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NCT01229956 Clinical Trial

Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:
Promoter Methylation in MLL-Rearranged Childhood AML

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01229956
Other study ID # AAML11B3
Secondary ID COG-AAML11B3NCI-
Status Completed
Phase N/A
First received October 27, 2010
Last updated May 17, 2016
Start date November 2010

Study information
Verified date May 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 18 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA methylation analysis

• gene expression analysis

• microarray analysis

• reverse transcriptase-polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of differential patterns of promoter hypermethylation and gene expression in pairwise comparisons with other cohorts and normal controls No
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