Genetic Biomarkers in Tissue Samples From Patients With O... | NCT01807143

Studies
Genetic Biomarkers in Tissue Samples From Patients With Osteosarcoma

NCT01807143

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

Mar 8, 2016Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Osteosarcoma

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

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	Link
NCI-2013-00124	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

Mar 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

Jan 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Not provided

First Submitted Date

Mar 6, 2013

First Submission Date that Met QC Criteria

Mar 6, 2013

First Posted Date

Mar 8, 2013Estimated

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

Mar 4, 2016

Last Update Posted Date

Mar 8, 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 clinical trial studies genetic biomarkers in tissue samples from patients with osteosarcoma. 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

Detailed Description

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Samples from the COG Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

I. To use PET sequencing to analyze DNA from ten human primary osteosarcoma samples, along with matched normal tissue where available.

OUTLINE:

Tissue samples are analyzed for translocations and deletions and analyzed using polymerase chain reaction (PCR) or fluorescence in situ hybridization (FISH).

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

Retention

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Correlative studies		Tissue samples are analyzed for translocations and deletions and analyzed using PCR or FISH.	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
Mapping and filtering of paired tags	Mapping of paired tags to reference genomes to identify aberrant pairs, caused by translocations, insertions, deletions and inversions.	Up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Samples from the COG tissue repository

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

Osteosarcoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Gorlick, 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

Condition Browse Module

MeSH Terms

ID	Term
D012516	Osteosarcoma

Ancestor Terms

ID	Term
D018213	Neoplasms, Bone Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided