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Bay Pines VA Research Program

Research projects have significantly contributed to advancements in health care for Veterans and all Americans from every walk of life. VA researchers wouldn't be able to make the advancements they do without the volunteers who take part in our clinical studies. Clinical Research is focused on moving ideas along the translational pathway from scientific discovery to clinical application in order to advance the health care of our Veterans.

Bay Pines VA Healthcare System Research Program

Here at the Bay Pines VA Healthcare System (BPVAHCS) we are dedicated to increasing Veterans' access to high-quality clinical trials; increasing the real-world impact of VA research; putting VA data to work for Veterans; actively promoting diversity, equity, and inclusion; and building community through VA research.

The Medical Research Program is directed by the Associate Chief of Staff for Research & Development (ACOS/R) with the support of an Administrative Officer (AO). The ethical and regulatory oversight for all VA-based research studies is provided through the Institutional Review Board (IRB) of Record and the local BPVAHCS Research & Development Committee (RDC). That means that all project aims and objectives, scientific merit, and any recruitment methods and materials provided to prospective subjects are reviewed and approved by those committees before any participants can enroll.

There are more than 29 clinicians at Bay Pines VA conducting clinical research trials and more than 35 approved and active projects that are currently enrolling participants. Research projects cover a broad range of fields and subjects, to include Mental Health, Pain, Oncology, Cardiology, Infectious Disease, Dermatology, Podiatry, Pulmonology, Genetics, Whole Health, Nephrology, COVID-19, and more.

View the chart below for a list of current projects offered at Bay Pines VAHCS. New projects are continuously being approved so check back regularly to see updates.

Interested in Participating in a Clinical Research Trial?

Any Veteran meeting the inclusion and exclusion qualifications for the clinical research project can request to participate. Participation is voluntary and your decision to participate/not participate will have no bearing on the quality of health care you receive. Participants can opt out of a research study at any time.

Certain projects offer monetary compensation for time and travel.

Contact the Bay Pines VA Healthcare System's Clinical Study Coordinators for information on the project you are interested in joining and the commitment required from you. Research staff will assist you through the entire recruitment and study process.

Support Bay Pines VA Research

The Bay Pines Foundation, Inc. is a private nonprofit organization that aims to improve the health and well-being of Veterans by supporting and advancing VA research and education activities, while observing the highest ethical standards.

The foundation depends on the generosity of individuals, corporations, and other organizations to continue its mission. For more information, please email Caitlin.Mahaney@va.gov or call 727-398-6661, ext. 17926

Spotlight Project of the Month: VA Lung Precision Oncology Program (LPOP)

Nearly 8,000 Veterans are diagnosed and treated in VA for lung cancer each year. An estimated 900,000 are at risk for lung cancer due to age, smoking, and environmental exposures during and after military service. Veterans have a higher rate of lung cancer and a lower rate of survival than the general population. BPVAHCS has been selected to participate in the LPOP program and is offering screening, genetic testing, and participation in clinical trials to ensure that Veterans have access to cutting-edge oncology care.

The VA LPOP, a component of the VHA’s Precision Oncology Initiative, aims to give VA clinicians a range of tools to proactively address and treat lung cancer in Veterans. Precision oncology uses patients’ unique genetic profiles from their tumor to tailor individualized treatment and connect them with new therapies through clinical trials. The program goals include:

  • Prioritizing screening to identify early-stage lung cancer in high-risk Veterans
  • Offering genetic testing for Veterans with advanced lung cancer
  • Improving access to precision-oncology clinical trials for Veterans with advanced lung cancer
  • Increasing the number of clinical trials available to provide Veterans with new treatment options for lung cancer
  • Enabling rapid translation of discoveries into clinical care
Study Area Title/BP Study Number Synopsis Study Team Status Back Pain VA CSP #2009 Sequential and Comparative Evaluation of Pain Treatment Effectiveness Response: The SCEPTER Trial Study #1644021 This is a randomized trial of patients with back pain of at least 6 months duration will be randomized to SM, SM-PT or CCAM. Participants will be assessed every three months until 12 months after initiating their final trial therapy. Local PI: Ryan Diana, DC Hayley Maither Hayley.Maither@va.gov 727-398-6661, ext. 10151 Enrolling Bladder Cancer A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) versus CRT Alone in Participants with Muscle-invasive Bladder Cancer (MIBC). Study #1573968 This is a trial for muscle-invasive bladder cancer to compare intact event-free survival in participants from Arm A (pembrolizumab + chemoradiotherapy) and Arm B (placebo + chemoradiotherapy). Local PI: Andrew Leone, MD Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 10791 Closed to enrollment, re-opening at site Bladder Cancer An observational study of efficacy and utility of Cxbladder tests in the identification of low vs high risk patients and the detection of urothelial carcinoma in patients presenting with hematuria. Study #1683093 This is an observational study recruiting patients presenting with blood in the urine, who are undergoing investigation for the presence of Urothelial Carcinoma. This study is designed to compare the Cxbladder tests versus standard of care procedures. Local PI: Andrew Leone, MD Mariah Alexis Mariah.Alexis@va.gov 727-398-6661, ext. 10152 Rachel Sullivan Rachel.sullivan1@va.gov 727-398-6661, ext. 17842 Enrolling Cardiology Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults (PREVENTABLE) Trial Study #1612747 PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study that will evaluate if taking a statin could help older adults live independently for longer by preventing dementia, disability, or heart disease. PREVENTABLE will randomly assign Atorvastatin 40 mg daily or matching placebo once daily to 20,000 community-dwelling adults ≥75 years of age without clinically evident cardiovascular disease, significant disability, or dementia, and follow them for up to 5 years. Clinical Trials: Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults - Full Text View - ClinicalTrials.gov Local PI: Dennis Hall Chayla Lee Chayla.lee@va.gov Ext. 10111 Cortny Withee Cortny.Withee@va.gov 727-398-6661, ext. 15900 Enrolling Cardiology A Multi-Center Study Evaluating Participants who Received CanGaroo® Envelope, TYRX™ Envelope, or No Envelope During CIED Implantation Study #1605396 The purpose of this study is to look at the differences of healing and complications in patients who have had previous heart device procedures done. The study will compare the results of the previous procedure (a type of envelope used or no envelope used). Clinical Trials: Comparison of Participants Who Received a CanGaroo® Envelope, TYRX™ Envelope, or no Envelope During CIED Implantation - Full Text View - ClinicalTrials.gov Local PI: Afolabi Sangosanya, MD Cortny Withee Cortny.Withee@va.gov 727-398-6661, ext. 15900 Chayla Lee Chayla.Lee@va.gov 727-398-6661, ext. 10111 Enrolling Cardiology CSP2002 VA-IMPACT Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes Study # TBD VA Cooperative Studies Program #2002 will determine whether treatment with metformin, compared with placebo, reduces the risk of major adverse cardiovascular events (MACE) in patients with pre-diabetes and established atherosclerotic cardiovascular disease (ASCVD). Local PI: Manjunath Harlapur, MD Stella Inting-Toothman 727-398-6661, ext. 17184 727-776-8687 Stella.inting-toothman@va.gov Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 To be Launched Genetics Million Veteran Program “MVP” Study #1612959 A national research program to learn how genes, lifestyle, and military exposures affect health and illness. All Veterans can participate in this one-time only blood collection project. MVP Online Fact Sheet Local PI: Daniel Hogan MD Gary Smith gary.smith@va.gov 727-398-6661, ext. 17284 or ext. 15148 Enrolling GI FORTE (Five- or Ten-Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps) Study #1746496 This study is to determine the benefit and yield of surveillance colonoscopy in patients with non-advanced adenomas is a high priority because of the high prevalence of adenomas. Veterans are randomized to either receive a colonoscopy 5-year post identification or 10 years post identification of adenomas. Local PI: Ryan Burri, MD Rachel Sullivan Rachel.sullivan@va.gov 727-398-6661, ext. 17842 Pending IRB approval Head and Neck Cancer Randomized Phase II/III Trial of Radiation with High-Dose Cisplatin (100 mg/m2) Every Three Weeks versus Radiation with Low-Dose Weekly Cisplatin (40 mg/m2) for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) (NCT05050162) Study #1682403 This study for patients with locoregionally advanced squamous cell carcinoma of the head and neck is to determine whether radiation with low-dose cisplatin weekly is superior in terms of acute toxicity to radiation with high-dose cisplatin every 3 weeks. Local PI: Ryan Burri, MD Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 17842 Mariah Alexis Mariah.Alexis@va.gov 727-398-6661, ext. 10152 Enrolling Infectious Disease Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V Study #1624732 Phase III clinical trial to evaluate the safety and efficacy of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia coli Disease in Adults Aged 60 Years And Older with a History of Urinary Tract Infection in the Past 2 Years Clinical Trials: https://clinicaltrials.gov/study/NCT04899336 Local PI: Kaley Tash, MD Anna Rosenblatt Anna.Rosenblatt2@va.gov 727-398-6661, ext. 17051 or 727-317-7361 Cortny Withee Cortny.Withee@va.gov 727-398-6661, ext. 15900 Enrolling Infectious Disease CSP #2001 Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA INTREPID) Study #1613455 VA Cooperative Study #2001 is a prospective, randomized, double-blind investigation of the addition of 6 weeks of rifampin, 600 mg daily, vs. matched placebo (riboflavin) to standard-of-care, backbone antimicrobial therapy for Diabetic Foot Osteomyelitis. The primary endpoint is amputation-free survival. Clinical Trials: Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics - Full Text View - ClinicalTrials.gov Local PI: Melissa Abercrombie, MD Cortny Withee Cortny.Withee@va.gov 727-398-6661, ext. 15900 Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Enrolling Infectious Disease CSP #596 Optimal Treatment for Recurrent Clostridium difficile Infection (OpTION) Study #1613094 The primary objective of this study is to determine whether 1) standard fidaxomicin treatment and 2) standard vancomycin treatment followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment alone for sustained clinical response at day 59 for all treatments, for participants with either their first or second recurrence of C. difficile infection. Clinical Trials: Optimal Treatment for Recurrent Clostridium Difficile - Full Text View - ClinicalTrials.gov Local PI: Kaley Tash, MD Cortny Withee Cortny.Withee@va.gov 727-398-6661, ext. 15900 Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Enrolling Lung Cancer Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial “VALOR” CSP 2005 Study #1573963 Veterans diagnosed with stage I non-small cell lung cancer who are healthy enough to have surgery, agree to be randomized to either surgery (standard of care treatment) or an alternative non-surgical treatment - Stereotactic Radiotherapy (SBRT). Clinical Trials: NCT02984761 Local PIs: Edward Hong, MD Ryan Burri, MD Marlena Kern, RN marlene.kern@va.gov (VA cell) 727-219-7174 Enrolling Lung Cancer LungLife AI Inc. Study #1651410 The objective of this study is to use blood draws to validate a device developed by LungLife AI Inc in detecting circulating tumor cells for patients presenting with pulmonary nodules. The test aims to aid in the detection of early-stage lung cancer. Clinical Trials: NCT05171491 Local PI: Stephen Clum, MD Mariah Alexis Mariah.alexis@va.gov 727-398-6661, ext. 10152 Kameron Wheelock Kameron.wheelock@va.gov 727-398-6661, ext. 17842 Closed Lung Cancer REFLECTION: Real World Evidence for Learnings in Early Cancer Detection, a Clinical Practice Learning Program for Galleri The study will help collect generalizable knowledge to further evaluate the feasibility, acceptability, and use of an multi-cancer early detection (MCED) test in clinical settings. An MCED test can provide a clinically important complement to current standard-of-care (SOC) population-based screening tests and address unmet medical needs for cancers without current screening modalities. Local PI: Stephen Clum, MD Ronald Eland Ronald.eland@va.gov 727-398-6661, ext. 10791 Pending R&D and IRB approval Lung Cancer NIGHTINGALE: CliNIcal Utility of ManaGement of Patients witH CT and LDCT Identified Pulmonary Nodules UsinG the Percepta NasAL Swab ClassifiEr – with Familiarization Study #1725444 The purpose of this research is to evaluate the usefulness of a genomic test (of your genes), the Percepta Nasal Swab, in determining the risk of lung cancer - when a lung nodule is detected by imaging performed as part of lung cancer screening or incidentally during a medical workup. The genomic test will utilize a nasal brush. This research includes genome sequencing of RNA, which is a copy of DNA or the building blocks (nucleotides) in your genetic code. You qualify for the study because you have a lung nodule. Local PI: Stephen Clum, MD Mariah Alexis Mariah.alexis@va.gov 727-398-6661, ext. 10152 Kameron Wheelock Kameron.wheelock@va.gov 727-398-6661, ext. 17842 Enrolling Lung Cancer A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Study #1600510 This is a study assessing the efficacy and safety of durvalumab versus placebo with standard of care Stereotactic Body Radiation Therapy (SBRT) in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) Non-Small Cell Lung Cancer. Local PI: Ryan Burri, MD Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 10791 Ronald Eland Ronald.eland@va.gov 727-398-6661, ext. 10791 Enrolling Lung Cancer A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation Study #1679339 This is a study assessing the efficacy and safety of Adagrasib alone and in combination with Pembrolizumab as a first-line treatment in patients with Advanced Non-Small Cell Lung Cancer with a KRAS G12C mutation. Patients will be randomized to different arms depending on their Tumor Progression Score (TPS) Local PI: Ryan Burri, MD Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 10791 Mariah Alexis Mariah.Alexis@va.gov 727-398-6661, ext. 10152 Enrollment Hold Nephrology Pentoxifylline in Diabetic Kidney Disease (VA PTXRx) Study #CSP 2008 Compare the time until End Stage Renal Disease or death between participants randomized to Pentoxifylline (PTX) or placebo. Local PI: Hemalatha Gutta, MD Lori Sisler Lorine.sisler@va.gov 727-398-6661, ext. 17596 Enrolling Opioid Abuse Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans “VA BRAVE” CSP 2014 Study #1573941-4 Treat veterans with Opioid Use Disorder (OUD) to understand whether Buprenorphine a medication to treat OUD, given in a monthly injection form works similarly to or better than buprenorphine oral form. Participation in the study will last 1 year. Clinical Trials: NCT04375033 Local PI: Maha Lahoud-Bladykas, MD Chris Vallanat christopher.vallanat@va.gov 727-398-6661, ext. 15992 Mariah Alexis mariah.alexis@va.gov 727-398-6661, ext. 10152 Enrolling Opioid Abuse “INDIVIOR”: A Randomized, Double-Blind Study Comparing 2 Maintenance Dosing Regimens of Buprenorphine Extended-Release Subcutaneous Injection (RBP-6000) in Treatment-Seeking Adult Participants with Opioid Use Disorder and High-risk Opioid Use Study #1651131 The primary objective of the maintenance phase is to compare the efficacy of 100 mg and 300 mg maintenance doses of extended-release buprenorphine administered every 4 weeks. Clinical Trials: NCT04995029 Local PI: Maha Lahoud-Bladykas, MD Mariah Alexis mariah.alexis@va.gov 727-398-6661, ext. 10152 Chayla Lee Chayla.lee@va.gov 727-398-6661, ext. 10111 Closed to Enrollment Prostate Cancer COBRA: An open-label, multicenter phase II study to compare the efficacy of carboplatin as first-line followed by second-line olaparib versus olaparib as first-line followed by second-line carboplatin in the treatment of patients with castration resistant prostate cancer containing homologous recombination deficiency Study #1612483 To determine progression free survival (PFS) to initial therapy (PFS-1L) with carboplatin vs. olaparib in the treatment of patients with metastatic castration resistant prostate cancer (mCRPC) containing inactivation of the homologous DNA repair pathway, including BRCA1, BRCA2, PALB2, BARD1, BRIP1, CHEK1, FANCL, RAD51B, RAD51C, and RAD54L. Local PI: Ryan Burri, MD Laurie Emmert Laurie.emmert@va.gov 727-398-6661, ext. 10152 Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 10791 Enrolling Prostate Cancer VA STARPORT: Veterans Affairs Seamless Phase II/III Randomized Trial of Standard Systemic Therapy with or without PET-directed Local Therapy for Oligorecurrent Prostate Cancer Study #1616760 This is an interventional study for patients with oligorecurrent prostate cancer to determine whether adding metastasis-directed therapy to standard systemic therapy improves disease outcomes further. This study also determines if certain mutations present in tumor DNA can predict if Veterans will benefit from PET-directed local therapy. Local PI: Ryan Burri, MD Laurie Emmert Laurie.emmert@va.gov 727-398-6661, ext. 10152 Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 10791 Enrolling Prostate Cancer VA Multi-Omics Analysis Platform for Prostate Cancer and Sequencing (VA MAPP-SEQ) Biorepository Study #1713735 Biorepository for men with the potential to be diagnosed with prostate cancer or having a diagnosis of prostate cancer scheduled to undergo surgical/non-surgical procedure on the prostate gland or metastatic tissue. The purpose of this study is to create a centralized biorepository for future research for Veterans with prostate cancer. Local PI: Andrew Leone, MD Laurie Emmert Laurie.emmert@va.gov 727-398-6661, ext. 10152 Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 10791 Enrolling Prostate Cancer A Single-arm, Open-label, Phase II Study of Checkpoint Inhibitors in Men with Progressive Metastatic Castrate Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation (CHOMP) Study #1612473 The primary objective of this study is to assess the activity of the checkpoint inhibitor, pembrolizumab) in Veterans with mCRPC with either dMMR or CDK12- /- that has progressed on at least one prior therapy inclusive of either enzalutamide and/or abiraterone acetate. Local PI: Ryan Burri, MD Laurie Emmert Laurie.emmert@va.gov 727-398-6661, ext. 10152 Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 10791 Enrolling Prostate Cancer Identification of Targetable Prostate Cancer Alterations Through Tumor DNA Screening Study #1573965 This is an observational, non-interventional study of screening veterans receiving care within Bay Pines VA Healthcare System who carry the diagnosis of advanced prostate cancer, metastatic or recurrent, for the presence of DNA mutations in tumor or germline DNA which could provide access to therapies with potential to significantly prolong survival. Local PI: Ryan Burri, MD Kameron Wheelock Kameron.Wheelock@va.gov 727-398-6661, ext. 17842 Mariah Alexis Mariah.Alexis@va.gov 727-398-6661, ext. 10152 Enrolling Psoriasis A Multicenter, Open Registry of Patients with Psoriasis who are Candidates for Systemic Therapy Including Biologics "PSOLAR" Study #1573980 Observational Study collecting information related to the treatment of psoriasis and evaluates patient and disease characteristics, patient-reported assessments and clinical and quality of life outcomes. Clinical Trials: NCT00508547 Local PI: Daniel Hogan, MD Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Closed to Enrollment Psoriatic Arthritis Solstice- Guselkumab therapy in patients with active Psoraitic Arthritis (PsA) Study #1634796 For Veterans with active psoriatic arthritis who have failed a prior anti-TNF (Humira, Enbrel, etc.) The primary objective is to evaluate the efficacy of guselkumab. Clinical Trials: NCT04936308 Local PI: Priyanka Murali, MD Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Enrolling Psoriatic Arthritis Star- Guselkumab therapy in patients with Psoraitic Arthritis (PsA) who have never been treated with a biologic before Study # 1634798 For Veterans who have never been treated with a biologic with MRI confirmed axial disease. The goal is to evaluate the efficacy of guselkumab by assessing reduction in axial symptoms. Clinical Trials: NCT04929210 Local PI: Priyanka Murali, MD Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Enrolling Psoriatic Arthritis Affinity- Combination therapy with guselkumab and golimumab in patients with Psoriatic Arthritis (PsA) Study # 1634801 For Veterans with active psoriatic arthritis, who have failed prior treatment of anti-TNF (Humira, Enbrel, etc.) and are interested in a dual therapy of guselkumab AND golimumab. Clinical Trials: NCT05071664 Local PI: Priyanka Murali, MD Sarah Crim sarah.crim@va.gov 727-398-6661, ext. 17975 Closed to Enrollment PTSD/ Insomnia CSP #2016 National Adaptive Trial for PTSD related Insomnia (NAP) Study #1612520 A clinical trial to compare the efficacy of trazodone hydrochloride, eszopiclone, and gabapentin to placebo, as adjunctive therapies in the treatment of insomnia symptoms among veterans with military related PTSD. Local PI: Ateiat Philips, MD Stella Inting-Toothman 727-398-6661, ext. 17184 727-776-8687 Stella.inting-toothman@va.gov Enrolling Pulmonary/ COPD A Phase III, Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety to Two Dose Regimens of Tozorakimab in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (TITANIA). Study #1672631 For Veterans 40 years and older with a diagnosis of COPD who have a history of exacerbations within the past year. The goal is to evaluate the efficacy and safety of Tozorakimab 300mg vs placebo every 4 weeks dose regimens. Local PI: Ravi Patel, MD Sarah Crim Sarah.Crim@va.gov 727-398-6661, ext. 17975 Chayla Lee Chayla.Lee@va.gov 727-398-6661, ext. 10111 Enrolling

Research & Development Service Administrative Office Contact Information

Email: vhabayresearch@va.gov