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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
HIV-positive diffuse large B-cell lymphoma cases Tissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma.
  • 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.
HIV-positive lung cancer cases Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer.
  • 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.
HIV-positive cervical cancer cases Tissue specimen collection from HIV positive patients with a diagnosis of cervical cancer

More Details

Status
Terminated
Sponsor
AIDS Malignancy Consortium

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.