Evaluation of Serum Free Light Chains and Clonal Ig DNA in Plasma From Patients With Aggressive B-Cell Lymphomas
18 Years
N/A
Both
Lymphoma, Nonneoplastic Condition
Trial Information
Evaluation of Serum Free Light Chains and Clonal Ig DNA in Plasma From Patients With Aggressive B-Cell Lymphomas
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of an untreated aggressive B-cell lymphoma, including:
- Diffuse large B cell/immunoblastic lymphoma
- Burkitt lymphoma
- Hodgkin lymphoma
- Serological documentation of HIV infection by any of the FDA-approved tests
- Available diagnostic material from fresh frozen tissue or formalin-fixed paraffin
embedded tissue OR willing to undergo a repeat biopsy (fine needle aspiration is
acceptable)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC)
Outcome Time Frame:
Study entry
Safety Issue:
No
Principal Investigator
Nina Wagner-Johnston, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mallinckrodt Institute of Radiology at Washington University Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000648183
NCT ID:
NCT00981097
Start Date:
August 2009
Completion Date:
June 2013
Related Keywords:
- Lymphoma
- Nonneoplastic Condition
- HIV infection
- HIV-associated Hodgkin lymphoma
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- contiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- stage I adult Burkitt lymphoma
- stage III adult Burkitt lymphoma
- stage IV adult Burkitt lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage IV adult diffuse large cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- Hodgkin Disease
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large-Cell, Immunoblastic
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
| Montefiore Medical Center | Bronx, New York 10467-2490 |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| UCLA Clinical AIDS Research and Education (CARE) Center | Los Angeles, California 90024 |
| Boston University Cancer Research Center | Boston, Massachusetts 02118 |
| Mallinckrodt Institute of Radiology at Washington University Medical Center | St. Louis, Missouri 63110 |
| University of Miami | Miami, Florida 33136 |
| Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia | Philadelphia, Pennsylvania 19106 |
| Benaroya Research Institute at Virginia Mason Medical Center | Seattle, Washington 98101 |
| University of California at Davis Center for Aids Research and Education Services | Sacramento, California 95814 |
| Thomas Street Health Center | Houston, Texas 77009 |
| UNC Hospitals, The University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
