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
  Purpose

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.


Condition Intervention
Leukemia
Genetic: protein expression analysis
Genetic: western blotting
Other: flow cytometry
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Regulation of S100A10 by the PML-RAR-alpha Oncoprotein

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: November 2010
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01232855

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Jason N. Berman, MD IWK Health Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01232855     History of Changes
Other Study ID Numbers: CDR0000687909, COG-AAML11B5
Study First Received: October 30, 2010
Last Updated: October 25, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute promyelocytic leukemia (M3)
childhood acute promyelocytic leukemia (M3)
adult acute myeloid leukemia in remission
untreated adult acute myeloid leukemia
childhood acute myeloid leukemia in remission
untreated childhood acute myeloid leukemia and other myeloid malignancies

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

ClinicalTrials.gov processed this record on October 19, 2014