Lung Cancer Clinical Trial
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.
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.
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
Participants must be willing and able to sign an IRB-approved informed consent document
PRIOR CONCURRENT THERAPY:
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There are 14 Locations for this study
La Jolla California, 92093, United States
Los Angeles California, 90095, United States
Washington District of Columbia, 20052, United States
Miami Florida, 33136, United States
Chicago Illinois, 60612, United States
New Orleans Louisiana, 70112, United States
Saint Louis Missouri, 63110, United States
Bronx New York, 10461, United States
New York New York, 10021, United States
Chapel Hill North Carolina, 27599, United States
Philadelphia Pennsylvania, 19106, United States
Philadelphia Pennsylvania, 19111, United States
Seattle Washington, 98104, United States
Seattle Washington, 98111, United States
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