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Principal Investigator: Lisa M Barroilhet
Organization: UNIVERSITY OF WISCONSIN-MADISON
Fiscal Year: 2024
Award: $1,552,933
Funding agency: National Cancer Institute
ABSTRACT
The need to provide safe and cost-effective measures to prevent Cancer is self-explanatory. The University of
Wisconsin (UWISC) as the Lead Academic Organization (LAO) together with our collaborating institutions
(Affiliated Organizations/AOs) propose to continue performing early phase cancer prevention trials, for the
National Cancer Institute (NCI), Division of Cancer Prevention (DCP), as a Cancer Prevention Clinical Trials
Network (CP-CTNET) site funded as a UG1 Consortium as described in RFA-CA-18-031. Our overarching goal
is to evaluate the effects of novel preventive agents/interventions on pertinent biological endpoints in order to
efficiently determine their appropriateness for further testing and potential viability toward becoming
recommended societal interventions to lessen the burden of cancer. We will pursue this overarching goal via
the following specific aims: (1) Efficiently design, conduct and perform Phase 0, 1, 2 Chemoprevention Clinical
Trials of novel and/or re-purposed immunologic-based or molecular targeted agents, assessing their effects upon
relevant biological (biomarkers/clinical effects) endpoints. (2) Build upon existing consortium infrastructure to
complete Aim 1 via intra- or inter-consortium (CP-CTNET) multi-institutional collaborations in concert with
NCI/DCP contributing three to four new Phase 0, 1 or 2 clinical trials and accrual of ≥ 40-50 subjects per year.
We are well positioned to successfully achieve the above aims due to our combined experience with prevention
agent development (consortium members currently hold >90 DCP sponsored R, U or PREVENT awards) and
our consortium's staffing, organization, and management which results in the timely development, performance
and completion of impactful, multi-institutional early phase cancer prevention trials. Our enhanced consortium
consists of >10 NCI-designated Cancer Centers, institutions providing access to robust numbers of at-risk
patients (e.g. Mayo Clinics, Seattle Cancer Care Alliance) and expanded access to at-risk under-represented
minorities and special populations (e.g. University of Puerto Rico, Alaska Native Medical Center). Supported by
the Carbone Cancer Center, the University of Wisconsin CP-CTNet site is determined to contribute to advancing
the field of Cancer prevention through performance of early phase prevention trials.
Terms: <Acceleration><Advanced Cancer><Advanced Malignant Neoplasm><Alaska Indian><Alaska Native><Alaskan American><Alaskan Indian><Alaskan Native><Alaskan Native American><Award><Biological><Biological Markers><Body Tissues><Cancer Burden><Cancer Center><Cancer Patient><Cancer Prevention Trial><Cancer Treatment><Cancers><Chemoprevention><Chemopreventive><Chemopreventive Agent><Clinic><Clinical><Clinical Chemoprevention><Clinical Evaluation><Clinical Testing><Clinical Trials><Clinical Trials Network><Collaborations><Development><Division of Cancer Prevention><Dose><Dysplasia><Epidemiological data><Epidemiology data><Formulation><Funding><Genetic Predisposition><Genetic Predisposition to Disease><Genetic Susceptibility><Genetic propensity><Goals><Groups at risk><Histologic><Histologically><History><Immunochemical Immunologic><Immunologic><Immunological><Immunologically><Immunologics><Immunoprevention><Individual><Individuals from minority><Individuals of minority><Infrastructure><Inherited Predisposition><Inherited Susceptibility><Institution><Intervention><Intervention Strategies><Investigators><Investments><Lead><Malignant Neoplasm Therapy><Malignant Neoplasm Treatment><Malignant Neoplasms><Malignant Tumor><Medical center><Minority Groups><Minority People><Minority Population><Minority individual><Molecular Target><NCI Organization><National Cancer Burden><National Cancer Institute><Neoplasms><Organ><Organizational Affiliation><Participant><Patients><Pb element><People at risk><Performance><Persons at risk><Pharmacodynamics><Phase><Population><Populations at Risk><Position><Positioning Attribute><Preventative measure><Prevention><Prevention program><Prevention trial><Preventive><Preventive measure><Principal Investigator><Process><Productivity><Puerto Rico><Recommendation><Recording of previous events><Reproducibility><Research><Research Personnel><Researchers><Risk><Science><Screening procedure><Site><Special Population><Specialty><Testing><Time><Tissues><Underrepresented Ethnic Minority><Underrepresented Minority><Universities><Vaccines><Wisconsin><anti-cancer therapy><anti-carcinogenic><anticarcinogenic><bio-markers><biologic><biologic marker><biomarker><cancer care><cancer chemoprevention><cancer clinical trial><cancer prevention><cancer progression><cancer therapy><cancer-directed therapy><chemoprevention agent><clinical effect><clinical relevance><clinical significance><clinical test><clinically relevant><clinically significant><cost effective measures><design><designing><developmental><drug repositioning><drug repurposing><dyscrasia><epidemiologic data><experience><first in man><first-in-human><genetic etiology><genetic mechanism of disease><genetic vulnerability><genetically predisposed><healthy volunteer><heavy metal Pb><heavy metal lead><high risk><high risk group><high risk individual><high risk people><high risk population><histories><improved><innovate><innovation><innovative><interventional strategy><malignancy><medical specialties><member><multidisciplinary><neoplasia><neoplasm progression><neoplasm/cancer><neoplastic growth><neoplastic progression><novel><oncology clinical trial><phase 1 trial><phase I trial><pilot trial><prevent><preventing><prevention clinical trial><repurposing agent><repurposing medication><research clinical testing><screening tools><targeted agent><tumor progression><under-representation of minorities><under-represented minority><underrepresentation of minorities><vaccination study><vaccination trial><vaccine study><vaccine trial>