Clinical trial · Observational
Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma
NCT02823327CI-TRIAL-00089512terminatedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AIDS-Related Primary Effusion Lymphoma | AIDS-Related Primary Effusion Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Genetic | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Genetic: Laboratory Biomarker Analysis
- Other: Medical Chart Review
Primary outcomes (3)
- measure
- Differential Gene Expression Profile by RNA-Seq or GeneChip Assays
- timeFrame
- baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.