Biomarkers in Predicting Response to Chemotherapy in Samp... | NCT01374672

Studies
Biomarkers in Predicting Response to Chemotherapy in Samples From Young Patients With Osteosarcoma

NCT01374672

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 12, 2015Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Localized Osteosarcoma
Metastatic Osteosarcoma
Osteoblastic Osteosarcoma
Recurrent 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-2011-02861	Registry Identifier	CTRP (Clinical Trial Reporting Program)

Status Module

Record Verification Date

May 2015

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

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jun 15, 2011

First Submission Date that Met QC Criteria

Jun 15, 2011

First Posted Date

Jun 16, 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 8, 2015

Last Update Posted Date

May 12, 2015Estimated

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 study is studying biomarkers in predicting response to chemotherapy in samples from young patients with osteosarcoma. Studying 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 predict how patients will respond to treatment.

Detailed Description

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Children's Oncology Group Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

I. Determine whether methylation status predicts response to neoadjuvant chemotherapy in samples from children and young adults with osteosarcoma.

OUTLINE: Patients are stratified according to response to neoadjuvant chemotherapy (good vs poor).

DNA and RNA extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated PCR and mass-array genotyping.

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

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Correlative studies		DNA and RNA extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated PCR and mass-array genotyping.	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
Methylated status as predictor of response to neoadjuvant chemotherapy	Performed on a locus-by-locus basis using Poisson regression (for count data) and/or two-group t-tests, with correction (Satterwaithe's) for unequal within-group variances.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with high-grade osteoblastic osteosarcoma
Biopsy samples from patients who had good or poor response to neoadjuvant chemotherapy available
All specimens should be from post-menarchal females or age-matched males with appendicular tumors
Patients' clinical data including chemotherapy received, event-free survival, and overall survival available
See Disease Characteristics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

Diagnosed with high-grade osteoblastic osteosarcoma.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeremy Rosenblum, 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
D001859	Bone Neoplasms

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