Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT01381705
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2011-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers in Predicting Response to Rituximab Treatment in Samples From Patients With Indolent Follicular Lymphoma
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Study Overview
Official Title:
Validating the Predictive Value (of Response to Rituximab Induction and Maintenance) of the FCGR3A 158V/F Polymorphism Using Complimentary Genotyping Methods
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 blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify 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 predicting response to rituximab treatment in samples from patients with indolent follicular lymphoma.
PURPOSE: This research study is studying biomarkers in predicting response to rituximab treatment in samples from patients with indolent follicular lymphoma.
Detailed Description:
OBJECTIVES:
Primary
* Genotype the full cohort of samples available from the RESORT clinical trial (ECOG-E4402) for FCGR3A 158V/F in parallel to independently verify results.
* Correlate the FCGR3A 158V/F polymorphisms to response, response duration, and time to rituximab resistance.
Secondary
* Quantify copy number variation in FCGR3A in this cohort.
OUTLINE: Archived DNA samples isolate from peripheral blood mononuclear cells and from formalin-fixed paraffin-embedded tissue samples are analyzed for FCGR3A 158V/F polymorphisms using different complementary genotyping methods. Assay results are reviewed and compared with patients' outcome data.
Primary
* Genotype the full cohort of samples available from the RESORT clinical trial (ECOG-E4402) for FCGR3A 158V/F in parallel to independently verify results.
* Correlate the FCGR3A 158V/F polymorphisms to response, response duration, and time to rituximab resistance.
Secondary
* Quantify copy number variation in FCGR3A in this cohort.
OUTLINE: Archived DNA samples isolate from peripheral blood mononuclear cells and from formalin-fixed paraffin-embedded tissue samples are analyzed for FCGR3A 158V/F polymorphisms using different complementary genotyping methods. Assay results are reviewed and compared with patients' outcome data.
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-E4402T2 | None | None | View |