Biomarker Expression in Samples From Young Patients With Anaplastic Large Cell Lymphoma

May 17, 2016 updated by: Children's Oncology Group

Expression of T Immunoregulatory Proteins in ALK+ Anaplastic Large Cell Lymphoma (ALCL)

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment.

PURPOSE: This research trial studies biomarker expression in tissue samples from young patients with anaplastic large cell lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To determine the expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in anaplastic large cell lymphoma (ALCL).
  • To correlate the expression of these proteins with the levels of anaplastic lymphoma kinase (ALK) autoantibodies in patient of ANHL0131.

OUTLINE: Archived tissue microarray samples are analyzed by mass spectrometry and validated by Western blotting, flow cytometry, and IHC.

Study Type

Observational

Enrollment (Anticipated)

7

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 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diagnosis of anaplastic large cell lymphoma.

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of anaplastic large cell lymphoma
  • Tissue microarray samples available from the Cooperative Human Tissue Network (CHTN)

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
Expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in ALCL
Correlation of CD4, FOXP3, and CD276 with ALK autoantibody response in patients enrolled in ANHL0131

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: Megan S. Lim, MD, PhD, C.S. Mott Children's Hospital at University of Michigan Medical Center

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

May 1, 2011

Primary Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

June 2, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (ESTIMATE)

June 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANHL11B1 (OTHER: Children's Oncology Group)
  • COG-ANHL11B1 (OTHER: Children's Oncology Group)
  • NCI-2011-02860 (REGISTRY: 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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