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CompletedNCT01642121Updated May 19, 2016

Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia

An observational study in Childhood Acute Monoblastic Leukemia (M5a), Childhood Acute Monocytic Leukemia (M5b) and Childhood Acute Myeloblastic Leukemia Without Maturation (M1), sponsored by Children's Oncology Group. Completed at 1 site in United States. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2016-05-19.

Sponsored by Children's Oncology Group · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
20
Ages
Up to 30 Years
Sex
All
01

Study 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

Read the 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).

02

Conditions studied

  • 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)
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 20 is below the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 436 studies on the registry; 34 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

childhood acute myeloid leukemia (AML) patients

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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
20 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

    Other: laboratory biomarker analysis

Interventions

  • Otherlaboratory biomarker analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Expression of the CD55 marker on CD34+CD38- cells

    Time frame: Up to 6 months

  2. Presence of the AML1-ETO translocation

    Time frame: Up to 6 months

07

Study locations

1 site
  • Children's Oncology Group
    Monrovia, California 91006-3776, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01642121
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 17, 2012
Start date
Aug 2012
Primary completion
May 2016
Last update
May 19, 2016

Study contacts

Stephanie Heidemann, MD
principal investigator · Children's Oncology Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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