contingency table other than 2 x 2, the Freeman-Halton test (an extension of Fisher's exact test) will be applied instead.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Slides of the 2006 alveolar rhabdomyosarcoma (ARMS) TMA and the 2009 ARMS/anaplastic embryonal rhabdomyosarcoma (ERMS) TMA
- PAX3-FOXO1-positive tumors
- PAX7-FOXO1-positive tumors
- Fusion-negative tumors

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Tissue samples from younger patients with rhabdomyosarcoma from 2006

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederick Barr, MD	Children's Oncology Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Oncology Group		Monrovia	California	91006-3776	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.