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Biomarkers in Patients With Stage III or Stage IV Follicular Lymphoma Treated on Clinical Trial E-1496

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ClinicalTrials.gov Identifier: NCT00898963
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

May 9, 2009
May 12, 2009
May 19, 2017
April 18, 2007
December 21, 2011   (Final data collection date for primary outcome measure)
  • Correlation of gene expression profiles with progression-free survival (PFS) [ Time Frame: 1 month ]
  • Prediction of PFS by immunoglobulin Fc-gamma receptor polymorphisms as assessed by immunohistochemistry [ Time Frame: 1 month ]
  • Assessment of significance of microenvironment by constructing tissue microarrays and immunostaining with relevant biomarkers [ Time Frame: 1 month ]
  • Correlation of relevant biomarkers with clinical features, response, and PFS [ Time Frame: 1 month ]
  • Correlation of gene expression profiles with progression-free survival (PFS)
  • Prediction of PFS by immunoglobulin Fc-gamma receptor polymorphisms as assessed by immunohistochemistry
  • Assessment of significance of microenvironment by constructing tissue microarrays and immunostaining with relevant biomarkers
  • Correlation of relevant biomarkers with clinical features, response, and PFS
Complete list of historical versions of study NCT00898963 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
Observational Model: Other
Time Perspective: Retrospective
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Non-Probability Sample
Samples submitted for research from patients participating in E1496
Lymphoma
  • Genetic: gene expression analysis
  • Genetic: microarray analysis
  • Genetic: polymorphism analysis
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunohistochemistry staining method
  • Other: immunologic technique
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
175
Same as current
December 21, 2011
December 21, 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00898963
CDR0000544400
ECOG-E1496T1
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Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Study Chair: Randall D. Gascoyne, MD British Columbia Cancer Agency
Eastern Cooperative Oncology Group
May 2017