Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

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.

Study Overview

• Status: Terminated
• Conditions: AIDS-Related Primary Effusion Lymphoma
• Intervention / Treatment: Genetic: Laboratory Biomarker Analysis; Other: Medical Chart Review

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • UC San Diego Moores Cancer Center
    • Los Angeles, California, United States, 90025
      • UCLA CARE Center
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Pembroke Pines, Florida, United States, 33028
      • Memorial Hospital West
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Stroger Hospital of Cook County
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with primary effusion lymphoma (HIV seropositive or negative) on or after January 1, 1998 and on whom survival status at 2 years post diagnosis is available.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Genetic: Laboratory Biomarker Analysis; Correlative studies; Other: Medical Chart Review; Medical chart review is performed; Other Names: Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differential Gene Expression Profile by RNA-Seq or GeneChip Assays	The resultant data will be a subset of the whole analysis population due to RNAseq data availability. It will be assessed for quality, normalized, and then analyzed for differential gene expression. The Nanostring software nSolver will be used to do quality control, background subtraction, normalization, and analysis of the differential expression for RNA-sequencing data. 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. 19 Genes with p-value less than 0.05 were reported by the level of gene expression.	baseline
Response Rates	The number of participants for this outcome measure is 25 participants with baseline characteristics and response evaluation. Since this was a retrospective study, response criteria were not defined. Response determinations as recorded in the medical record by the treating physician were abstracted on each participant for data analysis. 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 Status at 2 Years	Survival duration will be determined using the elapsed time between the date of PEL diagnosis and the last follow-up date or the date of death.	At 2 years post diagnosis

Collaborators and Investigators

• Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI); University of California, San Diego; University of Arkansas
• Investigators: Principal Investigator: Erin Reid, AIDS Malignancy Consortium

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2016
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimated): July 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, Primary Effusion
• Other Study ID Numbers: AMC-S004 (Other Identifier: CTEP); U01CA121947 (U.S. NIH Grant/Contract); NCI-2015-00794 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); AMC #S004 (Other Identifier: AMC); S004 (Other Identifier: AMC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED