Biomarkers in Samples From Young Patients With Soft Tissu... | NCT01342783

Studies
Biomarkers in Samples From Young Patients With Soft Tissue Sarcoma

NCT01342783

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 18, 2016Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Sarcoma

Interventions

DNA analysis
RNA analysis
mutation analysis
nucleic acid sequencing
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-ARST11B2	Other Identifier	Children's Oncology Group
NCI-2011-02853	Registry Identifier	CTRP (Clinical Trial Reporting Program)
ARST11B2	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

May 2011

Primary Completion Date

May 2016Actual

Completion Date

Not provided

First Submitted Date

Apr 23, 2011

First Submission Date that Met QC Criteria

Apr 26, 2011

First Posted Date

Apr 27, 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 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

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research trial is studying biomarkers in samples from young patients with soft tissue sarcoma.

Detailed Description

OBJECTIVES:

To identify the key components of driver pathways of primary and secondary soft tissue sarcomas.
To perform the next-generation sequencing on primary versus normal on undifferentiated sarcomas.

OUTLINE: Genomic DNA and RNA samples from undifferentiated sarcoma tumors are analyzed by next-generation sequencing for somatic mutations. Normal matched lymphocytes and tissue are also analyzed.

Conditions Module

Conditions

Sarcoma

Keywords

metastatic childhood soft tissue sarcoma
nonmetastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma
previously treated childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma

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

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DNA analysis	Genetic
RNA analysis	Genetic
mutation analysis	Genetic
nucleic acid sequencing	Genetic
laboratory biomarker analysis	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of somatic mutations in driver genes and mutations in other genes that occur individually

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Banked childhood samples from the COG-D9902 soft tissue sarcoma biology and banking study
Rhabdomyosarcoma, NOS

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

18 Years

Standard Ages

ChildAdult

Study Population

COG-D9902 soft tissue sarcoma biology and banking study participants.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Poul Sorensen, MD, PhD	British Columbia Cancer Agency	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
D001483	Base Sequence

Ancestor Terms

ID	Term
D015394	Molecular Structure
D001669	Biochemical Phenomena
D055598	Chemical Phenomena
D040342	Genetic Structures

Browse Leaves

Not provided

Browse Branches

Not provided