Studying Biomarker Expression in Samples From Patients With Down Syndrome and Acute Myeloid Leukemia or Other Transient Myeloproliferative Disorder

NCT ID: NCT01511575

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-05-31

Brief Summary

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RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn about changes that occur in RNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies RNA samples from patients with Down syndrome and acute myeloid leukemia or other transient myeloproliferative disorder.

Detailed Description

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OBJECTIVES:

* To compare miRNA expression in distinctive diagnostic groups: transient myeloproliferative disorder (TMD), Down syndrome (DS) acute megakaryocytic leukemia (AMkL), non-DS AMkL, and in remission DS samples (representing germline, non-malignant samples).

OUTLINE: Archived RNA samples are analyzed for mature micro (mi)RNA expression by real-time RT-PCR. Results are then compared with miRNA expression of non-Down syndrome patients with acute megakaryocytic leukemia.

Conditions

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Leukemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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RNA analysis

Intervention Type GENETIC

reverse transcriptase-polymerase chain reaction

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Patients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder
* Clinical samples obtained from patients enrolled on the COG AAML0431 and COG AAML08B1

PATIENT CHARACTERISTICS:

* Previously consented to biologic studies

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Taub, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Michigan

Other Identifiers

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COG-AAML12B3

Identifier Type: OTHER

Identifier Source: secondary_id

AAML12B3

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2012-00111

Identifier Type: REGISTRY

Identifier Source: secondary_id

AAML12B3

Identifier Type: -

Identifier Source: org_study_id

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