Ignite Creation Date:
2024-05-05 @ 11:40 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01381705
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2011-06-23
Brief Title:
Biomarkers in Predicting Response to Rituximab Treatment in Samples From Patients With Indolent Follicular Lymphoma
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Validating the Predictive Value of Response to Rituximab Induction and Maintenance of the FCGR3A 158VF 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 158VF in parallel to independently verify results
Correlate the FCGR3A 158VF 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 158VF 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 158VF in parallel to independently verify results
Correlate the FCGR3A 158VF 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 158VF polymorphisms using different complementary genotyping methods Assay results are reviewed and compared with patients outcome data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-E4402T2 | None | None | None |