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
Recruitment status was Not yet recruiting
Sponsor:
Eastern Cooperative Oncology Group
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
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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) |
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 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 May 21, 2013