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

May 13, 2016 updated by: Children's Oncology Group

Analysis of MicroRNA Expression in Down Syndrome Acute Myeloid Leukemia and the Transient Myeloproliferative Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Gene expression levels between DS AMKL and non-DS AMKL patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

January 13, 2012

First Submitted That Met QC Criteria

January 13, 2012

First Posted (ESTIMATE)

January 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 17, 2016

Last Update Submitted That Met QC Criteria

May 13, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAML12B3 (OTHER: Children's Oncology Group)
  • COG-AAML12B3 (OTHER: Children's Oncology Group)
  • NCI-2012-00111 (REGISTRY: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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