Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

NCT02823327 | Terminated Results

• 5 other identifiers: AMC-S004NCI-2015-00794AMC #S004S004U01CA121947
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 6

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.

Conditions

AIDS-Related Primary Effusion Lymphoma

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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; Other: Medical Chart Review

Interventions

Laboratory Biomarker Analysis GENETIC

Correlative studies

Chart review, RNA sequencing, microarray

Medical Chart Review OTHER

Medical chart review is performed

Also known as: Chart Review

Chart review, RNA sequencing, microarray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients who do not fulfill the criteria as listed above are ineligible

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• University of California, San Diego: collaborator
• University of Arkansas: collaborator

Study Sites (6)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

UCLA CARE Center

Los Angeles, California, 90025, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Memorial Hospital West

Pembroke Pines, Florida, 33028, United States

Location

Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissues slides for verification of pathological diagnosis of primary effusion lymphoma. Paraffin embedded tissues or cytology block or frozen tissue specimen for genomic analysis.

Results Point of Contact

• Title: Deukwoo Kwon
• Organization: Statistical and Data Analysis Center, AIDS Malignancy Consortium

deukwoo.kwon@mountsinai.org

(713) 500-7964

Study Officials

• Erin Reid

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: July 6, 2016
• Study Start: October 11, 2016
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-05

Locations

US (6)