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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01131208
First received: May 25, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  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 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.


Condition Intervention
Lymphoma
Genetic: gene expression analysis
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Gene Expression Profiling Using Paraffin-embedded Tissues and the Nuclease Protection Assay in Diffuse Large B-cell Lymphoma (DLBCL) Treated With CHOP or R-CHOP: An ECOG and SWOG Correlative Study of E4494

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Identification of genes predictive of clinical outcome [ Designated as safety issue: No ]
  • Identification of genes that change their prognostic profile with the addition of rituximab to CHOP chemotherapy [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131208

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Jane N. Winter, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01131208     History of Changes
Other Study ID Numbers: CDR0000671515, ECOG-E4494T2
Study First Received: May 25, 2010
Last Updated: May 25, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
recurrent adult diffuse large cell lymphoma
stage I adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma

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

ClinicalTrials.gov processed this record on September 18, 2014