NCT00899743

Brief Summary

RATIONALE: Studying samples of blood and 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 blood and bone marrow samples from patients with previously untreated primary acute myeloid leukemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2008

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

August 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

May 9, 2009

Last Update Submit

March 5, 2015

Conditions

Keywords

adult erythroleukemia (M6a)adult pure erythroid leukemia (M6b)adult acute megakaryoblastic leukemia (M7)adult acute minimally differentiated myeloid leukemia (M0)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)adult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesuntreated adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

  • Association of specific clinicopathological variables and outcomes with calmodulin-dependent protein kinase II-γ (CaMKIIγ) activation (autophosphorylation)

    upon receipt of specimens

Interventions

polyacrylamide gel electrophoresis

western blotting

immunologic technique

laboratory biomarker analysis

Eligibility Criteria

Age56 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

specimens from S9333

DISEASE CHARACTERISTICS: * Cryopreserved specimens of marrow or peripheral blood from patients enrolled in clinical trial SWOG-9333 and meeting the following criteria: * Diagnosis of primary acute myeloid leukemia * No M3 disease * Previously untreated disease * Randomized to remission induction chemotherapy with mitoxantrone hydrochloride and etoposide (Arm II) 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.

  • 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.

MeSH Terms

Conditions

LeukemiaLeukemia, Erythroblastic, AcuteLeukemia, Megakaryoblastic, AcuteLeukemia, Monocytic, AcuteLeukemia, Myeloid, AcuteLeukemia, Myelomonocytic, AcuteCongenital Abnormalities

Interventions

Electrophoresis, Polyacrylamide GelBlotting, WesternImmunologic Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ElectrophoresisChemistry Techniques, AnalyticalInvestigative TechniquesElectrochemical TechniquesImmunoblottingImmunoassayMolecular Probe Techniques

Study Officials

  • Steven J. Collins, MD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

August 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 6, 2015

Record last verified: 2015-03