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

A

AIDS Malignancy Consortium

Status

Completed

Conditions

Nonneoplastic Condition
Lymphoma

Treatments

Genetic: polymerase chain reaction
Other: laboratory biomarker analysis

Study type

Observational

Funder types

NETWORK
Industry
NIH

Identifiers

NCT00981097
U01CA121947 (U.S. NIH Grant/Contract)
AMC-064
CDR0000648183 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

52 participants in 1 patient group

Specimen Collection
Description:
Subjects with a diagnosis of HIV and an untreated aggressive B-cell lymphoma.
Treatment:
Genetic: polymerase chain reaction
Other: laboratory biomarker analysis

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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