NCT01251159

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 laboratory study is studying 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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2009

Shorter than P25 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

May 15, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2010

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

1 month

First QC Date

November 30, 2010

Last Update Submit

May 16, 2017

Conditions

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with del(5q)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)untreated adult acute myeloid leukemiaadult acute minimally differentiated myeloid leukemia (M0)adult acute myeloblastic leukemia with maturation (M2)adult acute myeloblastic leukemia without maturation (M1)adult acute myelomonocytic leukemia (M4)adult acute monoblastic leukemia (M5a)adult acute monocytic leukemia (M5b)adult erythroleukemia (M6a)adult pure erythroid leukemia (M6b)adult acute megakaryoblastic leukemia (M7)

Outcome Measures

Primary Outcomes (1)

  • Define somatic mutations occurring in de novo AML

    1 month

Interventions

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Samples from patients enrolled on E1900 from whom samples were submitted for research

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia * Bone marrow samples must meet 1 of the following criteria: * Normal karyotype from patients enrolled on ECOG-1900 archived at the ECOG Leukemia Tissue Bank * Live, sortable mononuclear cells prepared at the time of initial diagnosis (slow-frozen in media with 10% DMSO OR fresh cells shipped immediately * Age-matched healthy control samples from commercial providers 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

MeSH Terms

Conditions

LeukemiaCongenital AbnormalitiesLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Monocytic, AcuteLeukemia, Erythroblastic, AcuteLeukemia, Megakaryoblastic, Acute

Interventions

Polymerase Chain ReactionImmunologic Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification TechniquesGenetic TechniquesInvestigative Techniques

Study Officials

  • Ulrich G. Steidl, MD, BS

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 1, 2010

Study Start

May 15, 2009

Primary Completion

June 15, 2009

Study Completion

June 15, 2009

Last Updated

May 17, 2017

Record last verified: 2017-05