NCT01567722

Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies

Tissue Acquisition for Analysis of Prognostic Factors, Immunology, and Genetic Progression of HIV-1 Associated Malignancies

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 114 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lung Cancer
• Lymphoma

Interventions

Type	Name	Description
GENETIC	DNA analysis	This sample will be used for germline DNA analysis.
GENETIC	RNA analysis	RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.
GENETIC	gene expression analysis	Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
GENETIC	polymorphism analysis	Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
OTHER	biologic sample preservation procedure	Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
OTHER	flow cytometry	Information will include HIV RNA load at time of malignancy diagnosis) and imaging tests, results of the diagnostic tumor biopsy and bone marrow biopsy, and results of flow cytometry, cytogenetics, and molecular studies.
OTHER	medical chart review	Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.

Timeline

• Start date: 2013-01-02
• Primary completion: 2022-01-14
• Completion: 2022-01-14
• First posted: 2012-03-30
• Last updated: 2023-03-16
• Results posted: 2023-03-16

Locations

14 sites across 1 country: United States