The University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute (UT MDAH), an NCI-designated Comprehensive Center, proposes to become a Research Base in the Community Clinical Oncology Program (CCOP). This proposal will encompass both clinical treatment trials and cancer control research. UT MDAH has affiliated with 28 CCOP applicants, and offered 33 treatment protocols and 8 cancer control studies for CCOP participation. The CCOPs have projected an accrual of 979 patients (735.7 credits) to treatment protocols and 1880 subjects (889.4 credits) to cancer control. UT MDAH will accrue 510 subjects (226 credits) to these cancer control studies. A CCOP Central Office with two Data Management Units for clinical trials and cancer control will integrate the data of the CCOPs into the well-established data management systems of the Center. Procedures for patient registration, data collection (including CCOP data forms), data editing for quality control, toxicity surveillance, and pathology review have been developed. CCOP research nurses will serve as a bridge between community CCOP personnel and UT MDAH protocol research nurses. An annual onsite audit by a team that will include a community CCOP member will provide quality assurance, allow consistent evaluation of proficiency status, and strengthen the network. UT MDAH will utilize the full scientific, epidemiologic and statistical resources of its Department of Cancer Prevention and Control to develop a complete cancer control research program. Procedures for protocol identification, and collaboration with basic and clinical scientists both within and outside the Center are well- defined. A cancer control accrual credit system has been implemented. In a pilot project that implemented the CCOP procedures, 31 patients from seven CCOP applicants were placed on UT MDAH treatment and cancer control protocols through the CCOP office. This demonstration of the capacity to easily incorporate CCOP data into existing systems, establishes UT MDAH's ability to serve as a CCOP Research Base.
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