Official Title
Tissue Acquisition for Analysis of Prognostic Factors, Immunology, and Genetic Progression of HIV-1 Associated Malignancies
Brief Title
Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
Protocol ID
NCT01567722
Lead Sponsor
AIDS Malignancy Consortium
Brief 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.
Study Period
-
Enrollment Count
114 participants
Eligibility 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
Filters
Lung Cancer
Lymphoma
TERMINATED
ADULT
OLDER_ADULT