Vanderbilt Network Lead Academic Participating Site for the NCTN

PROJECT SUMMARY/ABSTRACT Vanderbilt-Ingram Cancer Center (VICC) is a matrix cancer center within Vanderbilt University Medical Center (VUMC). VICC has been part of the cooperative group system for over 30 years, and a Lead Academic Participating Site (LAPS) since the inception of the National Clinical Trials Network (NCTN). Throughout the years, we have integrated our physicians into leadership roles and our basic science into investigator-initiated trials, as well as enrolled patients onto clinical trials. Additionally, VICC has a long track record of leadership, both scientific and administrative, within the cooperative groups, and mentoring junior faculty in clinical trial development. VICC brings great strengths to the NCTN, including two SPORE grants, an EDRN grant, eight highly funded scientific programs, and an Early Therapeutics Clinical Trial Network (ETCTN) grant. Our Personalized Cancer Medicine Initiative (PCMI) is dedicated to matching the appropriate therapy to the genomic alterations that are driving the growth of cancers, with an active research component investigating mechanisms of resistance to targeted therapies. VICC clinicians and scientists are academic leaders in their respective disciplines and will continue to significantly contribute to the NCTN goals with the objective to improve the outcomes for cancer patients. Kristen Ciombor, MD, serves as Principal Investigator and leads the efforts of the institution to integrate its scientific, academic and patient resources into the NCTN. She has been involved extensively in the cooperative groups/NCTN in conduct of clinical trials, including leadership and receipt of expert mentorship. In recognition of her active engagement and leadership in NCI-funded collaborative clinical trials, she was named a recipient of the 2021 National Cancer Institute Cancer Clinical Investigator Team Leadership Award. Dr. Ciombor will leverage this experience and continue to successfully lead our NCTN program at VICC. To assist Dr. Ciombor with the conduct of this grant, VICC created two advisory boards, Internal Advisory Board (IAB) and NCTN Executive Committee (NEC), whose membership includes a broad representation of medical disciplines and disease interests across VICC and VUMC. The IAB assures the optimal use of the grant, such as budget review, assurance of multidisciplinary involvement, and participation throughout the NCTN. The NEC implements operational functions, such as trial opening, accrual and mentoring. Operationally, the NEC has actively managed NCTN trial opening, accruals and participation across disciplines and groups, including identification of barriers for timely activation of NCTN trials. Both the IAB and NEC work to integrate VICC science into the NCTN. The VICC Clinical Trials Office and its NCTN team ensures that regulatory, biospecimen, radiology and data submissions are timely and highly accurate. This grant details the expert leadership and mentorship that VICC faculty have provided to the NCTN cooperative groups.