Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

Study Overview
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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.

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.

Official Title
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Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

Conditions
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AIDS-Related Primary Effusion Lymphoma

Intervention / Treatment
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* Genetic: Laboratory Biomarker Analysis
* Other: Medical Chart Review


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chart review, RNA sequencing, microarray<br>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. | Genetic: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Medical Chart Review<br>* Medical chart review is performed<br>* Other names: Chart Review;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential gene expression profile by RNA-Seq or GeneChip assays | Resultant data will be assessed for quality, normalized and then analyzed for differential gene expression. Standard algorithms will be used in both GeneSpring and Bioconductor for this purpose. In particular, the RNA-sequencing data will be analyzed by the differential expression sequencing algorithm in bioconductor1. Lastly, bioinformatic analysis approaches will be used to help make sense of possible biological links between the genes found to be differentially expressed between the sample groups that may be of prognostic significance. | Up to 1 year | 
| Response rates | Response rates will be reported with 95% confidence intervals (binomial distribution). Descriptive statistics will be used to summarize baseline clinical, histological, and viral characteristics. | Up to 1 year | 
| Survival | Survival will be estimated using the Kaplan Meier method and Cox proportional hazards model will be used to assess differences between treatment groups and categorical baseline variables. | At 2 years post diagnosis |