Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-11

Study Completion Date

2023-02-03

Brief Summary

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This research trial studies clinical factors and gene expression analysis for prognosis in tissue samples from patients with acquired immune deficiency syndrome (AIDS)-related primary effusion lymphoma. Gathering health information over time and studying samples of tissue from patients in the laboratory may help doctors learn about the prognosis of patients with AIDS-related primary effusion lymphoma.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Identify baseline clinical characteristics and treatment strategies in patients with AIDS-associated primary effusion lymphoma (PEL) that correlate with long-term survival (\>= 2 years). (Primary clinical objective) II. Identify differentially expressed genes in PEL that are associated with long-term survival (\>= 2 years). (Primary genomic objective)

OUTLINE:

Medical chart review is performed and patient information is collected regarding human immunodeficiency virus human immunodeficiency virus (HIV)/AIDS medical history, staging of AIDS related malignancy, and type of treatment. Previously collected tissue samples are analyzed via ribonucleic acid (RNA) sequencing and microarray.

Conditions

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AIDS-Related Primary Effusion Lymphoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Chart review, RNA sequencing, microarray

Laboratory Biomarker Analysis. Medical chart review is performed and patient information is collected regarding human immunodeficiency virus HIV/AIDS medical history, staging of AIDS related malignancy, and type of treatment. Previously collected tissue samples are analyzed via RNA sequencing and microarray.

Laboratory Biomarker Analysis

Intervention Type GENETIC

Correlative studies

Medical Chart Review

Intervention Type OTHER

Medical chart review is performed

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type GENETIC

Medical Chart Review

Medical chart review is performed

Intervention Type OTHER

Other Intervention Names

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Chart Review

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with primary effusion lymphoma (HIV seropositive or negative) on or after January 1, 1998 on whom survival status at 2 years post PEL diagnosis is available
* Participants may be enrolled to either or both the clinical or genomic portions of the study
* The minimum data required to be able to include a subject for analysis of clinical prognostic factors are:

* HIV status, and for HIV subjects include cluster of differentiation (CD)4 count, HIV viral load closest to time of diagnosis
* Age at PEL diagnosis
* Gender
* Stage at diagnosis
* Treatment of PEL
* Response to treatment
* Survival status at 2 years
* Pathology slides (or paraffin block) for central review
* The minimum data required to be able to include a subject for analysis of genomic prognostic factors are:

* Availability of a pathologic specimen of PEL that will be submitted for genomic analysis
* Survival status at 2 years

Exclusion Criteria

* Patients who do not fulfill the criteria as listed above are ineligible

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Reid

Role: PRINCIPAL_INVESTIGATOR

AIDS Malignancy Consortium

Locations

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UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

UCLA CARE Center

Los Angeles, California, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Memorial Hospital West

Pembroke Pines, Florida, United States

Site Status

Stroger Hospital of Cook County

Chicago, Illinois, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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