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Study of Blood and Tissue Samples From Patients With Aggressive Non-Hodgkin B-Cell Lymphoma or Hodgkin Lymphoma

Completed
Conditions
Lymphoma
Nonneoplastic Condition
Interventions
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis
Registration Number
NCT00981097
Lead Sponsor
AIDS Malignancy Consortium
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
52
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Specimen Collectionlaboratory biomarker analysisSubjects with a diagnosis of HIV and an untreated aggressive B-cell lymphoma.
Specimen Collectionpolymerase chain reactionSubjects with a diagnosis of HIV and an untreated aggressive B-cell lymphoma.
Primary Outcome Measures
NameTimeMethod
Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasmaStudy entry
Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC)Study entry
Secondary Outcome Measures
NameTimeMethod
Detection rate of clonotypic B cells in peripheral blood mononuclear cells from patients with Hodgkin lymphomaStudy entry
Analysis of the clinical and pathologic correlates of detection by the serum/plasma tests: disease subtype, stage of disease, disease bulk, lactate dehydrogenase, and Ki67 indexStudy entry
Detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphomaStudy entry
Agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissueStudy entry
Agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasmaStudy entry
Detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphomaStudy entry

Trial Locations

Locations (16)

Boston University Cancer Research Center

🇺🇸

Boston, Massachusetts, United States

Thomas Street Health Center

🇺🇸

Houston, Texas, United States

Benaroya Research Institute at Virginia Mason Medical Center

🇺🇸

Seattle, Washington, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

🇺🇸

Baltimore, Maryland, United States

Rebecca and John Moores UCSD Cancer Center

🇺🇸

La Jolla, California, United States

Mallinckrodt Institute of Radiology at Washington University Medical Center

🇺🇸

Saint Louis, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

🇺🇸

Saint Louis, Missouri, United States

UNC Hospitals, The University of North Carolina at Chapel Hill

🇺🇸

Chapel Hill, North Carolina, United States

Memorial Sloan-Kettering Cancer Center

🇺🇸

New York, New York, United States

UCLA Clinical AIDS Research and Education (CARE) Center

🇺🇸

Los Angeles, California, United States

Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

University of Miami

🇺🇸

Miami, Florida, United States

Baylor University Medical Center - Houston

🇺🇸

Houston, Texas, United States

UCSF Helen Diller Family Comprehensive Cancer Center

🇺🇸

San Francisco, California, United States

University of California at Davis Center for Aids Research and Education Services

🇺🇸

Sacramento, California, United States

Montefiore Medical Center

🇺🇸

Bronx, New York, United States

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