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Completed

NCT Number: NCT00898157

Study of Biomarkers Using Tissue Samples From Older Patients With Diffuse Large B-Cell Lymphoma Treated With Combination Chemotherapy With or Without Rituximab on Clinical Trial ECOG-E4494

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 understand how patients respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers using tissue samples from older patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or without rituximab on clinical trial ECOG-E4494.

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Key information

About this study

OBJECTIVES:

  • To construct tissue microarrays (TMA) using tissue samples from older patients with diffuse large B-cell lymphoma treated with standard CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone) with or without rituximab on clinical trial ECOG-E4494.
  • To allow this TMA resource to be included in a large international effort (the Lunenburg Lymphoma Biomarker Consortium [LLBC]), partnering with several other similar randomized trials (EORTC, HOVON, GELA, MINT) in order to properly power and bring standardization to the study of biomarkers in lymphoma.
  • To evaluate the clinical impact and prognostic importance of a number of biomarkers, including Bcl-2, Bcl-6, CD10, FOXP1, MUM1, Ki-67, CD5, and HLA-Dr.
  • To determine the prognostic impact of clinical International Prognostic Index (IPI) variables in a large international study.
  • To determine the relationship between different biomarkers and clinical predictors.
  • To establish the TMA (using tissue samples from patients treated on clinical trial ECOG-E4494) as a resource for future ECOG-driven studies and for validation of novel biomarkers as they become recognized and available.

OUTLINE: Patients are stratified according to prior treatment (CHOP chemotherapy [cyclophosphamide, doxorubicin, vincristine, and prednisone] or CHOP-like chemotherapy vs CHOP chemotherapy with or without rituximab).

Tissue microarrays will be constructed using tissue samples previously collected from patients treated on clinical trial ECOG-E4494. Tissue microarrays will be used for biomarker studies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of diffuse large B-cell lymphoma
  • Received treatment on clinical trial ECOG-E4494

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Treatment and study plan

laboratory biomarker analysis

Other

Primary outcomes

  1. Correlation of biomarkers with response and outcome

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Analysis of E4494 Tissues to Determine the Prognostic Significance of Biomarkers in Diffuse Large B Cell Lymphoma (DLBCL) Treated With Standard Chemotherapy (CHOP) Plus Rituximab ®)1

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 12, 2009
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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