Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

AIDS-Related Primary Effusion Lymphoma Clinical Trial

Official title:

Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02823327
• Other study ID #: AMC-S004
• Secondary ID: NCI-2015-00794AM
• Status: Terminated
• Start date: October 11, 2016
• Est. completion date: February 3, 2023

Study information

• Verified date: April 2023
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: February 3, 2023
• Est. primary completion date: February 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AIDS-Related Primary Effusion Lymphoma
• Lymphoma

Intervention

Genetic:
• Laboratory Biomarker Analysis
Correlative studies

Other:
• Medical Chart Review
Medical chart review is performed

Locations

Country	Name	City	State
United States	Stroger Hospital of Cook County	Chicago	Illinois
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	UCLA CARE Center	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Memorial Hospital West	Pembroke Pines	Florida
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI), University of Arkansas, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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