Lymphoma Clinical Trial
Official title:
Evaluation of Serum Free Light Chains and Clonal Ig DNA in Plasma From Patients With Aggressive B-Cell Lymphomas
RATIONALE: Studying samples of blood and 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.
PURPOSE: This research study is looking at blood and tissue samples from patients with
aggressive non-Hodgkin B-cell lymphoma or Hodgkin lymphoma.
OBJECTIVES:
Primary
- To estimate the proportion of patients with diffuse large B-cell/immunoblastic and
Burkitt histologies with elevated serum free light chains (FLC).
- To estimate the proportion of patients with Hodgkin lymphoma with clonal immunoglobulin
(Ig) DNA detection in the plasma.
Secondary
- To estimate the agreement between the detection of a monoclonal Ig DNA spike in plasma
and the detection of a monoclonal DNA spike in tumor tissue.
- To estimate the agreement between the fragment length of a spike in tumor tissue and the
fragment length of the spike in plasma.
- To estimate the detection rate of elevated FLC in each histology, including diffuse
large B-cell/immunoblastic and Burkitt lymphoma.
- To estimate the detection rate of clonal Ig DNA in each histology, including diffuse
large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma.
- To analyze clinical and pathologic correlates of detection by the serum/plasma tests:
disease subtype, stage of disease, disease bulk, lactate dehydrogenase, and Ki-67 index.
- To estimate the detection rate of clonotypic B-cells in peripheral blood mononuclear
cells from patients with Hodgkin lymphoma.
OUTLINE: This is a multicenter study.
Blood and tissue samples collected at the time of diagnosis are analyzed for serum free light
chain and clonal immunoglobulin (Ig) DNA rearrangements and circulating clonotypic B-cells
via PCR.
PROJECTED ACCRUAL: A total of 50 patients (25 with diffuse large B-cell/immunoblastic
histologies, 15 with Burkitt lymphoma, and 10 with Hodgkin lymphoma) will be accrued for this
study.
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