RNA Biomarkers in Tissue Samples From Infants With Acute... | NCT01229124

Studies
RNA Biomarkers in Tissue Samples From Infants With Acute Myeloid Leukemia

NCT01229124

Sponsor

Children's Oncology Group

Status

Completed

Last Update Posted

May 17, 2016Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Leukemia

Interventions

RNA analysis
nucleic acid sequencing
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-AAML11B1	Other Identifier	Children's Oncology Group
NCI-2011-02841	Registry Identifier	CTRP (Clinical Trial Reporting Program)
AAML11B1	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

Oct 2010

Primary Completion Date

May 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Oct 26, 2010

First Submission Date that Met QC Criteria

Oct 26, 2010

First Posted Date

Oct 27, 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 13, 2016

Last Update Posted Date

May 17, 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 learn more about changes that occur in RNA and identify biomarkers related to cancer.

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

Detailed Description

OBJECTIVES:

Sequence the microRNAs present in 20 infant AML samples as a pilot study.
Compare microRNAs present in infant AML samples to infant ALL samples that are being concurrently sequenced in a separate study to identify lineage- and translocation-specific microRNAs.

OUTLINE: This is a multicenter study.

Previously collected cryopreserved cells from diagnosis are sequenced using reverse transcriptase-PCR.

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

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RNA analysis	Genetic
nucleic acid sequencing	Genetic
reverse transcriptase-polymerase chain reaction	Genetic
laboratory biomarker analysis	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sequence of the microRNAs present in 20 infant acute myeloid leukemia (AML) samples
Comparison of microRNAs present in infant AML samples to infant acute lymphoblastic leukemia samples to identify lineage- and translocation-specific microRNAs

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of acute myeloid leukemia
Available cryopreserved cells from diagnosis

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

1 Year

Standard Ages

Child

Study Population

Diagnosis of acute myeloid leukemia.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Michael Cleary, MD	Stanford University	Principal Investigator

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
D001483	Base Sequence
D020133	Reverse Transcriptase Polymerase Chain Reaction

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided