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Biomarkers in Patients With Stage III or Stage IV Follicular Lymphoma Treated on Clinical Trial E-1496
This study is ongoing, but not recruiting participants.
First Received: May 9, 2009   Last Updated: May 16, 2009   History of Changes
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00898963
  Purpose

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.


Condition Intervention
Lymphoma
 Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: polymorphism analysis
Other: immunohistochemistry staining method
Other: immunologic technique
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Identification of Biomarkers in Follicular Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Correlation of gene expression profiles with progression-free survival (PFS) [ Designated as safety issue: No ]
  • Prediction of PFS by immunoglobulin Fc-gamma receptor polymorphisms as assessed by immunohistochemistry [ Designated as safety issue: No ]
  • Assessment of significance of microenvironment by constructing tissue microarrays and immunostaining with relevant biomarkers [ Designated as safety issue: No ]
  • Correlation of relevant biomarkers with clinical features, response, and PFS [ Designated as safety issue: No ]

Estimated Enrollment: 175
Study Start Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898963

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Sandra J. Horning, MD Stanford University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000544400, ECOG-E1496T1
Study First Received: May 9, 2009
Last Updated: May 16, 2009
ClinicalTrials.gov Identifier: NCT00898963     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
 stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
 Lymphoproliferative Disorders
Follicular Lymphoma
Lymphoma

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
 Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on September 11, 2009



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