Biomarkers in Patients With Diffuse Large B-Cell Lymphoma Treated With Combination Chemotherapy With or Without Rituximab

NCT ID: NCT01131208

Last Updated: 2017-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-21

Study Completion Date

2010-08-21

Brief Summary

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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 well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in patients with diffuse large B-cell lymphoma treated with combination chemotherapy with or without rituximab.

Detailed Description

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OBJECTIVES:

* To identify genes predictive of clinical outcome (failure-free survival and overall survival) among patients with diffuse large B-cell lymphoma treated with CHOP or R-CHOP induction on ECOG-E4494 using the nuclease protection assay for measuring gene expression in paraffin-embedded tissue.
* To identify genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy.

OUTLINE: This is a multicenter study.

Unstained formalin-fixed, paraffin-embedded samples are analyzed for gene expression via nuclease protection assay.

Conditions

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Lymphoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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gene expression analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of diffuse large B-cell lymphoma
* Treated with CHOP or R-CHOP on ECOG-E4494

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Minimum Eligible Age

60 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane N. Winter, MD

Role: PRINCIPAL_INVESTIGATOR

Robert H. Lurie Cancer Center

Other Identifiers

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ECOG-E4494T2

Identifier Type: -

Identifier Source: secondary_id

CDR0000671515

Identifier Type: -

Identifier Source: org_study_id

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