DNA Analysis of Tumor Tissue From Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897936
First received: May 9, 2009
Last updated: July 6, 2011
Last verified: March 2007
  Purpose

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 Intervention
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

Study Type: Observational
Official Title: A Pilot Study to Characterize the Genomic and Epigenomic Signature of NPM Positive Vs. NPM Negative NCL

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Nucleophosmin exon 12 mutation-related normal cytogenetics leukemia (NCL) has a specific genetic and epigenetic profile [ Designated as safety issue: No ]
  • Relatedness on a per-gene basis of cross-platform data [ Designated as safety issue: No ]
  • Ability of supervised clustering to distinguish subgroups according to clinical prognostic and biomarker indicators [ Designated as safety issue: No ]
  • Ability of unsupervised clustering to identify subgroups of NCL patients [ Designated as safety issue: No ]
  • Relative power of each platform mentioned above vs the integrated platforms [ Designated as safety issue: No ]

Estimated Enrollment: 32
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897936

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Ari M. Melnick, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00897936     History of Changes
Other Study ID Numbers: CDR0000476571, ECOG-E1900T2
Study First Received: May 9, 2009
Last Updated: July 6, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 29, 2014