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NCT01511575 Clinical Trial

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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01511575
Other study ID # AAML12B3
Secondary ID COG-AAML12B3AAML
Status Active, not recruiting
Phase N/A
First received January 13, 2012
Last updated May 8, 2015
Start date February 2012

Study information
Verified date May 2015
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 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date
Est. primary completion date January 2100
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• RNA 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 Gene expression levels between DS AMKL and non-DS AMKL patients No
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