AIDS-Related Primary Effusion Lymphoma
Conditions
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.
Interventions
GENETICLaboratory Biomarker Analysis
Correlative studies
OTHERMedical Chart Review
Medical chart review is performed
Sponsors
National Cancer Institute (NCI)
University of California, San Diego
University of Arkansas
AIDS Malignancy Consortium
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differential Gene Expression Profile by RNA-Seq or GeneChip Assays | baseline | 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. |
| Response Rates | Up to 1 year | 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. |
| Survival Status at 2 Years | At 2 years post diagnosis | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Laboratory Biomarker Analysis: Correlative studies
Medical Chart Review: Medical chart review is performed | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Chart Review, RNA Sequencing, Microarray |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Age, Continuous | 54.7 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| HAART receipt at any time prior to PEL diagnosis No | 8 Participants |
| HAART receipt at any time prior to PEL diagnosis Unknown | 1 Participants |
| HAART receipt at any time prior to PEL diagnosis Yes | 16 Participants |
| HARRT at the time of PEL diagnosis No | 6 Participants |
| HARRT at the time of PEL diagnosis Unknown | 1 Participants |
| HARRT at the time of PEL diagnosis Yes | 18 Participants |
| History of Kaposi Sarcoma (KS) No | 13 Participants |
| History of Kaposi Sarcoma (KS) Unknown | 1 Participants |
| History of Kaposi Sarcoma (KS) Yes | 11 Participants |
| History of MCD No | 19 Participants |
| History of MCD Unknown | 1 Participants |
| History of MCD Yes | 5 Participants |
| HIV status HIV negative | 1 Participants |
| HIV status HIV positive | 24 Participants |
| KS treatment within 1 month prior to PEL diagnosis No | 3 Participants |
| KS treatment within 1 month prior to PEL diagnosis Yes | 2 Participants |
| Prior treatment for KS No | 6 Participants |
| Prior treatment for KS Yes | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: baseline
Population: RNAseq data were available from 20 participants among 25 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Survival Less Than 2 Years With Available RNAseq Data | Differential Gene Expression Profile by RNA-Seq or GeneChip Assays | 4 Number of overexpressed genes |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Differential Gene Expression Profile by RNA-Seq or GeneChip Assays | 15 Number of overexpressed genes |
Primary
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.
Time frame: Up to 1 year
Population: Response rates for the first line of therapy were estimated by survival status.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Survival Less Than 2 Years With Available RNAseq Data | Response Rates | Stable disease | 2 Participants |
| Survival Less Than 2 Years With Available RNAseq Data | Response Rates | Complete response | 1 Participants |
| Survival Less Than 2 Years With Available RNAseq Data | Response Rates | Progression | 3 Participants |
| Survival Less Than 2 Years With Available RNAseq Data | Response Rates | Partial response | 2 Participants |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Response Rates | Progression | 3 Participants |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Response Rates | Complete response | 13 Participants |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Response Rates | Stable disease | 2 Participants |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Response Rates | Partial response | 2 Participants |
Primary
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.
Time frame: At 2 years post diagnosis
Population: There are 8 participants with survival less than 2 years and 17 participants with survival more than or equal to 2 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Survival Less Than 2 Years With Available RNAseq Data | Survival Status at 2 Years | Hispanic | 2 participants |
| Survival Less Than 2 Years With Available RNAseq Data | Survival Status at 2 Years | Non-Hispanic | 6 participants |
| Survival Less Than 2 Years With Available RNAseq Data | Survival Status at 2 Years | White | 5 participants |
| Survival Less Than 2 Years With Available RNAseq Data | Survival Status at 2 Years | Non-White | 3 participants |
| Survival Less Than 2 Years With Available RNAseq Data | Survival Status at 2 Years | EPOCH treatment | 4 participants |
| Survival Less Than 2 Years With Available RNAseq Data | Survival Status at 2 Years | Non-EPOCH treatment | 4 participants |
| Survival Less Than 2 Years With Available RNAseq Data | Survival Status at 2 Years | Stage I-III | 2 participants |
| Survival Less Than 2 Years With Available RNAseq Data | Survival Status at 2 Years | Stage IV | 6 participants |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Survival Status at 2 Years | Stage IV | 11 participants |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Survival Status at 2 Years | Hispanic | 5 participants |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Survival Status at 2 Years | EPOCH treatment | 13 participants |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Survival Status at 2 Years | Non-Hispanic | 12 participants |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Survival Status at 2 Years | Stage I-III | 6 participants |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Survival Status at 2 Years | White | 9 participants |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Survival Status at 2 Years | Non-EPOCH treatment | 4 participants |
| Survival More Than or Equal to 2 Years With Available RNAseq Data | Survival Status at 2 Years | Non-White | 8 participants |