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Clinical Factors and Gene Expression Analysis for Prognosis in Tissue Samples From Patients With AIDS-Related Primary Effusion Lymphoma

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ClinicalTrials.gov Identifier: NCT02823327
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of California, San Diego
University of Arkansas
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Brief Summary:
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.

Condition or disease Intervention/treatment
AIDS-Related Primary Effusion Lymphoma Genetic: Laboratory Biomarker Analysis Other: Medical Chart Review

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.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019


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.
Genetic: Laboratory Biomarker Analysis
Correlative studies

Other: Medical Chart Review
Medical chart review is performed
Other Name: Chart Review




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Erin G. Reid    858-822-6271    egreid@ucsd.edu   
Contact: William Wachsman    858-552-8585 ext 2628    wwachsman@ucsd.edu   
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    careoutreach@mednet.ucla.edu   
Principal Investigator: Ronald Mitsuyasu, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Terry A Lynch    305-243-9448    tlynch@miami.edu   
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    prubinstein@cookcountyhhs.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    rachel.dowty@virginiamason.org   
Principal Investigator: David Aboulafia, MD         
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
University of California, San Diego
University of Arkansas
Investigators
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Principal Investigator: Erin Reid AIDS Malignancy Consortium

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Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT02823327     History of Changes
Other Study ID Numbers: AMC-S004
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 )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Primary Effusion
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin