Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02823327|
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : March 30, 2021
|Condition or disease||Intervention/treatment|
|AIDS-Related Primary Effusion Lymphoma||Genetic: Laboratory Biomarker Analysis Other: Medical Chart Review|
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)
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.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma|
|Actual Study Start Date :||October 11, 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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.
Genetic: Laboratory Biomarker Analysis
Other: Medical Chart Review
Medical chart review is performed
Other Name: Chart Review
- Differential gene expression profile by RNA-Seq or GeneChip assays [ Time Frame: Up to 1 year ]Resultant data will be assessed for quality, normalized and then analyzed for differential gene expression. Standard algorithms will be used in both GeneSpring and Bioconductor for this purpose. In particular, the RNA-sequencing data will be analyzed by the differential expression sequencing algorithm in bioconductor1. 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.
- Response rates [ Time Frame: Up to 1 year ]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 [ Time Frame: At 2 years post diagnosis ]Survival will be estimated using the Kaplan Meier method and Cox proportional hazards model will be used to assess differences between treatment groups and categorical baseline variables.
Biospecimen Retention: Samples With DNA
Tissues slides for verification of pathological diagnosis of primary effusion lymphoma.
Paraffin embedded tissues or cytology block or frozen tissue specimen for genomic analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823327
|United States, California|
|UC San Diego Moores Cancer Center||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Erin G. Reid 858-822-6271 firstname.lastname@example.org|
|Contact: William Wachsman 858-552-8585 ext 2628 email@example.com|
|Principal Investigator: Erin G. Reid, MD|
|Sub-Investigator: William Wachsman, MD|
|UCLA CARE Center||Recruiting|
|Los Angeles, California, United States, 90025|
|Contact: Faith Landsman 310-557-9062 firstname.lastname@example.org|
|Principal Investigator: Ronald Mitsuyasu, MD|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Terry A Lynch 305-243-9448 email@example.com|
|Principal Investigator: Juan C Ramos, MD|
|United States, Illinois|
|Stroger Hospital of Cook County||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Paul Rubinstein 312-864-7277 firstname.lastname@example.org|
|Principal Investigator: Paul Rubinstein, MD|
|United States, Washington|
|Virginia Mason Medical Center||Recruiting|
|Seattle, Washington, United States, 98101|
|Contact: Rachel Dowty 206-342-6928 email@example.com|
|Principal Investigator: David Aboulafia, MD|
|Principal Investigator:||Erin Reid||AIDS Malignancy Consortium|