Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

April 12, 2023 updated by: AIDS Malignancy Consortium
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

Intervention / Treatment

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)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
Up to 1 year
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.
Up to 1 year
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.
At 2 years post diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimate)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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