Biomarkers in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:

Pediatric Myeloid Leukemia-Specific miRNA Expression Profiles Induced by the Leukemic Stem Cell Niche

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298414
• Other study ID #: AAML11B9
• Secondary ID: COG-AAML11B9NCI-
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: May 17, 2016
• Start date: February 2011
• Est. completion date: May 2016

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 bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers in bone marrow samples from young patients with acute myeloid leukemia.

Description:

OBJECTIVES:

• To study the effect of niche mesenchymal stromal cells (MSC) exposure on microRNAs (miR) expression in pediatric AML at different time points and compare those profiles to the miR profiles at baseline.

• To focus on four pediatric AML-specific miRs (miR34a, miR538e, miR193e, and miR198) which show the most significant differential expression after in vivo niche exposure at four months (hematogenous spread).

• To determine whether altered miR expression reflects or causes the metastatic invasion pattern of AML.

OUTLINE: Bone marrow-derived mesenchymal stromal cell (MSC) samples are implanted subcutaneously in NOD/SCID mice. Cells are then harvested at day 0, 1 month, and 4 months post-implantation. miRNA is isolated and analyzed by Ilumina MicroRNA Expression Profiling single Beadchip. The obtained data is then analyzed by the Illumina Genome Studio Analysis Software.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia

• Fresh human bone marrow samples obtained from orthopedic surgery at the Tissue Donation Program of The Feinstein Institute and the Children Oncology Group (COG) Myeloid Disease Biorepository

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Genetic:
• RNA analysis

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	miR expression patterns in pediatric AML are regulated by the niche MSC-associated microenvironment			No
Primary	Exposure of AML cells to the niche MSCs generate changes in pediatric AML miR expression profiles			No
Primary	Correlation between changes in pediatric AML miR expression profiles and changes in biological behavior of AML cells (dormant versus invasive)			No