This proposal extends from our experience as a founding member and major contributor to NCI's Cooperative Human Tissue Network (CHTN) to include HIV infected malignant tissues and biological fluid in our tissue bank (TB). In consortium with the University of Texas Southwestern Medical Center (UTSW) in Dallas, Texas, we combine tissue banking experience and an accessible patient population. The Ohio State University AIDS group (OSU) is funded as an AIDS Clinical Trial Group (ACTG) with 12 open or recently closed protocols and by other sources for 9 current protocols. Approximately 1338 patients have been enrolled in protocols from the beginning of funding. UTSW is funded as a Division of AIDS Treatment Research Initiative (DATRI) with 3 open protocols and by 10 open protocols from non-federal sources. Currently, 357 patients are enrolled in therapy protocols. Ohio is 13th and Texas 4th in number of AIDS cases. Our midwest and southwest locations are strategic for recruitment of low incident malignancies from other federally funded AIDS treatment programs. HIV infected patients, particularly those with low CD4 counts receiving antiviral therapies, will be identified in the clinical setting when suspicious for malignancy. HIV infected malignancies, non-infected control malignancies, peripheral blood mononuclear cells or other tumor cell suspensions including derived tissue culture cell lines from Kaposi's sarcoma, histologic (H&E) stained slides, and paraffin embedded tissue blocks will be procured through Departments of Pathology. Specimens will be collected from remnant surgical, clinical and autopsy tissues or cells not needed for test processing or pathological diagnosis. Cutaneous lesions can be collected, if appropriate, from patient volunteers following consent. Types of malignancies collected and method of storage will be based on research investigator requirements approved by the REDP Collections will be coded and have a pedigree of patient demographics, ongoing clinical protocol evaluations, and clinical outcomes taken from extensive clinical data bases maintained by both-OSU and UTSW AIDS groups. Data will be secured in a dedicated database system customized for tissue banking with prioritized dispersement to researchers (CHTN). The data base can be expanded to include required clinical data. Patient consent and confidentially will be govern by the IRB. Collections will be reviewed by a pathologist for quality verification. Banking activities will be governed by institutional and Steering Committee policy and Federal regulations for prevention of transmission of infection in the workplace. Infection control education, guidelines and notification will extend to investigators receiving infected tissues. Two proposed pilot studies are included.
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