- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02823327
Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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La Jolla, California, United States, 92093
- UC San Diego Moores Cancer Center
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Los Angeles, California, United States, 90025
- UCLA CARE Center
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Pembroke Pines, Florida, United States, 33028
- Memorial Hospital West
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Illinois
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Chicago, Illinois, United States, 60612
- Stroger Hospital of Cook County
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Washington
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Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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Correlative studies
Medical chart review is performed
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differential gene expression profile by RNA-Seq or GeneChip assays
Time Frame: Up to 1 year
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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.
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Up to 1 year
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Response rates
Time Frame: Up to 1 year
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Response rates will be reported with 95% confidence intervals (binomial distribution).
Descriptive statistics will be used to summarize baseline clinical, histological, and viral characteristics.
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Up to 1 year
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Survival
Time Frame: At 2 years post diagnosis
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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.
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At 2 years post diagnosis
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Erin Reid, AIDS Malignancy Consortium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMC-S004 (Other Identifier: CTEP)
- U01CA121947 (U.S. NIH Grant/Contract)
- NCI-2015-00794 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- AMC #S004 (Other Identifier: AMC)
- S004 (Other Identifier: AMC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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