Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

AIDS Malignancy Consortium

Status: Terminated

Conditions: AIDS-Related Primary Effusion Lymphoma

Treatments: Genetic: Laboratory Biomarker Analysis; Other: Medical Chart Review

Study type: Observational

Funder types: Other; NETWORK; NIH

Identifiers

NCT02823327

U01CA121947 (U.S. NIH Grant/Contract)

S004 (Other Identifier)

AMC #S004 (Other Identifier)

AMC-S004 (Other Identifier)

NCI-2015-00794 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

21 participants in 1 patient group

Chart review, RNA sequencing, microarray

Description:

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.

Treatment:

Other: Medical Chart Review

Genetic: Laboratory Biomarker Analysis