Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Differential Gene Expression Profile by RNA-Seq or GeneChip Assays
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •Patients who do not fulfill the criteria as listed above are ineligible
结局指标
主要结局
Differential Gene Expression Profile by RNA-Seq or GeneChip Assays
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点