S8600-S9031-S9333-A, Study of DNA in Samples From Patient... | NCT01434329

Studies
S8600-S9031-S9333-A, Study of DNA in Samples From Patients With Acute Myeloid Leukemia

NCT01434329

Sponsor

SWOG Cancer Research Network

Status

Completed

Last Update Posted

Apr 15, 2016Estimated

Enrollment

200Actual

Phase

Not provided

Conditions

Leukemia

Interventions

DNA methylation analysis
gene expression analysis
microarray analysis
laboratory biomarker analysis
medical chart review

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	Link
S8600-S9031-S9333-A	Other Identifier	SWOG
U10CA032102	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 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 2011

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Sep 13, 2011

First Submission Date that Met QC Criteria

Sep 13, 2011

First Posted Date

Sep 14, 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

Apr 14, 2016

Last Update Posted Date

Apr 15, 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 blood and bone marrow 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 respond to treatment.

PURPOSE: This research trial studies DNA in samples from patients with acute myeloid leukemia.

Detailed Description

OBJECTIVES:

To identify differentially methylated regions (DMRs) associated with overall survival (OS) of acute myeloid leukemia (AML) patients with normal cytogenetics.
To develop and evaluate in an independent validation set a prognostic score for OS based on the identified DMR.
To determine whether the prognostic score can group patients into risk groups based on OS.

OUTLINE: Archived blood or bone marrow samples are analyzed for DNA methylation alterations by CHARM array-based genome assay. Each patient's clinical data is also collected.

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

200Actual

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
laboratory biomarker analysis	Other
medical chart review	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identification of DMRs associated with OS		immediate
Development and evaluation of a prognostic score of OS based on DMRs identified		immediate
Prognostic score able to group AML patients into risk groups		immediate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

De novo acute myeloid leukemia (AML) patients with normal cytogenetics treated with curative therapy who survived at least 28 days after therapy started
Samples will be taken from the following studies: SWOG-8600, SWOG-9031, SWOG-9333, SWOG-9500, SWOG-S9918, SWOG-S0106, and SWOG-S0112
- Blood or marrow specimens can be used

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients enrolled on S8600, S9031 or S9333 who consented to use of specimens for future research

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Min Fang, MD, PhD	Fred Hutchinson Cancer Center	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

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided