MedPath

Diagnostic Study of Gene Alterations in Patients With Acute Myeloid Leukemia

Completed
Conditions
Leukemia
Interventions
Genetic: reverse transcriptase-polymerase chain reaction
Registration Number
NCT00003931
Lead Sponsor
Alliance for Clinical Trials in Oncology
Brief Summary

RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute myeloid leukemia and determine the extent of disease.

PURPOSE: Diagnostic study to try to detect changes in the genes of patients who have acute myeloid leukemia.

Detailed Description

OBJECTIVES:

* Determine the frequency of partial tandem duplication of ALL1 (MLL) in patients with acute myeloid leukemia (AML).

* Determine the predictive value of partial tandem duplication of ALL1 to identify a subset of AML patients who have a short duration of complete remission.

OUTLINE: All samples are obtained from specimens collected on CALGB-9665. No additional blood or bone marrow samples are collected.

Samples are examined by Southern blot analysis for gene rearrangement at 11q23. Samples showing evidence of ALL1 gene rearrangement are further analyzed by reverse transcription PCR amplification and/or cytogenetic analysis to detect partial tandem duplication of ALL1.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
9769
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
blood or bone marrow samplesreverse transcriptase-polymerase chain reactionAll samples are obtained from specimens collected on CALGB-9665. No additional blood or bone marrow samples are collected CALGB-9769. Samples are examined by Southern blot analysis for gene rearrangement at 11q23. Samples showing evidence of ALL1 gene rearrangement are further analyzed by reverse transcription PCR amplification and/or cytogenetic analysis to detect partial tandem duplication of ALL1.
Primary Outcome Measures
NameTimeMethod
frequency of partial tandem duplication of ALL1 (MLL)Up to 10 years
Secondary Outcome Measures
NameTimeMethod
predictive value of partial tandem duplication of ALL1Up to 10 years

Trial Locations

Locations (46)

University of California San Diego Cancer Center

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La Jolla, California, United States

Mount Sinai Medical Center, NY

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New York, New York, United States

CCOP - Christiana Care Health Services

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Wilmington, Delaware, United States

Lombardi Cancer Center

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Washington, District of Columbia, United States

Walter Reed Army Medical Center

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Washington, District of Columbia, United States

CCOP - Mount Sinai Medical Center

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Miami Beach, Florida, United States

University of Chicago Cancer Research Center

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Chicago, Illinois, United States

New York Presbyterian Hospital - Cornell Campus

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New York, New York, United States

Holden Comprehensive Cancer Center at The University of Iowa

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Iowa City, Iowa, United States

Roswell Park Cancer Institute

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Buffalo, New York, United States

Veterans Affairs Medical Center - Togus

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Togus, Maine, United States

Barnes-Jewish Hospital

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Saint Louis, Missouri, United States

Norris Cotton Cancer Center

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Lebanon, New Hampshire, United States

Veterans Affairs Medical Center - Buffalo

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Buffalo, New York, United States

Veterans Affairs Medical Center - White River Junction

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White River Junction, Vermont, United States

Veterans Affairs Medical Center - Memphis

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Memphis, Tennessee, United States

Veterans Affairs Medical Center - Richmond

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Richmond, Virginia, United States

Memorial Sloan-Kettering Cancer Center

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New York, New York, United States

Lineberger Comprehensive Cancer Center, UNC

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Chapel Hill, North Carolina, United States

MBCCOP - Massey Cancer Center

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Richmond, Virginia, United States

University of Tennessee, Memphis Cancer Center

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Memphis, Tennessee, United States

CCOP - North Shore University Hospital

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Manhasset, New York, United States

Schneider Children's Hospital at North Shore

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Manhasset, New York, United States

State University of New York - Upstate Medical University

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Syracuse, New York, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital)

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Chicago, Illinois, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

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Baltimore, Maryland, United States

University of Massachusetts Memorial Medical Center

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Worcester, Massachusetts, United States

Veterans Affairs Medical Center - Syracuse

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Syracuse, New York, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

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Syracuse, New York, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial)

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Columbia, Missouri, United States

Ellis Fischel Cancer Center - Columbia

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Columbia, Missouri, United States

Arthur G. James Cancer Hospital - Ohio State University

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Columbus, Ohio, United States

Vermont Cancer Center

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Burlington, Vermont, United States

Dana-Farber Cancer Institute

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Boston, Massachusetts, United States

CCOP - Southern Nevada Cancer Research Foundation

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Las Vegas, Nevada, United States

University of Minnesota Cancer Center

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Minneapolis, Minnesota, United States

Veterans Affairs Medical Center - Durham

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Durham, North Carolina, United States

Duke Comprehensive Cancer Center

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Durham, North Carolina, United States

Veterans Affairs Medical Center - Minneapolis

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Minneapolis, Minnesota, United States

Veterans Affairs Medical Center - Birmingham

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Birmingham, Alabama, United States

UCSF Cancer Center and Cancer Research Institute

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San Francisco, California, United States

Veterans Affairs Medical Center - San Francisco

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San Francisco, California, United States

University of Nebraska Medical Center

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Omaha, Nebraska, United States

CCOP - Southeast Cancer Control Consortium

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Winston-Salem, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University

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Winston-Salem, North Carolina, United States

Rhode Island Hospital

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Providence, Rhode Island, United States

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