Bay Pines VA Research Program | VA Bay Pines Health Care

Study Area Psoriasis Title/BP Study Number A Multicenter, Open Registry of Patients with Psoriasis who are Candidates for Systemic Therapy Including Biologics “PSOLAR” Study #1573980 Synopsis 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 Study Team Local PI: Daniel Hogan, MD Lori Sisler [email protected] 727-385-0223 Sarah Crim [email protected] 727-398-6661, ext. 17975 Status Enrolling Study Area Genetics Title/BP Study Number Million Veteran Program “MVP” Study #1612959 Synopsis A national research program to learn how genes, lifestyle, and military exposures affect health and illness. All Veterans can participate in this one-time blood collection project. Study Team Local PI: Allison Williams, RN, Ph.D., ND Gary Smith [email protected] 727-398-6661, ext.17284 Lori Sisler [email protected] 727-385-0223 Status Enrolling Study Area Opioid Abuse Title/BP Study Number Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans “VA BRAVE” CSP 2014 Study #1612560 Synopsis 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 Study Team Local PI: Maha Lahoud-Bladykas, MD Chris Vallanat [email protected] 727-398-6661, ext. 15992 Mariah Alexis [email protected] 727-398-6661, ext. 10152 Status Enrolling Study Area Opioid Abuse Title/BP Study Number 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 ”INDIVIOR” Study #1651131 Synopsis 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 Study Team Local PI: Maha Lahoud-Bladykas, MD Mariah Alexis [email protected] 727-398-6661, ext. 10152 Chayla Lee [email protected] 727-398-6661, ext. 10111 Status To be launched Study Area Lung Cancer Title/BP Study Number Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial “VALOR” CSP 2005 Study #1573963 Synopsis 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 Study Team Local PIs: Edward Hong, MD Ryan Burri, MD Marlena Kern, RN [email protected] (VA cell) 727-219-7174 Status Enrolling Study Area PTSD/Mental Health Title/BP Study Number Veteran Health Behavior Study (Wave 2) Study #1573969 Synopsis Observational trial recruiting Veterans who were deployed to Iraq or Afghanistan to learn more about the bidirectional relationships between sleep quality, PTSD symptoms and Alcohol Use Disorder symptoms. Clinical Trials: NCT04552782 Study Team Local PI: Jessica Keith, PhD Anna Rosenblatt [email protected] 727-398-6661, ext.14728 or 727-317-7361 Camille Compton [email protected] 727-398-6661, ext. 14728 or 10151 Status Enrolling Study Area Infectious Disease Title/BP Study Number Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V Study #1624732 Synopsis 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: NCT04899336 Study Team Local PI: Kaley Tash, MD Anna Rosenblatt [email protected] 727-398-6661, ext.17051 or 727-317-7361 Cortny Withee [email protected] 727-398-6661, ext.15900 Status Enrolling Study Area PTSD/Insomnia Title/BP Study Number CSP #2016 National Adaptive Trial for PTSD related Insomnia (NAP) Study #1612520 Synopsis 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. Study Team Local PI: Ateiat Philips, MD Stella Inting-Toothman 727-398-6661, ext. 17184 727-776-8687 [email protected] Status Enrolling Study Area Psoriatic Arthritis Title/BP Study Number Solstice- Guselkumab therapy in patients with active Psoraitic Arthritis (PsA) Study #1634796 Synopsis 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. Study Team Local PI: Priyanka Murali, MD Sarah Crim [email protected] 727-398-6661, ext. 17975 Camille Compton [email protected] 727-398-6661, ext. 14728 or 10151 Status Enrolling Study Area Psoriatic Arthritis Title/BP Study Number Star- Guselkumab therapy in patients with Psoraitic Arthritis (PsA) who have never been treated with a biologic before Study #1634798 Synopsis For bionaive Veterans who have never been treated with a biologic participants with psoriatic arthritis axial disease. The goal is to evaluate the efficacy of guselkumab by assessing reduction in axial symptoms. Study Team Local PI: Priyanka Murali, MD Sarah Crim [email protected] 727-398-6661, ext. 17975 Camille Compton [email protected] 727-398-6661, ext. 14728 or 10151 Status Enrolling Study Area Psoriatic Arthritis Title/BP Study Number Affinity- Combination therapy with guselkumab and golimumab in patients with Psoriatic Arthritis (PsA) Study #1634801 Synopsis 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. Study Team Local PI: Priyanka Murali, MD Sarah Crim [email protected] 727-398-6661, ext. 17975 Camille Compton [email protected] 727-398-6661, ext. 14728 or 10151 Status Enrolling Study Area Cardiology Title/BP Study Number Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults (PREVENTABLE) Trial Study #1612747 Synopsis 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 Study Team Local PI: Dennis Hall Chayla Lee [email protected] 727-398-6661, ext. 10111 Cortny Withee [email protected] 727-398-6661, ext. 15900 Status Enrolling Study Area Infectious Disease Title/BP Study Number CSP #2001 Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA INTREPID) Study #1613455 Synopsis 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 Study Team Local PI: Melissa Abercrombie, MD Cortny Withee [email protected] 727-398-6661, ext. 15900 Sarah Crim [email protected] 727-398-6661, ext. 17975 Status Enrolling Study Area Infectious Disease Title/BP Study Number CSP #596 Optimal Treatment for Recurrent Clostridium difficile Infection (OpTION) Study #1613094 Synopsis 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: NCT02667418 Study Team Local PI: Kaley Tash, MD Cortny Withee [email protected] 727-398-6661, ext. 15900 Sarah Crim [email protected] 727-398-6661, ext. 17975 Status Enrolling Study Area Cardiology Title/BP Study Number CSP2002 VA-IMPACT Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes Study #TBD Synopsis 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). Study Team Local PI: Manjunath Harlapur, MD Stella Inting-Toothman (727) 398-6661, ext. 17184 (727) 776-8687 [email protected] Sarah Crim [email protected] 727-398-6661, ext. 17975 Status To be launched Study Area Lung Cancer Title/BP Study Number LungLife AI Inc. Study #1651410 Synopsis 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 Study Team Local PI: Stephen Clum, MD Camille Compton [email protected] 727-398-6661, ext. 10151 Mariah Alexis [email protected] 727-398-6661, ext. 10152 Kameron Wheelock [email protected] 727-398-6661, ext. 17842 Status Enrolling Study Area Prostate Cancer Title/BP Study Number Identification of Targetable Prostate Cancer Alterations Through Tumor DNA Screening Study #1573965 Synopsis 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. Study Team Local PI: Ryan Burri, MD Hayley Maither [email protected] 727-398-6661, ext. 15925 Kameron Wheelock [email protected] 727-398-6661, ext. 17842 Mariah Alexis [email protected] 727-398-6661, ext. 10152 Status Enrolling Study Area Prostate Cancer Title/BP Study Number 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 Synopsis 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. Study Team Local PI: Ryan Burri, MD Hayley Maither [email protected] 727-398-6661, ext. 15925 Kameron Wheelock [email protected] 727-398-6661, ext. 17842 Status Enrolling Study Area Lung Cancer Title/BP Study Number 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 Synopsis 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. Study Team Local PI: Ryan Burri, MD Kameron Wheelock [email protected] 727-398-6661, ext. 17842 Hayley Maither [email protected] 727-398-6661, ext. 15925 Status Enrolling Study Area Bladder Cancer Title/BP Study Number 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 Synopsis 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). Study Team Local PI: Andrew Leone, MD Hayley Maither [email protected] 727-398-6661, ext. 15925 Kameron Wheelock [email protected] 727-398-6661, ext. 17842 Status Enrolling Study Area Lung Cancer Title/BP Study Number A Phase 2 Trial of MRTX849 Monotherapy and in Combination with Pembrolizumab in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation Study #1679339 Synopsis This is a study assessing the efficacy and safety of MRTX849 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). Study Team Local PI: Ryan Burri, MD Kameron Wheelock [email protected] 727-398-6661, ext. 17842 Hayley Maither [email protected] 727-398-6661, ext. 15925 Mariah Alexis [email protected] 727-398-6661, ext. 10152 Status Enrolling Study Area Bladder Cancer Title/BP Study Number 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 Synopsis 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. Study Team Local PI: Andrew Leone, MD Mariah Alexis [email protected] 727-398-6661, ext. 10152 Hayley Maither [email protected] 727-398-6661, ext. 15925 Kameron Wheelock [email protected] 727-398-6661, ext. 17842 Status To be launched Study Area Head and Neck Cancer Title/BP Study Number 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) Clinical Trials: NCT05050162. Study #1682403 Synopsis 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. Study Team Local PI: Ryan Burri, MD Hayley Maither [email protected] 727-398-6661, ext. 15925 Kameron Wheelock [email protected] 727-398-6661, ext. 17842 Mariah Alexis [email protected] 727-398-6661, ext. 10152 Status Enrolling Study Area Prostate Cancer Title/BP Study Number A Single-arm, Open-label, Phase II Study of Checkpoint Inhibitors in Men with Progressive Metastatic Castrate Prostate Cancer (mCRPC) Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation (CHOMP). Study #1612473 Synopsis The purpose of this study is to determine the response rate to the anti-PD1 antibody, pembrolizumab in Veterans with mCRPC characterized by either mismatch repair deficiency (dMMR) or biallelic inactivation of CDK12. Study Team Local PI: Ryan Burri, MD Hayley Maither [email protected] 727-398-6661, ext. 15925 Kameron Wheelock [email protected] 727-398-6661, ext. 17842 Status Enrolling Study Area Prostate Cancer Title/BP Study Number 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 (COBRA). Study #1612483 Synopsis 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. Study Team Local PI: Ryan Burri, MD Kameron Wheelock [email protected] 727-398-6661, ext. 17842 Hayley Maither [email protected] 727-398-6661, ext. 15925 Status Enrolling Study Area Prostate Cancer Title/BP Study Number VA Multi-Omics Analysis Platform for Prostate Cancer and Sequencing (VA MAPP-SEQ) Biorepository Study #1713735 Synopsis 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. Study Team Local PI: Andrew Leone, MD Hayley Maither [email protected] 727-398-6661, ext. 15925 Kameron Wheelock [email protected] 727-398-6661, ext. 17842 Mariah Alexis [email protected] 727-398-6661, ext. 10152 Status Enrolling Study Area Pulmonary/COPD Title/BP Study Number 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 MEDI3506 in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (TITANIA). Study #1672631 Synopsis 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 MEDI3506 300 mg every 8 weeks and 300 mg every 4 weeks dose regimens. The study is to be conducted. Study Team Local PI: Ravi Patel, MD Sarah Crim [email protected] 727-398-6661, ext. 17975 Lori Camille Compton [email protected] 727-398-6661, ext. 10151 Chayla Lee [email protected] 727-398-6661, ext. 10111 Status Enrolling Study Area Cardiology Title/BP Study Number A Multi-Center Study Evaluating Participants who Received CanGaroo® Envelope, TYRX™ Envelope, or No Envelope During CIED Implantation. Study #1605396 Synopsis 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: NCT04645173 Study Team Local PI: Afolabi Sangosanya, MD Cortny Withee [email protected] 727-398-6661, ext. 15900 Lori Camille Compton [email protected] 727-398-6661, ext. 10151 Chayla Lee [email protected] 727-398-6661, ext. 10111 Status Enrolling