NCT01290107

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

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

Study Start

First participant enrolled

February 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

3.9 years

First QC Date

February 3, 2011

Last Update Submit

May 17, 2016

Conditions

Leukemia

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitieschildhood acute myeloid leukemia/other myeloid malignancies

Outcome Measures

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 (2)

  • Identification of the locations of the protein complexes

  • Interactions of the SEC and DotCom complexes in human leukemia samples

Interventions

DNA analysisGENETIC
gene rearrangement analysisGENETIC
microarray analysisGENETIC
polymerase chain reactionGENETIC
immunological diagnostic methodOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

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

Diagnosis of acute myeloid leukemia.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Bone Marrow

MeSH Terms

Conditions

LeukemiaCongenital Abnormalities

Interventions

Gene RearrangementMicroarray AnalysisPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Genetic PhenomenaMicrochip Analytical ProceduresInvestigative TechniquesNucleic Acid Amplification TechniquesGenetic Techniques

Study Officials

  • Eric Guest, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 4, 2011

Study Start

February 1, 2011

Primary Completion

January 1, 2015

Study Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05