Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-06 @ 3:01 AM
Study NCT ID:
NCT00898157
Status:
COMPLETED
Last Update Posted:
2017-05-19
First Post:
2009-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ECOG-E4494T1 | None | None | View |