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

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.

• DNA analysis (Genetic): This sample will be used for germline DNA analysis.
• RNA analysis (Genetic): RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.
• gene expression analysis (Genetic): 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.
• polymorphism analysis (Genetic): 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.
• biologic sample preservation procedure (Other): 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.
• flow cytometry (Other): 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.
• medical chart review (Other): Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.

Primary outcomes

• Collection of Tissue Specimen From Study Participants [Study entry (prior to chemotherapy initiation)]: Summary of the specimens available by study arm

Sex: All, ages: 18 Years to any

DISEASE CHARACTERISTICS:

* Participants must have a diagnosis of a malignancy or clinical findings suggestive of a possible HIV-associated malignancy of one of three types:

  * Diffuse large B-cell lymphoma
  * Non-small cell lung malignancy
* The presence of any of the following conditions will exclude a participant from study enrollment:

  * Absence of sufficient diagnostic tumor-biopsy tissue material to meet the protocol requirements for baseline specimen submission (minimum specimen size of 10 x 10 x 2 mm); repeat tumor biopsy will not be performed solely to meet the protocol specimen-collection requirements
  * Participants whose biopsies, for the purpose of this protocol, show a diagnosis of anal intraepithelial neoplasia or cervical intraepithelial neoplasia
  * Prior treatment for the study malignancy (including neo-adjuvants), since treatment can affect the mutational spectra of tumors
* HIV infection based on serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive western blot, or any other Food and Drug Administration (FDA)-approved (licensed) HIV test; alternatively, this documentation may include a record that another physician has documented that the patient has HIV based on prior ELISA and western blot, or other approved diagnostic tests

PATIENT CHARACTERISTICS:

* Participants must be willing and able to sign an IRB-approved informed consent document

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Participant flow

Outcome results

• Collection of Tissue Specimen From Study Participants (Primary), Count of participants, Participants: HIV-positive Diffuse Large B-cell Lymphoma Cases 85; HIV-positive Lung Cancer Cases 18; HIV Positive Cervical Cancer Cases 2

Adverse events

Time frame: Adverse events data was not collected for this study..

• Study Protocol and Statistical Analysis Plan (PDF, 2020-11-25)
• Informed Consent Form (PDF, 2020-11-18)

• Lee Ratner, MD, PhD, Principal investigator, Washington University Siteman Cancer Center

NIH grants: U01CA121947