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Diagnostic Study of Gene Alterations in Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00003931
Recruitment Status : Completed
First Posted : August 20, 2003
Last Update Posted : July 4, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Leukemia Genetic: reverse transcriptase-polymerase chain reaction

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.


Study Design

Study Type : Observational
Actual Enrollment : 9769 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of the Partial Tandem Duplication of ALL1 (MLL) in Patients With Acute Myeloid Leukemia- A CALGB Leukemia Tissue Bank Project
Study Start Date : February 1999
Primary Completion Date : June 2006
Study Completion Date : June 2006


Groups and Cohorts

Group/Cohort Intervention/treatment
blood or bone marrow samples

All 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.

Genetic: reverse transcriptase-polymerase chain reaction


Outcome Measures

Primary Outcome Measures :
  1. frequency of partial tandem duplication of ALL1 (MLL) [ Time Frame: Up to 10 years ]

Secondary Outcome Measures :
  1. predictive value of partial tandem duplication of ALL1 [ Time Frame: Up to 10 years ]

Biospecimen Retention:   Samples With DNA
blood or bone marrow samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients previously enrolled on CALGB-9665.
Criteria

DISEASE CHARACTERISTICS:

  • Prior registration on protocol CALGB-9665
  • Diagnosed with acute myeloid leukemia (AML)
  • Treated on a CALGB AML treatment protocol
  • Diagnostic bone marrow or blood specimen available

PATIENT CHARACTERISTICS:

Age:

  • 15 and over
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003931


  Show 46 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Michael A. Caligiuri, MD Ohio State University Comprehensive Cancer Center
More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003931     History of Changes
Other Study ID Numbers: CALGB-9769
U10CA031946 ( U.S. NIH Grant/Contract )
CLB-9769
CDR0000067123 ( Registry Identifier: NCI Physician Data Query )
First Posted: August 20, 2003    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent adult acute myeloid leukemia
adult acute myeloid leukemia in remission

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms