Clinical Research Office
The mission of the UF Health Cancer Center Clinical Research Office, or CRO, is to help deliver new and promising cancer treatments that improve the lives of our patients at the UF Health Cancer Center. The CRO provides support to our clinical investigators for the development and implementation of cancer clinical trials — facilitating the conduct of high-quality clinical research while adhering to the highest ethical standards and maintaining compliance with all governing bodies.
About the Clinical Research Office
The CRO is committed to supporting clinical research addressing the complex needs of the catchment area and the patients we serve, with an emphasis on providing access to novel therapies. The office provides comprehensive resources to investigators for the efficient conduct of cancer clinical research with representative inclusion of minorities, women, children and the elderly.
Currently, the clinical research program consists of the CRO and 10 disease- specific working groups (e.g., thoracic, GI, GU, neuro-oncology, hematologic malignancies). It also supports an experimental therapeutics group for early phase clinical trials as well as a Cancer Population Sciences group. These two groups support trials that may be relevant to patients across several different cancer types. Additionally, the CRO provides clinical trial support for institutions that are affiliated with UF Health, the university’s academic health center.
Affiliate Clinical Research Sites Include:
- Broward Health Medical System (Fort Lauderdale, FL)
- North Florida/South Georgia Veterans Health System (Gainesville, FL)
- Orlando Health UF Health Cancer Center (Orlando, FL)
- Tallahassee Memorial Cancer Center (Tallahassee, FL)
- UF Health Proton Therapy Institute (Jacksonville, FL)
- Watson Clinic Cancer & Research Center (Lakeland, FL)
Clinical Research Office Leadership
Thomas George, M.D.
Associate Director, Clinical Research
Alison Ivey, R.N., M.S., O.C.N., CCRP
Administrative Director
Ashley Anderson, M.B.A., ACRP-CP
Assistant Director, Clinical Research Administration and Compliance
Alisha Daniels, M.D., M.H.A., CCRC, ACRP-PM
Assistant Director, Project Management and Regulatory Affairs
Leslie Pettiford, R.N., M.S., O.C.N., CCRC
Assistant Director, Study Coordination and Data Management
Clinical Research Highlights
In 2019, the Clinical Research Office helped the Cancer Center realize various accomplishments in alignment with its mission — to deliver new and promising cancer treatments in order to improve the lives of the patients at the UF Health Cancer Center.
- The CRO supported 5,725 accruals in cancer clinical trials.
- Enrollments to treatment trials climbed from 365 in 2018 to 449 in 2019 — over a 20% increase.
- By the end of 2019, 80% of all eligible CRO staff were research certified through either the Society of Clinical Research Associates or the Association of Clinical Research Professions.
- The CRO initiated Precision Promise, an initiative of the Pancreatic Cancer Action Network and the first large- scale precision medicine trial designed to transform outcomes for patients with pancreatic cancer. UF Health is one of 14 national centers chosen to participate.
Selecting best-suited clinical trials
The UF Health Cancer Center has 12 Disease Site Groups, 10 disease-specific and two disease-agnostic, that consist of both research and clinical leaders. Each Disease Site Group is charged with developing and maintaining a portfolio of trials that brings forward scientific hypotheses developed in the Cancer Center Research Programs and is relevant to the Cancer Center’s catchment area. All newly proposed interventional trials must be endorsed first by the appropriate Disease Site Group. During the first-stage of review, Disease Site Groups emphasize prioritization, catchment area and clinical needs. In 2018, the Disease Site Groups reviewed 228 interventional trials, only 74 of which were endorsed. This demonstrates that the Disease Site Groups are highly selective in bringing only the best-suited clinical trial options forward for their patients.
Clinical Trial Navigator
The UF Health Cancer Center’s Clinical Trial NaviGATOR mobile app gives patients and clinicians the ability to browse cancer clinical trials at the center by disease site and criteria, and to contact the center to make referrals or get additional information. The NaviGATOR is available on the web and is also available as an app for mobile devices.
Selected Clinical Trials
Breast
Phase: III
NCT02927249
Investigator: Karen C. Daily Weinstein, D.O.
Title: A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial
Experimental Therapeutics Group
Phase: II
NCT03207347
Investigator: Thomas J. George, M.D., FACP
Title: Phase II Trial of the PARP1 Inhibitor, Niraparib, in BAP1 and other DNA Damage Response (DDR) Pathway Deficient Neoplasms (UF-STO-ETI-001)
Phase: II
NCT03924557
Investigator: Rhonda Marsha Dehoff, Pharm. D., M.S.
Title: A Randomized Pragmatic Trial of Genotype-Guided Supportive Care in Symptom Treatment of Cancer Patients (UF-ETG-002)
Cancer Population Science
Phase: N/A
NCT03385577
Investigator: Deidre Pereira, Ph.D.
Title: Feasibility, Acceptability, and Efficacy of a Yoga Intervention for Distress in Women with Gynecologic, Gastrointestinal, or Thoracic Cancer
Phase: N/A
NCT03209440
Investigator: Diane J. Wilkie, Ph.D., R.N., FAAN
Title: Palliative Care for Elderly Outpatients
Gastrointestinal
Phase: N/A
Investigator: Steven John Hughes, M.D.
Title: Protein Signatures Improve the Diagnostic Yield of Fine Needle Aspiration (Aim 3)
Phase: II
NCT03483038
Investigator: Thomas J. George, M.D., FACP
Title: A Phase II, Open-label Evaluating the Safety and Activity of naI-IRI in Combination with 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma (UF-STO-PANC-004)
Genitourinary
Phase: III
NCT03091660
Investigator: Paul Luther Crispenm M.D.
Title: A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming With Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-muscle Invasive Bladder Cancer
Phase: II
NCT03658304
Investigator: Paul Luther Crispen, M.D.
Title: A Single Arm Phase II Trial of the Intraoperative Intravesical Instillation of Mitomycin C During Nephroureterectomy for Urothelial Carcinoma of the Upper Urinary Tract
Phase: III
NCT03561220
Investigator: Nancy P. Mendenhall, M.D., FASTRO
Title: A Prospective Comparative Study of Outcomes with Proton and Photon Radiation in Prostate Cancer
Gynecological
Phase: III
NCT03602859
Investigator: Merry J. Markham, M.D., FACP
Title: A Randomized, Double-Blind, Phase 3 Comparison of Platinum-Based Therapy with Tsr-042 and Niraparib versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III Or IV Nonmucinous Epithelial Ovarian Cancer
Head and Neck
Phase: II
NCT03077243
Investigator: Robert J. Amdur, M.D.
Title: LCCC 1612: P53 mutational status and circulating free HPV DNA for the management of HPV-associated Oropharyngeal Squamous Cell Cancers
Malignant Hematology
Phase: III
NCT03016130
Investigator: John R. Wingard, M.D.
Title: A Phase III, Randomized, Clinical Trial Comparing Two Diets in Patients undergoing Hematopoietic Stem Cell Transplant (HSCT) or Remission Induction Chemotherapy for Acute Leukemia and Myelodysplastic Syndrome
Phase: III
NCT02964325
Investigator: Randall A. Brown, M.D.
Title: Clinical Effectiveness of Standard Versus Mirasol-treated Apheresis Platelets in Patients with Hypoproliferative Thrombocytopenia
Neurologic
Phase: II
NCT02465268
Investigator: Maryam Rahman, M.D.
Title: A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells with Tetanus-Diphtheria Toxoid Vaccine in Patients with Newly- Diagnosed Glioblastoma
Pediatrics
Phase: I
NCT03396575
Investigator: Sridharan Gururangan, FRCP
Title: BRAVO: Newly-Diagnosed Brain Stem Gliomas Treated with Adoptive Cellular Therapy During Recovery from Focal Radiotherapy Alone or Focal Radiotherapy and Dose-intensified Temozolomide (Phase I)
Phase: II
NCT03155620
Investigator: William B. Slayton, M.D.
Title: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol
Sarcoma
Phase: II
NCT03628209
Investigator: Joanne P. Lagmay, M.D.
Title: A Phase Ib/II Study to Evaluate the Safety, Feasibility and Efficacy of Nivolumab or Nivolumab in Combination With Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
Thoracic
Phase: II
NCT03624907
Investigator: Anamaria R. Yeung, M.D.
Title: Consecutive Vs. Non-Consecutive Stereotactic Body Radiotherapy For Early Stage Non-Small Cell Lung Cancer