Trial Outcomes & Findings for Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma (NCT NCT02823327)
NCT ID: NCT02823327
Last Updated: 2025-05-11
Results Overview
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.
TERMINATED
25 participants
baseline
2025-05-11
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Among 25 participants, there were 11 participants received KS treatment.
Baseline characteristics by cohort
| Measure |
Chart Review, RNA Sequencing, Microarray
n=25 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=25 Participants
|
|
Age, Continuous
|
54.7 years
n=25 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
|
HIV status
HIV positive
|
24 Participants
n=25 Participants
|
|
HIV status
HIV negative
|
1 Participants
n=25 Participants
|
|
HAART receipt at any time prior to PEL diagnosis
Yes
|
16 Participants
n=25 Participants
|
|
HAART receipt at any time prior to PEL diagnosis
No
|
8 Participants
n=25 Participants
|
|
HAART receipt at any time prior to PEL diagnosis
Unknown
|
1 Participants
n=25 Participants
|
|
HARRT at the time of PEL diagnosis
Yes
|
18 Participants
n=25 Participants
|
|
HARRT at the time of PEL diagnosis
No
|
6 Participants
n=25 Participants
|
|
HARRT at the time of PEL diagnosis
Unknown
|
1 Participants
n=25 Participants
|
|
History of Kaposi Sarcoma (KS)
Yes
|
11 Participants
n=25 Participants
|
|
History of Kaposi Sarcoma (KS)
No
|
13 Participants
n=25 Participants
|
|
History of Kaposi Sarcoma (KS)
Unknown
|
1 Participants
n=25 Participants
|
|
Prior treatment for KS
Yes
|
5 Participants
n=11 Participants • Among 25 participants, there were 11 participants received KS treatment.
|
|
Prior treatment for KS
No
|
6 Participants
n=11 Participants • Among 25 participants, there were 11 participants received KS treatment.
|
|
KS treatment within 1 month prior to PEL diagnosis
Yes
|
2 Participants
n=5 Participants • Among 11 participants received KS treatment, there were 5 participants received prior treatment.
|
|
KS treatment within 1 month prior to PEL diagnosis
No
|
3 Participants
n=5 Participants • Among 11 participants received KS treatment, there were 5 participants received prior treatment.
|
|
History of MCD
Yes
|
5 Participants
n=25 Participants
|
|
History of MCD
No
|
19 Participants
n=25 Participants
|
|
History of MCD
Unknown
|
1 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: RNAseq data were available from 20 participants among 25 participants.
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.
Outcome measures
| Measure |
Survival Less Than 2 Years With Available RNAseq Data
n=7 Participants
7 participants had RNAseq data among 8 participants with survival less than 2 years.
|
Survival More Than or Equal to 2 Years With Available RNAseq Data
n=13 Participants
13 participants had RNAseq data among 17 participants with survival more than or equal to 2 years.
|
|---|---|---|
|
Differential Gene Expression Profile by RNA-Seq or GeneChip Assays
|
4 Number of overexpressed genes
|
15 Number of overexpressed genes
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Response rates for the first line of therapy were estimated by survival status.
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.
Outcome measures
| Measure |
Survival Less Than 2 Years With Available RNAseq Data
n=8 Participants
7 participants had RNAseq data among 8 participants with survival less than 2 years.
|
Survival More Than or Equal to 2 Years With Available RNAseq Data
n=17 Participants
13 participants had RNAseq data among 17 participants with survival more than or equal to 2 years.
|
|---|---|---|
|
Response Rates
Complete response
|
1 Participants
|
13 Participants
|
|
Response Rates
Partial response
|
2 Participants
|
2 Participants
|
|
Response Rates
Stable disease
|
2 Participants
|
2 Participants
|
|
Response Rates
Progression
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: At 2 years post diagnosisPopulation: There are 8 participants with survival less than 2 years and 17 participants with survival more than or equal to 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.
Outcome measures
| Measure |
Survival Less Than 2 Years With Available RNAseq Data
n=8 Participants
7 participants had RNAseq data among 8 participants with survival less than 2 years.
|
Survival More Than or Equal to 2 Years With Available RNAseq Data
n=17 Participants
13 participants had RNAseq data among 17 participants with survival more than or equal to 2 years.
|
|---|---|---|
|
Survival Status at 2 Years
Hispanic
|
2 participants
|
5 participants
|
|
Survival Status at 2 Years
Non-EPOCH treatment
|
4 participants
|
4 participants
|
|
Survival Status at 2 Years
Stage I-III
|
2 participants
|
6 participants
|
|
Survival Status at 2 Years
Stage IV
|
6 participants
|
11 participants
|
|
Survival Status at 2 Years
Non-Hispanic
|
6 participants
|
12 participants
|
|
Survival Status at 2 Years
White
|
5 participants
|
9 participants
|
|
Survival Status at 2 Years
Non-White
|
3 participants
|
8 participants
|
|
Survival Status at 2 Years
EPOCH treatment
|
4 participants
|
13 participants
|
Adverse Events
Chart Review, RNA Sequencing, Microarray
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Deukwoo Kwon
Statistical and Data Analysis Center, AIDS Malignancy Consortium
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place