Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Studying Gene Expression in Tissue Samples 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: 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

Tracking Information
First Submitted Date January 26, 2010
First Posted Date January 27, 2010
Last Update Posted Date October 2, 2015
Study Start Date January 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 26, 2010)
Correlation of high relative expression levels of PLAGL2 and putative PLAGL2 target genes with potential pathogenic relevance
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01057095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Studying Gene Expression in Tissue Samples From Patients With Acute Myeloid Leukemia
Official Title Mechanisms of PLAGL2-Induced Leukaemogenesis
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.

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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
tissue
Sampling Method Non-Probability Sample
Study Population Diagnosis of acute myeloid leukemia
Condition Leukemia
Intervention
  • Genetic: RNA analysis
  • Genetic: gene expression analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: laboratory biomarker analysis
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 26, 2010)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 120 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01057095
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) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Children's Oncology Group
Study Sponsor Children's Oncology Group
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Soheil Meshinchi, MD Fred Hutchinson Cancer Research Center
PRS Account Children's Oncology Group
Verification Date May 2015