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Studying Gene Expression in Tissue Samples From Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT01057095
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : October 2, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

RATIONALE: Studying samples of tissue 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 gene expression in tissue samples from patients with acute myeloid leukemia.


Condition or disease Intervention/treatment
Leukemia Genetic: RNA analysis Genetic: gene expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis

Detailed Description:

OBJECTIVES:

  • Screen acute myeloid leukemia (AML) samples to correlate high relative expression levels of PLAGL2 and putative PLAGL2 target genes (implicated in microarray study) with potential pathogenic relevance with respect to AML development.

OUTLINE: Cryopreserved mRNA from diagnostic samples is analyzed for gene expression by reverse transcriptase-PCR.


Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Mechanisms of PLAGL2-Induced Leukaemogenesis
Study Start Date : January 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Correlation of high relative expression levels of PLAGL2 and putative PLAGL2 target genes with potential pathogenic relevance

Biospecimen Retention:   Samples With DNA
tissue

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of acute myeloid leukemia
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia, including inv(16)(p13;q22) abnormalities

    • No t(15;17)(q22;q12) or t(8;21)(q22;q22) abnormalities

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01057095


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Soheil Meshinchi, MD Fred Hutchinson Cancer Research Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01057095     History of Changes
Other Study ID Numbers: AAML10B12
COG-AAML10B12 ( Other Identifier: Children's Oncology Group )
CDR0000664240 ( Other Identifier: Clinical Trials.gov )
NCI-2011-02208 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: May 2015

Keywords provided by Children's Oncology Group:
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with del(5q)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia in remission
 recurrent adult acute myeloid leukemia
untreated adult acute myeloid leukemia
childhood acute myeloid leukemia in remission
recurrent childhood 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