Biomarkers in Tissue Samples From Young Patients With Acu... | NCT01229956

Studies
Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia

NCT01229956

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 19, 2016Estimated

Enrollment

32Estimated

Phase

Not provided

Conditions

Leukemia

Interventions

DNA methylation analysis
gene expression analysis
microarray analysis
reverse transcriptase-polymerase chain reaction
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-AAML11B3	Other Identifier	Children's Oncology Group
NCI-2011-02842	Registry Identifier	CTRP (Clinical Trial Reporting Program)
AAML11B3	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

Nov 2010

Primary Completion Date

May 2016Actual

Completion Date

Not provided

First Submitted Date

Oct 27, 2010

First Submission Date that Met QC Criteria

Oct 27, 2010

First Posted Date

Oct 28, 2010Estimated

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 the in laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

Detailed Description

OBJECTIVES:

To determine whether the pattern of global and TSG-specific promoter CpG island hypermethylation and gene silencing that we have shown characterizes MLL-rearranged (MLL-r) infant bilineage ALL is also characteristic of other subsets of MLL-r leukemia.

OUTLINE: Previously collected cryopreserved cells from diagnosis are analyzed for promoter methylation via HELP arrays, gene expression arrays, and RT-qPCR.

PROJECTED ACCRUAL: A total of 32 samples (8 from each of 4 biologically defined cohorts) will be analyzed.

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

32Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DNA methylation analysis	Genetic
gene expression analysis	Genetic
microarray analysis	Genetic
reverse transcriptase-polymerase chain reaction	Genetic
laboratory biomarker analysis	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identification of differential patterns of promoter hypermethylation and gene expression in pairwise comparisons with other cohorts and normal controls

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Available cryopreserved cells from diagnosis
- At least 2 x 10^7 viably cryopreserved cells
One of the following biologically defined cytogenetics/molecular cohorts:
- t(9;11)
- t(11;19)
- Other 11q23 translocations
- Normal cytogenetics

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

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Patients With Acute Myeloid Leukemia.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick N. Brown, MD	CHRISTUS Santa Rosa Cancer Center at CHRISTUS Santa Rosa Hospital - City Centre	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019175	DNA Methylation
D020869	Gene Expression Profiling
D046228	Microarray Analysis
D020133	Reverse Transcriptase Polymerase Chain Reaction

Ancestor Terms

ID	Term
D008745	Methylation
D000478	Alkylation
D001669	Biochemical Phenomena
D055598	Chemical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided