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Identifying Cancer Genes in in Blood and Bone Marrow Samples From Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00897182
First Posted: May 12, 2009
Last Update Posted: July 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
  Purpose

RATIONALE: Studying samples of blood and bone marrow in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify genes related to cancer. It may also help doctors diagnose cancer and predict how patients will respond to treatment.

PURPOSE: This research study is identifying cancer-related genes in blood and/or bone marrow samples from patients with acute myeloid leukemia.


Condition Intervention
Leukemia Genetic: microarray analysis Genetic: polymerase chain reaction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Identification of Target Genes for Diagnosis and Prognosis of AML Using a Custom-Design Microarray

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Correlation of increased or decreased expression of same transcripts with disease outcome [ Time Frame: baseline ]
  • Minimum number of genes that can be used for precise diagnosis of each of the three subtypes of acute myeloid leukemia [ Time Frame: baseline ]
  • Identification of individual genes that are differentially expressed between the subtypes of AMLs [ Time Frame: baseline ]
  • Correlation of the patterns of expression of the translocation-specific transcripts with age, sex, race, response to treatment, survival, and with other known mutations [ Time Frame: baseline ]

Biospecimen Retention:   Samples With DNA
Bone marrow and/or peripheral blood obtained at diagnosis from AML patients enrolled on CALGB AML treatment studies.

Enrollment: 96
Study Start Date: May 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
This is a CALGB Leukemia Tissue Bank project makes use of tissue from patients who have previously provided their consent. Diagnostic samples from patients enrolled on CALGB AML treatment studies (eg, CALGB 9621, 9710, and 19808) and who have been registered on the companion Leukemia Tissue Bank Protocol CALGB 9665 were used.
Genetic: microarray analysis Genetic: polymerase chain reaction

Detailed Description:

OBJECTIVES:

  • To identify and validate individual genes for diagnosis of three major translocations in acute myeloid leukemia.
  • To correlate transcript expression data in the various translocations with age, sex, race, response to treatment, and survival and with other known mutations.

OUTLINE: Blood and/or bone marrow samples previously procured from patients on CALGB-9665 are obtained from the CALGB Leukemia Tissue Bank from patients enrolled on CALGB AML treatment studies. Mononuclear cells are isolated from samples and mRNA is extracted. Gene expression profiles are analyzed via custom mRNA microarray and confirmed by quantitative real-time PCR.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with acute myeloid leukemia.
Criteria
  • Enrolled on CALGB acute myeloid leukemia (AML) treatment studies AND concurrently enrolled on Leukemia Tissue Bank Protocol CALGB-9665
  • Short-term or long-term survivor
  • Bone marrow and/or peripheral blood obtained at diagnosis
  • Leukemia is one of the following cytogenetic subtypes:

    • t(8;21)
    • t(15;17)
    • inv(16)
  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): NCT00897182


Locations
United States, Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46845
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Janet Rowley, MD University of Chicago
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00897182     History of Changes
Other Study ID Numbers: CALGB-20801
CDR0000595708 ( Registry Identifier: NCI Physician Data Query )
NCI-2009-00462 ( Registry Identifier: NCI Clinical Trials Reporting Program )
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: July 4, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(8;21)(q22;q22)
childhood acute myeloid leukemia in remission
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
secondary acute myeloid leukemia
untreated adult acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies

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