Study of Blood and Tissue Samples From Patients With Aggressive Non-Hodgkin B-Cell Lymphoma or Hodgkin Lymphoma
NCT ID: NCT00981097
Last Updated: 2020-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2009-08-31
2013-06-30
Brief Summary
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PURPOSE: This research study is looking at blood and tissue samples from patients with aggressive non-Hodgkin B-cell lymphoma or Hodgkin lymphoma.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Specimen Collection
Subjects with a diagnosis of HIV and an untreated aggressive B-cell lymphoma.
polymerase chain reaction
determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor
laboratory biomarker analysis
determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor
Interventions
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polymerase chain reaction
determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor
laboratory biomarker analysis
determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Emmes Company, LLC
INDUSTRY
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Principal Investigators
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Nina Wagner-Johnston, MD
Role: PRINCIPAL_INVESTIGATOR
Mallinckrodt Institute of Radiology at Washington University Medical Center
Locations
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Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States
University of California at Davis Center for Aids Research and Education Services
Sacramento, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Mallinckrodt Institute of Radiology at Washington University Medical Center
St Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
Philadelphia, Pennsylvania, United States
Thomas Street Health Center
Houston, Texas, United States
Baylor University Medical Center - Houston
Houston, Texas, United States
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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References
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Wagner-Johnston ND, Lensing S, Noy A, Ratner L, Henry D, Lee JY, Silver S, Faham M, Ambinder RF. High frequency of identical clonal immunoglobulin DNA in pre-treatment tumor and plasma from untreated patients with HIV-associated lymphoma: prospective multicenter trial of the AIDS malignancies consortium (AMC 064). Leuk Lymphoma. 2017 Dec;58(12):2939-2942. doi: 10.1080/10428194.2017.1317095. Epub 2017 May 16.
Other Identifiers
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CDR0000648183
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-064
Identifier Type: -
Identifier Source: org_study_id
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