Biomarkers in Patients With Stage III or Stage IV Follicular Lymphoma Treated on Clinical Trial E-1496

Lymphoma Clinical Trial

Official title:

Identification of Biomarkers in Follicular Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898963
• Other study ID #: CDR0000544400
• Secondary ID: ECOG-E1496T1
• Status: Completed
• Start date: April 18, 2007
• Est. completion date: February 11, 2011

Study information

• Verified date: July 2020
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 predict how patients respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers in patients with stage III or stage IV follicular lymphoma treated on clinical trial E-1496.

Description:

OBJECTIVES:

• Correlate gene expression profiles with progression-free survival (PFS) of patients with stage III or IV follicular lymphoma treated with cyclophosphamide, vincristine, and prednisone with or without rituximab on clinical trial E-1496.

• Determine if immunoglobulin Fc-gamma receptor polymorphisms are predictive of PFS in these patients.

• Assess the significance of the microenvironment by constructing tissue microarrays of follicular lymphoma and immunostaining with relevant biomarkers.

• Correlate relevant biomarkers with clinical features, response, and PFS.

OUTLINE: This is a multicenter study.

Tissue samples are analyzed by gene expression profiling, microarrays to predict gene expression, immunohistochemistry, and immunoglobulin Fc-gamma receptor polymorphism analysis for biological markers.

PROJECTED ACCRUAL: A total of 175 samples will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: February 11, 2011
• Est. primary completion date: February 11, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of follicular lymphoma

• Stage III or IV disease

• Received cyclophosphamide, vincristine, and prednisone with or without rituximab on clinical trial E-1496

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Genetic:
• gene expression analysis

• microarray analysis

• polymorphism analysis

Other:
• diagnostic laboratory biomarker analysis

• immunohistochemistry staining method

• immunologic technique

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of gene expression profiles with progression-free survival (PFS)		1 month
Primary	Prediction of PFS by immunoglobulin Fc-gamma receptor polymorphisms as assessed by immunohistochemistry		1 month
Primary	Assessment of significance of microenvironment by constructing tissue microarrays and immunostaining with relevant biomarkers		1 month
Primary	Correlation of relevant biomarkers with clinical features, response, and PFS		1 month