Clinical Trial: Clinical Factors and Gene Expression Analysis for Prognosis in Tissue Samples From Patients With AIDS-Related Primary Effusion Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary: 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 Summary:

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.

Current Primary Outcome:

• Differential gene expression profile by RNA-Seq or GeneChip assays [ Time Frame: Up to 1 year ]
  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.
• Response rates [ Time Frame: Up to 1 year ]
  Response rates will be reported with 95% confidence intervals (binomial distribution). Descriptive statistics will be used to summarize baseline clinical, histological, and viral characteristics.
• Survival [ Time Frame: At 2 years post diagnosis ]
  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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: AIDS Malignancy Consortium

Dates:
Date Received: July 1, 2016
Date Started: March 2016
Date Completion: March 2018
Last Updated: April 19, 2017
Last Verified: April 2017