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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00794 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| AMC-S004 | Other Identifier | National Cancer Institute | |
| AMC #S004 | Other Identifier | AMC | |
| S004 | Other Identifier | AMC | |
| AMC-S004 | Other Identifier | AIDS Malignancy Consortium | |
| AMC-S004 | Other Identifier | CTEP | |
| U01CA121947 | U.S. NIH Grant/Contract | View source |
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Poor accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of California, San Diego | OTHER |
| University of Arkansas | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Genetic | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Differential Gene Expression Profile by RNA-Seq or GeneChip Assays | 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. | baseline |
| Response Rates | 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. | Up to 1 year |
| Survival Status at 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. | At 2 years post diagnosis |
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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:
The minimum data required to be able to include a subject for analysis of genomic prognostic factors are:
Exclusion Criteria:
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Participants diagnosed with primary effusion lymphoma (HIV seropositive or negative) on or after January 1, 1998 and on whom survival status at 2 years post diagnosis is available.
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| Name | Affiliation | Role |
|---|---|---|
| Erin Reid | AIDS Malignancy Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States | ||
| UCLA CARE Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Differential Gene Expression Profile by RNA-Seq or GeneChip Assays | 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. | RNAseq data were available from 20 participants among 25 participants. | Posted | Number | Number of overexpressed genes | baseline |
|
This study is a retrospective, chart-review study. The time frame for evaluating adverse event is not applicable.
This study is a retrospective, chart-review study. Death and Adverse Events were not assessed. The adverse event report is not relevant. Since this is not an interventional study, the adverse event report is not relevant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deukwoo Kwon | Statistical and Data Analysis Center, AIDS Malignancy Consortium | (713) 500-7964 | deukwoo.kwon@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2019 | Jan 29, 2024 | Prot_SAP_000.pdf |
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Tissues slides for verification of pathological diagnosis of primary effusion lymphoma.
Paraffin embedded tissues or cytology block or frozen tissue specimen for genomic analysis.
| Medical Chart Review |
| Other |
Medical chart review is performed |
|
|
| Los Angeles |
| California |
| 90025 |
| United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Memorial Hospital West | Pembroke Pines | Florida | 33028 | United States |
| Stroger Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| HIV status | Count of Participants | Participants |
|
| HAART receipt at any time prior to PEL diagnosis | Count of Participants | Participants |
|
| HARRT at the time of PEL diagnosis | Count of Participants | Participants |
|
| History of Kaposi Sarcoma (KS) | Count of Participants | Participants |
|
| Prior treatment for KS | Among 25 participants, there were 11 participants received KS treatment. | Count of Participants | Participants |
|
| KS treatment within 1 month prior to PEL diagnosis | Among 11 participants received KS treatment, there were 5 participants received prior treatment. | Count of Participants | Participants |
|
| History of MCD | Count of Participants | Participants |
|
7 participants had RNAseq data among 8 participants with survival less than 2 years. |
| OG001 | Survival More Than or Equal to 2 Years With Available RNAseq Data | 13 participants had RNAseq data among 17 participants with survival more than or equal to 2 years. |
|
|
| Primary | Response Rates | 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. | Response rates for the first line of therapy were estimated by survival status. | Posted | Count of Participants | Participants | Up to 1 year |
|
|
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| Primary | Survival Status at 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. | There are 8 participants with survival less than 2 years and 17 participants with survival more than or equal to 2 years. | Posted | Number | participants | At 2 years post diagnosis |
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| 0 |
| 0 |
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| Stable disease |
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| Progression |
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| White |
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| Non-White |
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| EPOCH treatment |
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| Non-EPOCH treatment |
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| Stage I-III |
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| Stage IV |
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