Biomarkers in Tissue Samples From Patients With Acute Promyelocytic Leukemia

September 30, 2015 updated by: Children's Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients With Acute Promyelocytic Leukemia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Demonstration that S100A10 is expressed on acute promyelocytic leukemia cells and that levels of S100A10 correspond to the amount of fibrinolytic activity
Evaluation of the impact of all-trans retinoic acid (ATRA) on S100A10 level and fibrinolytic activity in vitro
Evaluation of the impact of S100A10 knockdown on fibrinolytic activity
Correlation of in vitro findings in cell culture to primary patient samples both pre- and post-ATRA therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jason N. Berman, MD, IWK Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

October 30, 2010

First Submitted That Met QC Criteria

October 30, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAML11B5 (Other Identifier: Children's Oncology Group)
  • COG-AAML11B5 (Other Identifier: Children's Oncology Group)
  • NCI-2011-02844 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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