Biomarkers in Tissue Samples From Patients With Acute Promyelocytic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01232855
First received: October 30, 2010
Last updated: October 25, 2011
Last verified: October 2011

October 30, 2010
October 25, 2011
November 2010
February 2011   (final data collection date for primary outcome measure)
  • Demonstration that S100A10 is expressed on acute promyelocytic leukemia cells and that levels of S100A10 correspond to the amount of fibrinolytic activity [ Designated as safety issue: No ]
  • Evaluation of the impact of all-trans retinoic acid (ATRA) on S100A10 level and fibrinolytic activity in vitro [ Designated as safety issue: No ]
  • Evaluation of the impact of S100A10 knockdown on fibrinolytic activity [ Designated as safety issue: No ]
  • Correlation of in vitro findings in cell culture to primary patient samples both pre- and post-ATRA therapy [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01232855 on ClinicalTrials.gov Archive Site
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Biomarkers in Tissue Samples From Patients With Acute Promyelocytic Leukemia
Regulation of S100A10 by the PML-RAR-alpha Oncoprotein

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

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

OBJECTIVES:

  • Demonstrate that S100A10 is expressed on APL cells and that levels of S100A10 correspond to the amount of fibrinolytic activity.
  • Evaluate the impact of ATRA on S100A10 level and fibrinolytic activity in vitro.
  • Evaluate the impact of S100A10 knockdown on fibrinolytic activity.
  • Correlate in vitro findings in cell culture to primary patient samples both pre- and post-ATRA therapy.

OUTLINE: This is a multicenter study.

Previously collected samples are analyzed via flow cytometry and western blot analysis. Cell surface levels of S100A10 and annexin A2 are correlated to the promyelocyte population and total protein levels are examined to determine total annexin A2 and S100A10 in acute promyelocytic leukemia cells.

Observational
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Leukemia
  • Genetic: protein expression analysis
  • Genetic: western blotting
  • Other: flow cytometry
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
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February 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of acute promyelocytic leukemia
  • Available cryopreserved cells from diagnosis or cryopreserved cells from remission (germline)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01232855
CDR0000687909, COG-AAML11B5
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Gregory H. Reaman, Children's Oncology Group - Group Chair Office
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Jason N. Berman, MD IWK Health Centre
National Cancer Institute (NCI)
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP