NCT01059734

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 biomarker expression in 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
357

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

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

January 29, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

January 29, 2010

Last Update Submit

March 5, 2015

Conditions

Leukemia

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)recurrent adult acute myeloid leukemiauntreated adult acute myeloid leukemiaadult erythroleukemia (M6a)adult pure erythroid leukemia (M6b)adult acute monoblastic leukemia (M5a)adult acute monocytic leukemia (M5b)adult acute myeloblastic leukemia with maturation (M2)adult acute myeloblastic leukemia without maturation (M1)adult acute myelomonocytic leukemia (M4)secondary acute myeloid leukemiaadult acute minimally differentiated myeloid leukemia (M0)adult acute megakaryoblastic leukemia (M7)

Outcome Measures

Primary Outcomes (4)

  • Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms

    immediate

  • Distributions of mutations in TOP2 phosphorylation sites

    immediate

  • Correlation of TOP2 expression with complete remission rates, relapse-free survival, and overall survival

    immediate

  • Variation of TOP2 expression and mutations in TOP2 phosphorylation sites among patients and disease characteristics

    immediate

Interventions

DNA analysisGENETIC
RNA analysisGENETIC
mutation analysisGENETIC
polymerase chain reactionGENETIC
polymorphism analysisGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients enrolled on S0931, S9126, S9333 or S9500 consenting to use of specimens for future research

DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia * All subtypes allowed (except acute promyelocytic leukemia \[M3\]) * Previously untreated OR relapsed/refractory disease * Isolated RNA specimens from bone marrow aspirate samples available from patients who participated on SWOG-9031, SWOG-9333 (cytarabine/daunorubicin hydrochloride induction arm only), SWOG-9500, or SWOG-9126 PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

Related Publications (2)

  • Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19.

    PMID: 25527568DERIVED

  • Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.

    PMID: 24383844DERIVED

MeSH Terms

Conditions

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

Interventions

Polymerase Chain ReactionAmplified Fragment Length Polymorphism Analysis

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 TechniquesDNA Fingerprinting

Study Officials

  • Anjali Advani, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 1, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 6, 2015

Record last verified: 2015-03