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Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

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ClinicalTrials.gov Identifier: NCT02823327
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : March 30, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of California, San Diego
University of Arkansas
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Tracking Information
First Submitted Date July 1, 2016
First Posted Date July 6, 2016
Last Update Posted Date March 30, 2021
Actual Study Start Date October 11, 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2016)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma
Official Title Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma
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.
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 Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

Tissues slides for verification of pathological diagnosis of primary effusion lymphoma.

Paraffin embedded tissues or cytology block or frozen tissue specimen for genomic analysis.

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.
Condition AIDS-Related Primary Effusion Lymphoma
Intervention
  • Genetic: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Medical Chart Review
    Medical chart review is performed
    Other Name: Chart Review
Study Groups/Cohorts 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.
Interventions:
  • Genetic: Laboratory Biomarker Analysis
  • Other: Medical Chart Review
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 1, 2016)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02823327
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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AIDS Malignancy Consortium
Study Sponsor AIDS Malignancy Consortium
Collaborators
  • National Cancer Institute (NCI)
  • University of California, San Diego
  • University of Arkansas
Investigators
Principal Investigator: Erin Reid AIDS Malignancy Consortium
PRS Account AIDS Malignancy Consortium
Verification Date March 2021