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Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01138306
First Posted: June 7, 2010
Last Update Posted: May 18, 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):
Children's Oncology Group
  Purpose

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from young patients with acute myeloid leukemia.


Condition Intervention
Leukemia Genetic: gene expression analysis Genetic: mutation analysis Other: flow cytometry Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Implications of s-SHIP Expression and SHIP Alterations in AML

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival

Secondary Outcome Measures:
  • Overall survival
  • Relapse rate

Biospecimen Retention:   Samples With DNA
tissue

Estimated Enrollment: 149
Study Start Date: February 2013
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the extent and prognostic implications of variable s-SHIP expression and SHIP gene mutations in pediatric patients with acute myeloid leukemia.
  • Determine the effects of aberrant s-SHIP expression on the PI3K/Akt pathway in these patients via electrochemiluminescence and phosphospecific flow cytometry assays.

OUTLINE: RNA samples are analyzed for variable s-SHIP expression and are screened for SHIP mutations. Cryopreserved cells (with known high- or low-s-SHIP expression) are analyzed for the levels of various components of the PI3K/Akt pathway via electrochemiluminescence and phosphospecific flow cytometry.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  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): NCT01138306


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Phoenix Ho, MD Fred Hutchinson Cancer Research Center
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01138306     History of Changes
Other Study ID Numbers: AAML10B5
COG-AAML10B5 ( Other Identifier: Children's Oncology Group )
CDR0000671462 ( Other Identifier: Clinical Trials.gov )
NCI-2011-02223 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: June 4, 2010
First Posted: June 7, 2010
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
childhood acute myeloid leukemia/other myeloid malignancies

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