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NCT00899873 Clinical Trial

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

Leukemia Clinical Trial

Official title:
Proposed Study of CLL Samples

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00899873
Other study ID # CDR0000617494
Secondary ID ECOG-E2997T1
Status Completed
Phase N/A
First received May 9, 2009
Last updated May 16, 2017
Start date April 17, 2012
Est. completion date July 17, 2012

Study information
Verified date May 2017
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

OBJECTIVES:

- 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.

Recruitment information / eligibility
Status Completed
Enrollment 225
Est. completion date July 17, 2012
Est. primary completion date July 17, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• cytogenetic analysis

Other:
• flow cytometry

• fluorescence activated cell sorting

• immunoenzyme technique

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of biomarker analysis and correlation with outcome response 1 month
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