NCT01642121

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

3.8 years

First QC Date

July 13, 2012

Last Update Submit

May 17, 2016

Conditions

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

Outcome Measures

Primary Outcomes (2)

  • Expression of the CD55 marker on CD34+CD38- cells

    Up to 6 months

  • Presence of the AML1-ETO translocation

    Up to 6 months

Study Arms (1)

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

laboratory biomarker analysisOTHER

Correlative studies

Observational

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

childhood acute myeloid leukemia (AML) patients

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

bone marrow

Study Officials

  • Stephanie Heidemann, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 17, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

US(1)