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CompletedNCT01290107Updated May 18, 2016

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

An observational study in Leukemia, sponsored by Children's Oncology Group. Completed. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2016-05-18.

Sponsored by Children's Oncology Group · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
9
Ages
Up to 30 Years
Sex
All
01

Study summary

RATIONALE: 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.

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

Read the detailed description

OBJECTIVES:

  • To successfully transplant human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells.
  • To harvest the cells and use chromatin immunoprecipitation (ChIP) methods to identify the locations of the protein complexes on the genome.
  • To study the interactions of the Super Elongation Complex (SEC) and Dot1 Complex (DotCom) complexes in human leukemia samples.
  • To compare the genomic targets of the complexes formed by MLL-ENL chimeras to non-MLL-rearranged leukemia samples to normal controls.

OUTLINE: Cryopreserved cells are implanted into NOD SCID gamma mice, expanded, harvested, and studied by chromatin immunoprecipitation (ChIP) methods (using antibodies to ENL, Af9, and AF10). Results are then analyzed by PCR, DNA sequencing, and/or microarray analysis.

02

Conditions studied

  • Leukemia

Keywords

  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • childhood acute myeloid leukemia/other myeloid malignancies
03

In context

Leukemia

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

This study's planned enrollment of 9 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

Diagnosis of acute myeloid leukemia.

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia (AML)
  • Cryopreserved mixed-lineage leukemia (MLL) ENL AML rearrangement cells, normal karyotype and non-MLL rearrangement AML cells, and non-leukemic bone marrow samples from the COG tissue bank

    • 3 specimens of each type

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
9 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • GeneticDNA analysis
  • Geneticgene rearrangement analysis
  • Geneticmicroarray analysis
  • Geneticpolymerase chain reaction
  • Otherimmunological diagnostic method
  • Otherlaboratory biomarker analysis
06

What researchers measure

Primary outcomes

  1. Successful transplantation of human acute myeloid leukemia (AML) cells into immunocompromised mice for the purpose of expansion of the cells

Secondary outcomes

  1. Identification of the locations of the protein complexes

  2. Interactions of the SEC and DotCom complexes in human leukemia samples

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01290107
Lead sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 4, 2011
Start date
Feb 2011
Primary completion
Jan 2015
Completion
May 2016
Last update
May 18, 2016

Study contacts

Eric Guest, MD
principal investigator · Children's Mercy Hospital Kansas City

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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