Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia

NCT ID: NCT01642121

Last Updated: 2016-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31

Brief Summary

This laboratory study is looking into biomarkers in samples from younger patients with acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Detailed Description

Study Subtype: Observational Observational Study Model: Case-control Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Cryopreserved bone marrow samples Study Population Description: Patient samples with the AML1-ETO translocation and cytologically normal AML samples for controls Sampling Method: Non-Probability Sample

OBJECTIVES:

I. To address whether the mutation-specific cell-surface markers observed in murine system will allow the prospective isolation of leukemia stem cells (LSC) from human bone marrow samples that have the same cytogenetic abnormalities.

II. To compare the incidence of leukemia in NSG mice that have received CD34+CD38 marker+ cells to NSG mice that receive what are hypothesized to be normal cells (CD34+CD38 marker-subset) from the same patient.

OUTLINE:

Samples and controls are sorted and re-sorted for CD34, CD38, and CD55 subsets by single-cell polymerase chain reaction (PCR) analysis, flow cytometry, and reverse-transcriptase PCR. Sorted cell subsets are then transplanted into NSG mice. Beginning 6 weeks after transplantation, peripheral blood samples are collected and analyzed for human lymphoid- and myeloid-lineage cells by fluorescence-activated cell sorting (FACS).

Conditions

Childhood Acute Monoblastic Leukemia (M5a); Childhood Acute Monocytic Leukemia (M5b); Childhood Acute Myeloblastic Leukemia Without Maturation (M1); Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies; Childhood Acute Myelomonocytic Leukemia (M4)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Observational

Samples and controls are sorted and re-sorted for CD34, CD38, and CD55 subsets by single-cell PCR analysis, flow cytometry, and reverse-transcriptase PCR. Sorted cell subsets are then transplanted into NSG mice. Beginning 6 weeks after transplantation, peripheral blood samples are collected and analyzed for human lymphoid- and myeloid-lineage cells by FACS.

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Frozen bone marrow aspirates obtained from childhood acute myeloid leukemia (AML) patients possessing defined cytogenetic mutations; AML1-ETO or inv(16)
• Samples of cytogenetically normal AML cases obtained from the University of Alabama at Birmingham (UAB) as controls

• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Children's Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Heidemann, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

Children's Oncology Group

Monrovia, California, United States

Countries

United States

Other Identifiers

NCI-2012-01983

Identifier Type: REGISTRY

Identifier Source: secondary_id

AAML12B10

Identifier Type: -

Identifier Source: org_study_id