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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 Bladder Cancer KEYNOTE-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). Clinical Trial- NCT04241185 Local PI: Andrew Leone, MD Ronald Eland ronald.eland@va.gov (727) 398-6661 Ext. 15925 Chayla Lee chayla.lee@va.gov (727) 398-6661 Ext. 15900 Enrolling Cardiology 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: NCT04262206 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: Dennis Hall Chayla Lee chayla.lee@va.gov (727) 398-6661 Ext. 15900 Enrolling Cardiology VA-IMPACT- Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes. VA CSP #2002 Study #1612520 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). Clinical Trial: NCT02915198 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 Enrolling Diabetes VA INTREPID- Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics VA CSP #2001 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: NCT03012529 Local PI: Melissa Abercrombie, MD Sarah Crim sarah.crim@va.gov (727) 398-6661 Ext. 17975 Enrolling Diabetes VA PTXRx- Pentoxifylline in Diabetic Kidney Disease VA CSP# 2008 Study # 1707595 Compare the time until End Stage Renal Disease or death between participants randomized to Pentoxifylline (PTX) or placebo. Clinical Trial- NCT03625648 Local PI: Hemalatha Gutta, MD Lori Sisler lorine.sisler@va.gov (727) 398-6661 Ext. 17596 Chayla Lee Chayla.lee@va.gov (727) 398-6661 Ext. 15900 Enrolling Diabetes MAVERICKS- Concurrent optical and magnetic stimulation (COMS) for treatment of refractory diabetic foot ulcer; a prospective randomized, sham-controlled, double-blinded, pivotal clinical trial Study # 1752655 The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). Clinical Trials: NCT05758545 Local PI: Melissa Abercrombie, MD Sarah Crim sarah.crim@va.gov (727) 398-6661 x 17975 Enrolling Genetics MVP- Million Veteran Program 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. Clinical Trial: NCT04178122 Local PI: Daniel Hogan MD Gary Smith gary.smith@va.gov (727) 398-6661 Ext.17284; 15148 Enrolling GI NRG-CC005-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. Clinical Trial: NCT05080673 Local PI: Ryan Burri, MD Rachel Sullivan rachel.sullivan@va.gov (727) 398-6661 Ext. 10111 Ronald Eland ronald.eland@va.gov (727) 398-6661 Ext. 15925 Enrolling Head and Neck Cancer NRG-HN009- 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) 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. Clinical trials: NCT05050162 Local PI: Ryan Burri, MD Ronald Eland ronald.eland@va.gov (727) 398-6661 Ext. 15925 Chayla Lee chayla.lee@va.gov (727) 398-6661 Ext. 15900 Enrolling Infectious Disease EmBRACE- 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 vdaccination 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: NCT04899336 Local PI: Kaley Tash, MD Anna Rosenblatt anna.Rosenblatt2@va.gov (727) 398-6661 Ext.17051 or (727) 317-7361 Sarah Crim sarah.crim@va.gov (727) 398-6661 Ext. 17975 Enrolling Lung Cancer VALOR-Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial. VA 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 PI: Edward Hong, MD Marlena Kern, RN marlene.kern@va.gov (VA cell) (727) 219-7174 Enrolling 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 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. Clinical Trials: NCT06426628 Local PI: Stephen Clum, MD Ronald Eland ronald.eland@va.gov (727) 398-6661 Ext. 15925 Elizabeth Lockaby elizabeth.lockaby@va.gov (727) 398-6661 Ext 14392 Enrolling Lung Cancer KRYSTAL-7- 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) Clinical Trial- NCT04613596 Local PI: Ryan Burri, MD Ronald Eland ronald.eland@va.gov (727) 398-6661 Ext. 15925 Elizabeth Lockaby elizabeth.lockaby@va.gov (727) 398-6661 Ext 14392 Enrolling Nephrology AMPLITUDE- A phase II/III Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease Study # 1712458 Phase II/III Trial Investigating use of VX-147 in Adults with APOL-1 Mediated Chronic Kidney Disease to evaluate the efficacy of VX-147 to reduce proteinuria and improve renal function Clinical Trials: NCT05312879 Local PI: Chandana Reddy, MD Chayla Lee chayla.lee@va.gov (727) 398-6661 Ext. 15900 Anna Rosenblatt anna.Rosenblatt2@va.gov (727) 398-6661 Ext.17051 or (727) 317-7361 Enrolling Nephrology I CAN- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN) Study# 1799500 The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression. Clinical Trials: NCT06291376 Local PI: Ashwinikumar Patil, MD Chayla Lee chayla.lee@va.gov (727) 398-6661 Ext. 15900 Anna Rosenblatt anna.Rosenblatt2@va.gov (727) 398-6661 Ext.17051 or (727) 317-7361 Study to open soon Opioid Abuse VA BRAVE- Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans VA CSP 2014 Study # 1573941 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 Enrolling Prostate Cancer NRG-GU009- PREDICT-RT*-Parallel Phase III Randomized trials for High-Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation *Prostate RNA Expression/Decipher to Individualize Concurrent Therapy with Radiation Study # 1694062 This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Clinical Trials: NCT04513717. Chayla Lee chayla.lee@va.gov (727) 398-6661 Ext. 15900 Ronald Eland ronald.eland@va.gov (727) 398-6661 Ext. 15925 Study to open soon Prostate Cancer NRG-GU010- GUIDANCE-Parallel Phase III Randomized Trials of Genomic-Risk Stratification Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation Study # 1694082 The Guidance trial emphasizes personalized care by matching treatment intensity to the individual's cancer aggressiveness, leading to more targeted and effective therapies for prostate cancer patients. This is a clinical trial for men with unfavorable intermediate risk prostate cancer. This trial is checking whether doctors can safely customize treatment based on low or high gene scores. This would potentially reduce unnecessary toxicity from overtreatment and improve outcomes in those with higher need. Clinical Trials: NCT05050084 Local PI: Ryan Burri, MD Chayla Lee chayla.lee@va.gov (727) 398-6661 Ext. 15900 Ronald Eland ronald.eland@va.gov (727) 398-6661 Ext. 15925 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. Clinical Trials: NCT04787744 Local PI: Ryan Burri, MD Ronald Eland ronald.eland@va.gov (727) 398-6661 Ext. 15925 Enrolling Prostate Cancer VA MAPP- VA Multi-Omics Analysis Platform for Prostate Cancer and Sequencing 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 Ronald Eland ronald.eland@va.gov (727) 398-6661 Ext. 15925 Enrolling Prostate Cancer CHOMP- 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 Bi-allelic CDK12 Inactivation 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. Clinical Trials: NCT04104893 Local PI: Ryan Burri, MD Ronald Eland ronald.eland@va.gov (727) 398-6661 Ext. 15925 Enrolling Prostate Cancer ONCOMINE- 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 Ronald Eland ronald.eland@va.gov (727) 398-6661 Ext. 15925 Enrolling 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 Chayla Lee chayla.lee@va.gov (727) 398-6661 Ext. 15900 Enrolling Psoriatic Arthritis STAR- A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Bio-naive Participants with Active Psoriatic Arthritis Axial Disease. 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 Chayla Lee chayla.lee@va.gov (727) 398-6661 Ext. 15900 Enrolling PTSD/ Insomnia NAP- National Adaptive Trial for PTSD related Insomnia CSP #2016 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. Clinical Trials: NCT03668041 Local PI: Ateiat Philips, MD Stella Inting-Toothman (727) 398-6661 Ext. 17184 (727) 776-8687 stella.inting-toothman@va.gov Rachel Sullivan rachel.sullivan@va.gov (727) 398-6661 Ext. 10111 Enrolling Pulmonary/ COPD TITANIA- 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. 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. Clinical Trials: NCT05158387 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. 15900 Enrolling

Research & Development Service Administrative Office Contact Information

Email: vhabayresearch@va.gov

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