Clinical trial

Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

Name
AMC-S004
Description
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.
Trial arms
Trial start
2016-10-11
Estimated PCD
2023-02-03
Trial end
2023-02-03
Status
Terminated
Treatment
Laboratory Biomarker Analysis
Correlative studies
Arms:
Chart review, RNA sequencing, microarray
Medical Chart Review
Medical chart review is performed
Arms:
Chart review, RNA sequencing, microarray
Other names:
Chart Review
Size
21
Primary endpoint
Differential gene expression profile by RNA-Seq or GeneChip assays
Up to 1 year
Response rates
Up to 1 year
Survival
At 2 years post diagnosis
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
Protocol
{'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissues slides for verification of pathological diagnosis of primary effusion lymphoma.\n\nParaffin embedded tissues or cytology block or frozen tissue specimen for genomic analysis.'}, 'enrollmentInfo': {'count': 21, 'type': 'ACTUAL'}}
Updated at
2023-04-14

1 organization

1 product

1 indication