- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00898963
Biomarkers in Patients With Stage III or Stage IV Follicular Lymphoma Treated on Clinical Trial E-1496
Identification of Biomarkers in Follicular Lymphoma
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 respond to treatment.
PURPOSE: This laboratory study is looking at biomarkers in patients with stage III or stage IV follicular lymphoma treated on clinical trial E-1496.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Correlate gene expression profiles with progression-free survival (PFS) of patients with stage III or IV follicular lymphoma treated with cyclophosphamide, vincristine, and prednisone with or without rituximab on clinical trial E-1496.
- Determine if immunoglobulin Fc-gamma receptor polymorphisms are predictive of PFS in these patients.
- Assess the significance of the microenvironment by constructing tissue microarrays of follicular lymphoma and immunostaining with relevant biomarkers.
- Correlate relevant biomarkers with clinical features, response, and PFS.
OUTLINE: This is a multicenter study.
Tissue samples are analyzed by gene expression profiling, microarrays to predict gene expression, immunohistochemistry, and immunoglobulin Fc-gamma receptor polymorphism analysis for biological markers.
PROJECTED ACCRUAL: A total of 175 samples will be accrued for this study.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
Diagnosis of follicular lymphoma
- Stage III or IV disease
- Received cyclophosphamide, vincristine, and prednisone with or without rituximab on clinical trial E-1496
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation of gene expression profiles with progression-free survival (PFS)
Time Frame: 1 month
|
1 month
|
Prediction of PFS by immunoglobulin Fc-gamma receptor polymorphisms as assessed by immunohistochemistry
Time Frame: 1 month
|
1 month
|
Assessment of significance of microenvironment by constructing tissue microarrays and immunostaining with relevant biomarkers
Time Frame: 1 month
|
1 month
|
Correlation of relevant biomarkers with clinical features, response, and PFS
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Randall D. Gascoyne, MD, British Columbia Cancer Agency
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000544400
- ECOG-E1496T1
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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