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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00981097
Other study ID # AMC-064
Secondary ID U01CA121947CDR00
Status Completed
Phase
First received
Last updated
Start date August 2009
Est. completion date June 2013

Study information

Verified date August 2020
Source AIDS Malignancy Consortium
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 52
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States Boston University Cancer Research Center Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States UNC Hospitals, The University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Baylor University Medical Center - Houston Houston Texas
United States Thomas Street Health Center Houston Texas
United States 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 Miami Miami Florida
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia Philadelphia Pennsylvania
United States University of California at Davis Center for Aids Research and Education Services Sacramento 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 UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California
United States Benaroya Research Institute at Virginia Mason Medical Center Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
AIDS Malignancy Consortium National Cancer Institute (NCI), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with diffuse large B-cell/immunoblastic and Burkitt histologies with elevated serum free light chains (FLC) Study entry
Primary Proportion of patients with Hodgkin lymphoma clonal immunoglobulin (Ig) DNA detection in the plasma Study entry
Secondary Agreement between the detection of a monoclonal Ig DNA spike in plasma and the detection of a monoclonal DNA spike in tumor tissue Study entry
Secondary Agreement between the fragment length of a spike in tumor tissue and the fragment length of the spike in plasma Study entry
Secondary Detection rate of elevated FLC in each histology, including diffuse large B-cell/immunoblastic and Burkitt lymphoma Study entry
Secondary Detection rate of clonal Ig DNA in each histology, including diffuse large B-cell/immunoblastic, Burkitt lymphoma, and Hodgkin lymphoma Study entry
Secondary 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 Study entry
Secondary Detection rate of clonotypic B cells in peripheral blood mononuclear cells from patients with Hodgkin lymphoma Study entry
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