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Biomarkers in Samples From Patients With Chronic Lymphocytic Leukemia Treated on Clinical Trial ECOG-2997

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00899873
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 17, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Brief Summary:

RATIONALE: Studying samples of cells in the laboratory from patients with cancer may help identify biomarkers related to cancer. It may also help doctors learn how patients respond to treatment.

PURPOSE: This laboratory study is analyzing samples of cells from patients with chronic lymphocytic leukemia who were treated on clinical trial ECOG-2997.

Condition or disease Intervention/treatment
Leukemia Genetic: cytogenetic analysis Other: flow cytometry Other: fluorescence activated cell sorting Other: immunoenzyme technique Other: laboratory biomarker analysis

Detailed Description:


  • To analyze the expression of a variety of informative molecules using a unique high-resolution flow cytometric immunophenotyping technology in samples from patients with chronic lymphocytic leukemia enrolled in clinical trial ECOG-2997.

OUTLINE: Cell samples are analyzed for the following prognostic biomarkers: ZAP-70, phospho-Syk, phospho-GSK-3β, phospho-Akt, phospho-ZAP-70, cyclin D1, cyclin D2, p21cip1, phospho-ReIA, IkappaBα, Bax, Mcl-1, PTEN, phospho-Erk1/2, and phospho-MEK1/2. Biomarker signals are amplified using enzymatic amplification staining to obtain high resolution detection of cell-surface markers on leukemic cells. Biomarker expression levels are measured using fluorescence activated cell sorting analysis. Relationships between clinical outcomes, standard flow cytometric analysis, cytogenetic studies, and high resolution immunophenotyping will also be assessed.

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Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Proposed Study of CLL Samples
Actual Study Start Date : April 17, 2012
Actual Primary Completion Date : July 17, 2012
Actual Study Completion Date : July 17, 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Correlation of biomarker analysis and correlation with outcome response [ Time Frame: 1 month ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples submitted for research from patients enrolled on E2997


  • Stored frozen viable cells from patients with chronic lymphocytic leukemia treated on clinical trial ECOG-2997


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00899873

Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
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Study Chair: David Kaplan, MD, PhD University Hospitals Seidman Cancer Center
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Responsible Party: ECOG-ACRIN Cancer Research Group Identifier: NCT00899873    
Other Study ID Numbers: CDR0000617494
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017
Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
chronic lymphocytic leukemia
Additional relevant MeSH terms:
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Neoplasms by Histologic Type