Clinical trial NCT02823327: Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma
Official title: Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: AIDS-Related Primary Effusion Lymphoma
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: University of California, San Diego
name: University of Arkansas
First posted: 2016-07-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Differential Gene Expression Profile by RNA-Seq or GeneChip Assays
timeFrame: baseline
measure: Response Rates
timeFrame: Up to 1 year
measure: Survival Status at 2 Years
timeFrame: At 2 years post diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA CARE Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Hospital West
state: Florida
city: Chicago
country: United States
facility: Stroger Hospital of Cook County
state: Illinois
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: AIDS Malignancy Consortium
name: Erin Reid
role: PRINCIPAL_INVESTIGATOR
References: