AIDS-Related Primary Effusion LymphomaNCT02823327
Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma
An observational study of AIDS-Related Primary Effusion Lymphoma, run by AIDS Malignancy Consortium at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS-Related Primary Effusion Lymphoma
- What is being tested?
- Laboratory Biomarker Analysis and Medical Chart Review
- How many people
- 25 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 Oct 2016to 3 Feb 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- Patients who do not fulfill the criteria as listed above are ineligible
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Stroger Hospital of Cook County
Chicago, Illinois, 60612
UC San Diego Moores Cancer Center
La Jolla, California, 92093
UCLA CARE Center
Los Angeles, California, 90025
University of Miami
Miami, Florida, 33136
Memorial Hospital West
Pembroke Pines, Florida, 33028
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- AIDS-Related Primary Effusion Lymphoma
- Being tested
- Laboratory Biomarker Analysis, Medical Chart Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisGenetic
Correlative studies
Medical Chart ReviewOther
Also called Chart Review
Medical chart review is performed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: Laboratory Biomarker Analysis; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At 2 years post diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start11 Oct 2016
- Primary completion3 Feb 2023
- Study completion3 Feb 2023
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AIDS-Related Primary Effusion LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), University of California, San Diego, University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Erin Reid, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823327
- Sponsor's protocol ID
- AMC-S004
- Other IDs
- NCI-2015-00794, AMC-S004, AMC #S004, S004, AMC-S004, AMC-S004, U01CA121947
- Status last verified
- May 2025
- First submitted
- 1 Jul 2016
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma
- ClinicalTrials.gov ID
- NCT02823327
- Acronym / sponsor ID
- AMC-S004
- Conditions
- AIDS-Related Primary Effusion Lymphoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI), University of California, San Diego, University of Arkansas
- Study start
- 11 Oct 2016 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chart review, RNA sequencing, microarray | – | Genetic: Laboratory Biomarker Analysis, Other: Medical Chart ReviewLaboratory 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (1 listed)
- Patients who do not fulfill the criteria as listed above are ineligible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Genetic | Chart review, RNA sequencing, microarray |
| Medical Chart ReviewAlso: Chart ReviewMedical chart review is performed | Other | Chart review, RNA sequencing, microarray |
Primary outcome
Differential Gene Expression Profile by RNA-Seq or GeneChip Assays
Time frame: baseline
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.
Response Rates
Time frame: Up to 1 year
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.
Survival Status at 2 Years
Time frame: At 2 years post diagnosis
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin Reid principal investigator
AIDS Malignancy Consortium
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AIDS-Related Primary Effusion Lymphoma, run by AIDS Malignancy Consortium at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential Gene Expression Profile by RNA-Seq or GeneChip Assays (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.