Bay Pines VA Research Program

Title: "ReplaceCysto" Replacing Invasive Cystoscopy with Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance (National Cancer Institute) Study # 1838272

Synopsis: The study aims to determine if urine-based surveillance can improve the quality of life and reduce discomfort compared to traditional cystoscopy. 

Clinical Trial: NCT05796375

Study Team: Local PI: Andrew Leone, MD

Anna Rosenblatt 
Anna.Rosenblatt2@va.gov 
ension17051 or

Status: Enrolling

Title: PREVENTABLE- Pragmatic Evaluation of Events and Benefits of Lipid-Lowering in Older Adults 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 Trial: NCT04262206

Study Team: Local PI: Dennis Hall

Anna Rosenblatt 
Anna.Rosenblatt2@va.gov 
ension 17051 or

Status: Enrolling

Title: VA-IMPACT- Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular Out comes. VA CSP #2002 Study #1612520

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)

Clinical Trial: NCT02915198

Study Team: Local PI: Manjunath Harlapur, MD

Sarah Crim 
Sarah.Crim@va.gov
ension 17975

Elizabeth Lockaby 
Elizabeth.Lockaby@va.gov 
ension 15147

Status: Enrolling

Title: VA- B3C-Basal Cell Carcinoma Chemoprevention Trial (B3C). Efficacy of Imiquimod for the prevention of Basal Cell Carcinomas VA CSP #2019 Study # 1743196

Synopsis: This is an intent-to-treat, parallel design, multicenter randomized trial and the primary intervention is a double-blind comparison of Imiquimod (IMQ) vs. placebo cream for preventing basal cell carcinoma (BCC) of the skin on the face at one year and over 3 years after therapy. Participants will apply the IMQ or placebo cream to the face daily at bedtime for 12 weeks. This study will recruit 1630 Veterans at high risk of BCC from 17 VA medical centers. 

Clinical Trial: NCT05212246

Study Team: Local PI: Daniel Hogan, MD

Lori Sisler 
Lorine.Sisler@va.gov
ension 17596

Status: Enrollment Pending

Title: VA INTREPID- Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics VA CSP #2001 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 Trial: NCT03012529

Study Team: Local PI: Melissa Abercrombie, MD

Sarah Crim 
Sarah.Crim@va.gov
ension 17975

Status: Enrolling

Title: VA PTXRx- Pentoxifylline in Diabetic Kidney Disease VA CSP# 2008 Study # 1707595

Synopsis: Compare the time until End Stage Renal Disease or death between participants randomized to Pentoxifylline (PTX) or placebo. 

Clinical Trial: NCT03625648

Study Team: Local PI: Hemalatha Gutta, MD

Lori Sisler
Lorine.Sisler@va.gov

ension 17596

Elizabeth Lockaby 
Elizabeth.Lockaby@va.gov 
ension 15147

Status: Enrolling

Title: 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

Synopsis: 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

Study Team: Local PI: Melissa Abercrombie, MD

Ashlee Tavernier 
Ashlee.Tavernier@va.gov
ension 17842

Sarah Crim 
Sarah.Crim@va.gov
ension 17975

Status: Enrolling

Title: MVP- Million Veteran Program 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 only blood collection project. 

Clinical Trial: NCT04178122

Study Team: Local PI: Daniel Hogan, MD

Status: On Hold

Title: NRG-CC005-FORTE- Five- or Ten-Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps Study #1746496

Synopsis: 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

Study Team: Local PI: Ryan Burri, MD

Rachel Sullivan 
Rachel.Sullivan@va.gov
ension 10111

Anna Rosenblatt 
Anna.Rosenblatt2@va.gov 
ension 17051 or

Status: Enrolling

Title: 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

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. 

Clinical Trial: NCT05050162

Study Team: Local PI: Ryan Burri, MD

Ronald Eland 
Ronald.Eland@va.gov
ension 15925

Anna Rosenblatt 
Anna.Rosenblatt2@va.gov 
ension 17051 or

Status: Enrolling

Title: RSV-HR-A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of EDP-938 in Non-hospitalized Adults with Acute Respiratory Syncytial Virus Infection who are at High Risk for Complications Study #1852330

Synopsis: The purpose of this trial is to evaluate safety and efficacy of a 5-day course of an investigational oral antiviral for non-hospitalized Veterans who are high risk and test positive for RSV. 

Clinical Trial: NCT05568706

Study Team: Local PI: Stephen Clum, MD

Sarah Crim 
Sarah.Crim@va.gov
ension 17975

Anna Rosenblatt 
Anna.Rosenblatt2@va.gov 
ension 17051 or

Status: Enrolling

Title: CON-1 A Randomized, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Treatment With MNKD-101 (Clofazimine Inhalation Suspension) When Added to Guideline-Based Therapy in Participants with Pulmonary Nontuberculous Mycobacterial Infection (Part A) Followed by an Open-Label Extension (Part B) Study # 1818430

Synopsis: The Sponsor, MannKind, is developing an inhaled suspension of clofazimine, MNKD-101, to be delivered directly to the site of infection in the lungs via a jet nebulizer. The purpose of the trial is to evaluate the efficacy and safety of treatment with Clofazimine Inhalation Suspension when added to regular therapy in participants with pulmonary nontuberculous mycobacterial infection followed by an open-label extension. 

Clinical Trial: NCT06418711

Study Team: Local PI: Leigh Medaris, MD

Sarah Crim 
Sarah.Crim@va.gov
ension 17975 

Elizabeth Lockaby 
Elizabeth.Lockaby@va.gov 
ension 15147

Status: Enrolling

Title: KRASCENDO-1- A Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of divarasib versus sotorasib or adagrasib in patients with previously treated KRAS-G12C-positive advanced or metastatic non-small cell lung cancer Study # 1845548

Synopsis: The purpose of this study is to assess the efficacy and safety of divarasib, KRAS G12C inhibitor, compared to locally approved KRAS-G12C inhibitors (sotorasib or adagrasib) in patients with KRAS-G12C positive advanced or metastatic NSCLC who have been previously treated with standard of care treatments in the advanced or metastatic setting. 

Clinical Trial: NCT06497556

Study Team: Local PI: Harsh Bhushan, MD

Ronald Eland 
Ronald.Eland@va.gov
ension 15925 

Elizabeth Lockaby 
Elizabeth.Lockaby@va.gov 
ension 15147

Status: Enrolling

Title: ARTEMiDE-Lung-02- A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line treatment of Patients with Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) whose tumors express PD-L1 (ARTEMIDE-Lung02) (AstraZeneca) Study # 1849539

Synopsis: The purpose of this research is to learn more about the investigational study drug, rilvegostomig (also called AZD2936), and compares the effectiveness and safety of rilvegostomig plus chemotherapy to that of a standard treatment for metastatic squamous NSCLC (pembrolizumab plus chemotherapy). This study is also testing the effectiveness of the diagnostic test used to assess the biomarker PD-L1 to identify metastatic squamous NSCLC participants most likely to benefit from treatment with rilvegostomig in combination with chemotherapy. 

Clinical Trials: NCT06692738

Study Team: Local PI: Harsh Bhushan, MD

Ronald Eland 
Ronald.Eland@va.gov
ension 15925 

Elizabeth Lockaby 
Elizabeth.Lockaby@va.gov 
ension 15147

Status: Enrollment Pending

Title: ARTEMiDE-Lung-03-- A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line treatment of Patients with Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) whose tumors express PD-L1 (ARTEMIDE-Lung03) (AstraZeneca) Study # 1849541

Synopsis: The purpose of this research is to learn more about the investigational study drug, rilvegostomig (also called AZD2936), and compares the effectiveness and safety of rilvegostomig plus chemotherapy to that of a standard treatment for metastatic non-squamous NSCLC (pembrolizumab plus chemotherapy). This study is also testing the effectiveness of the diagnostic test used to assess the biomarker PD-L1 to identify metastatic non-squamous NSCLC participants most likely to benefit from treatment with rilvegostomig in combination with chemotherapy. 

Clinical Trial: NCT06627647

Study Team: Local PI: Harsh Bhushan, MD

Ronald Eland 
Ronald.Eland@va.gov
ension 15925 

Elizabeth Lockaby 
Elizabeth.Lockaby@va.gov 
ension 15147

Status: Enrollment Pending

Title: VALOR-Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy Trial. VA 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 Trial: NCT02984761

Study Team: Local PI: Edward Hong, MD

Ronald Eland 
Ronald.Eland@va.gov
ension 15925 

Elizabeth Lockaby 
Elizabeth.Lockaby@va.gov 
ension 15147

Status: Enrolling

Title: NIGHTINGALE: CliNIcal Utility of ManaGement of Patients witH CT and LDCT Identified Pulmonary Nodules UsinG the Percepta NasAL Swab ClassifiEr – with Familiarization (Veracyte Inc) Study #1725444

Synopsis: 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 Trial: NCT06426628

Study Team: Local PI: Stephen Clum, MD

Ronald Eland 
Ronald.Eland@va.gov
ension 15925 

Elizabeth Lockaby 
Elizabeth.Lockaby@va.gov 
ension 15147

Status: Enrolling

Title: 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 (Bristol Myers-Squibb) Study #1679339

Synopsis: 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

Study Team: Local PI: Ryan Burri, MD

Ronald Eland 
Ronald.Eland@va.gov
ension 15925 

Elizabeth Lockaby 
Elizabeth.Lockaby@va.gov 
ension 15147

Status: Enrolling

Title: AMPLITUDE- A phase II/III Adaptive Study of VX-147-301 in Adult and Pediatric Participants with APOL1- Mediated Proteinuric Kidney Disease Study # 1712458

Synopsis: Phase II/III Trial Investigating use of VX-147 in Adults with APOL-1 Mediated Chronic Kidney Disease to evaluate the efficacy and safety of VX-147 to reduce proteinuria and improve renal function 

Clinical Trial: NCT05312879

Study Team: Local PI: Chandana Reddy, MD

Anna Rosenblatt 
Anna.Rosenblatt2@va.gov 
ension 17051 or

Status: Enrolling

Title: 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

Synopsis: 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 Trial: NCT06291376

Study Team: Local PI: Ashwinikumar Patil, MD

Anna Rosenblatt 
Anna.Rosenblatt2@va.gov 
ension 17051 or

Status: Enrolling

Title: VA BRAVE- Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans VA CSP# 2014 Study # 1573941

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 Trial: NCT04375033

Study Team: Local PI: Maha Lahoud-Bladykas, MD

Chris Vallanat 
Christopher.Vallanat@va.gov 
ension 15992

Status: Enrolling

Title: 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

Synopsis: 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 Trial: NCT04513717

Study Team: Local PI: Ryan Burri, MD

Ronald Eland 
Ronald.Eland@va.gov
ension 15925

Ashlee Tavernier 
Ashlee.Tavernier@va.gov 
ension 17842

Status: Enrolling

Title: 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

Synopsis: 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 Trial: NCT05050084

Study Team: Local PI: Ryan Burri, MD

Ronald Eland 
Ronald.Eland@va.gov
ension 15925

Ashlee Tavernier 
Ashlee.Tavernier@va.gov 
ension 17842

Status: Enrolling

Title: 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 (VA Clinical Sciences and Research & Development) 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. 

Clinical Trial: NCT04787744

Study Team: Local PI: Ryan Burri, MD

Ronald Eland 
Ronald.Eland@va.gov
ension 15925

Ashlee Tavernier 
Ashlee.Tavernier@va.gov 
ension 17842

Status: Enrolling

Title: VA MAPP- VA Multi-Omics Analysis Platform for Prostate Cancer and Sequencing Biorepository (Prostate Cancer Foundation) 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

Ronald Eland 
Ronald.Eland@va.gov
ension 15925

Ashlee Tavernier 
Ashlee.Tavernier@va.gov 
ension 17842

Status: Enrolling

Title: 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

Synopsis: 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 Trial: NCT04104893

Study Team: Local PI: Ryan Burri, MD

Ronald Eland 
Ronald.Eland@va.gov
ension 15925

Ashlee Tavernier 
Ashlee.Tavernier@va.gov 
ension 17842

Status: Enrolling

Title: ONCOMINE- 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

Ronald Eland 
Ronald.Eland@va.gov
ension 15925

Ashlee Tavernier 
Ashlee.Tavernier@va.gov 
ension 17842

Status: Enrolling

Title: 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

Synopsis: 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 Trial: NCT04929210

Study Team: Local PI: Priyanka Murali, MD

Sarah Crim 
Sarah.Crim@va.gov
enstion 17975

Status: Enrolling