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DNA Analysis of Tumor Tissue From Patients With Acute Myeloid Leukemia

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.
 
ClinicalTrials.gov Identifier: NCT00897936
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Study Description
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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. It may also help doctors predict how well patients respond to treatment.

PURPOSE: This laboratory study is looking at tissue samples from patients with acute myeloid leukemia.


Condition or disease Intervention/treatment
Leukemia Genetic: DNA methylation analysis Genetic: comparative genomic hybridization Genetic: fluorescence in situ hybridization Genetic: microarray analysis Genetic: polymerase chain reaction Other: diagnostic laboratory biomarker analysis Other: immunologic technique

Detailed Description:

OBJECTIVES:

Primary

  • Determine gene expression, genome integrity, cytosine methylation, and chromatin structure in patients with normal cytogenetics leukemia (NCL) acute myeloid leukemia.
  • Determine whether NCL can be deconstructed into specific disease entities by analysis of the integrated genomic and epigenomic datasets using supervised and unsupervised methods in these patients.
  • Identify the gene pathways that define NCL subtypes and molecular targets for validation in preclinical and clinical trials for these patients.
  • Determine whether integrated analysis provides markers of prognostic and therapeutic response that accurately predicts clinical outcome and can be used to select patients for risk-stratified therapeutic trials.

OUTLINE: This is a pilot, multicenter study.

Samples are analyzed to assess array comparative genomic hybridization using polymerase chain reaction (PCR) and fluorescent in situ hybridization; chromatin immunoprecipitations (chip) using PCR; Hpa II tiny fragment enrichment by ligation-mediated PCR (HELP) using DNA methylation analysis; and gene expression profiling.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Study Design
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Study Type : Observational
Actual Enrollment : 418 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Pilot Study to Characterize the Genomic and Epigenomic Signature of NPM Positive Vs. NPM Negative NCL
Actual Study Start Date : March 23, 2006
Actual Primary Completion Date : October 15, 2009
Actual Study Completion Date : October 15, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Nucleophosmin exon 12 mutation-related normal cytogenetics leukemia (NCL) has a specific genetic and epigenetic profile [ Time Frame: 1 day ]
  2. Relatedness on a per-gene basis of cross-platform data [ Time Frame: 1 day ]
  3. Ability of supervised clustering to distinguish subgroups according to clinical prognostic and biomarker indicators [ Time Frame: 1 day ]
  4. Ability of unsupervised clustering to identify subgroups of NCL patients [ Time Frame: 1 day ]
  5. Relative power of each platform mentioned above vs the integrated platforms [ Time Frame: 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia
  • Enrolled on clinical trial ECOG-E1900

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Contacts and Locations
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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): NCT00897936


Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Ari M. Melnick, MD Albert Einstein College of Medicine
More Information
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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00897936    
Other Study ID Numbers: CDR0000476571
ECOG-E1900T2
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
adult acute myeloid leukemia in remission
recurrent adult acute myeloid leukemia
untreated adult acute myeloid leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
 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(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
Additional relevant MeSH terms:
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Leukemia
Neoplasms by Histologic Type
Neoplasms