Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
RATIONALE: Collecting and studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research trial studies collecting tissue samples from patients with HIV-related malignancies.
Genetic: DNA analysis
Genetic: RNA analysis
Genetic: gene expression analysis
Genetic: polymorphism analysis
Other: biologic sample preservation procedure
Other: flow cytometry
Other: laboratory biomarker analysis
Other: medical chart review
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Tissue Acquisition for Analysis of Prognostic Factors, Immunology, and Genetic Progression of HIV-1 Associated Malignancies|
- Mutational spectrum of each type of HIV-1 associated malignancy [ Time Frame: Study entry (prior to chemotherapy initiation) ] [ Designated as safety issue: No ]Complete genomic sequencing of HIV-1 associated tumor tissue
Biospecimen Retention: Samples With DNA
Fresh-frozen tissue, Peripheral blood mononuclear cells
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
- To obtain high-quality, clinically annotated tissue from patients with human immunodeficiency virus (HIV)-1 malignancy.
- To study clinical, genetic, and immunologic parameters that have prognostic significance and/or are involved in the initiation and progression of HIV-1 malignancies, including complete genomic sequence determination of HIV-associated diffuse large B-cell lymphomas, lung cancer, anal cancer, and cervical cancer.
OUTLINE: This is a multicenter study.
Patients undergo tumor, lymph node, bone marrow, or skin biopsy, and peripheral blood mononuclear cells collection. Samples are submitted to the AIDS Malignancy Consortium (AMC) Biorepository and transferred to the AIDS and Cancer Specimen Resource (ACSR). Samples are then analyzed by the Genome Science Center of British Columbia (GSC-BC) and the HIV+ Tumor Molecular Characterization Project (HTMCP) for full genomic sequencing analysis that may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies by flow cytometry, cytogenetics, and molecular studies. Patients' clinical data, demographics, and treatment given are also collected prospectively in order to record treatment outcome and toxicity.
Patients are followed up at 6 months, 1 year, and 2 years for data-reporting purposes.
|United States, California|
|UCLA Clinical AIDS Research and Education (CARE) Center||Recruiting|
|Los Angeles, California, United States, 90095-1793|
|Contact: Ronald Mitsuyasu, MD 310-557-9680|
|Principal Investigator: Ronald Mitsuyasu, MD|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Juan Carlos Ramos, MD 305-243-6611|
|Principal Investigator: Juan Carlos Ramos, MD|
|United States, Hawaii|
|Cancer Research Center of Hawaii||Recruiting|
|Honolulu, Hawaii, United States, 96813|
|Contact: Bruce Shiramizu, MD 808-737-2751|
|United States, Missouri|
|AIDS Associated Malignancies Clinical Trials Consortium||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Lee Ratner, MD, PhD 314-362-8836 email@example.com|
|United States, New York|
|Albert Einstein Cancer Center at Albert Einstein College of Medicine||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 firstname.lastname@example.org|
|Principal Investigator: Missak Haigentz, MD|
|Principal Investigator:||Lee Ratner, MD, PhD||Washington University Siteman Cancer Center|