Biomarkers in Tissue Samples From Patients With Acute Promyelocytic Leukemia

Leukemia Clinical Trial

Official title:

Regulation of S100A10 by the PML-RAR-alpha Oncoprotein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232855
• Other study ID #: AAML11B5
• Secondary ID: COG-AAML11B5NCI-
• Status: Completed
• Phase: N/A
• First received: October 30, 2010
• Last updated: September 30, 2015
• Start date: November 2010
• Est. completion date: February 2011

Study information

• Verified date: May 2015
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Promyelocytic, Acute

Intervention

Genetic:
• protein expression analysis

• western blotting

Other:
• flow cytometry

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration that S100A10 is expressed on acute promyelocytic leukemia cells and that levels of S100A10 correspond to the amount of fibrinolytic activity			No
Primary	Evaluation of the impact of all-trans retinoic acid (ATRA) on S100A10 level and fibrinolytic activity in vitro			No
Primary	Evaluation of the impact of S100A10 knockdown on fibrinolytic activity			No
Primary	Correlation of in vitro findings in cell culture to primary patient samples both pre- and post-ATRA therapy			No