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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00981097
First received: September 19, 2009
Last updated: June 5, 2013
Last verified: June 2013

September 19, 2009
June 5, 2013
August 2009
June 2013   (final data collection date for primary outcome measure)
  • Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC) [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasma [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC) [ Designated as safety issue: No ]
  • Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasma [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00981097 on ClinicalTrials.gov Archive Site
  • Agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • 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 index [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Detection rate of clonotypic B cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue [ Designated as safety issue: No ]
  • Agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma [ Designated as safety issue: No ]
  • Detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma [ Designated as safety issue: No ]
  • Detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma [ Designated as safety issue: No ]
  • 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 index [ Designated as safety issue: No ]
  • Detection rate of clonotypic B cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Blood and Tissue Samples From Patients With Aggressive Non-Hodgkin B-Cell Lymphoma or Hodgkin Lymphoma
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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

5 tubes of peripheral blood collected along with available tissue blocks or fresh frozen tissue collected at baseline.

Non-Probability Sample

Persons with HIV infection and a diagnosis of an untreated aggressive B-cell lymphoma.

  • Lymphoma
  • Nonneoplastic Condition
  • Genetic: polymerase chain reaction
    determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor
  • Other: laboratory biomarker analysis
    determination of elevated serum FLC and clonal Ig detection rates in plasma and tumor
Specimen Collection
Subjects with a diagnosis of HIV and an untreated aggressive B-cell lymphoma.
Interventions:
  • Genetic: polymerase chain reaction
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00981097
CDR0000648183, U01CA121947, AMC-064
No
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
National Cancer Institute (NCI)
Principal Investigator: Nina Wagner-Johnston, MD Mallinckrodt Institute of Radiology at Washington University Medical Center
AIDS Malignancy Clinical Trials Consortium
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP