FIRST-Assisted Studies

Active Projects Supported by FIRST Program

Research Protocols

Hover over each project to view a description.

Principal Investigator Division IRB No. Title Status ClinicalTrials.gov
Brat, GabrielThe purpose of this protocol is to create a data repository to capture post-surgical opioid use following discharge. This repository synthesizes data from two previously IRB approved studies, Creating a National Resource for Opioid Prescribing Across Surgical Specialties (2017P-000304) and A Text Messaging System to Provide Sustainable Post-Discharge Surgical Opioid Use Data (2018P-000442), for use in potential future research.
Acute Care Surgery, Trauma, and Surgical Critical Care 2019P001126 Opioid Collaborative Consumption and Prescription Repository Active; Data Collection NA
Brat, GabrielIn this study, the investigators use previously collected data on IBD patients at BIDMC and pair this with billing data to form a new “administrative” definition of an IBD flare. Following this the investigators will validate this definition in a much larger database as well as use this larger database to look for potential triggers.
Acute Care Surgery, Trauma, and Surgical Critical Care 2019P000019 Defining inflammatory bowel disease (IBD) flare in administrative data and identifying triggers in administrative databases Active; Data Collection NA
Brat, GabrielIn this study, the investigators plan to use a patient’s preoperative data to quantify their personal risk associated with a specific surgical intervention and create an interactive visual tool that allows the patient to prioritize outcomes and help guide the conversation during the consenting process. This interactive tool will provide a setting that facilitates the patient and surgeon to engage in shared decision making (SDM). They hypothesize that this personalized visualization tool will lead to improved patient understanding and overall satisfaction.
Acute Care Surgery, Trauma, and Surgical Critical Care 2019P000013 Improving patient understanding using visualization in the surgical consent process Active; Recruiting NA
Brat, GabrielThe purpose of this project is to continue to identify the quantity of opioids required for the typical post-operative patient after discharge from the hospital. In the investigator’s previously submitted IRB protocol, 2017P-000304, patients were called by phone to complete a postoperative pain survey and ~3,000 patients have been enrolled to date. This data has been revealing, however, in order to increase patient participation and broaden applicability, this protocol will utilize a voluntary online survey sent via text message to BIDMC patients.
Acute Care Surgery, Trauma, and Surgical Critical Care 2018P000442 A Text Messaging System to Provide Sustainable Post-Discharge Surgical Opioid Use Data Active; Recruiting NA
Brat, GabrielThe proposed study is a chart review to analyze the surgical patients at BIDMC from the years 2007-2020 in order to evaluate opioid prescribing practices across all patients. The investigator’s hope to define the range of prescribing habits among clinicians across care settings, peri-operative risk factors for opioid misuse, and frequency of refills of opioid medications. The aim of the project is to tie opioid prescribing behaviors and the clinical pathology to the downstream requirements for opioid and other pain medication use.
Acute Care Surgery, Trauma, and Surgical Critical Care 2018P000226 Defining Drivers of Peri-operative Opioid Use at BIDMC Active; Recruiting NA
Brat, GabrielThe purpose of this project is to identify the quantity of opioids required for the typical post-operative patient after discharge for a subset of the most common ~50 surgical procedures. The investigators will then establish a resource to guide prescribers on typical opioids required for postoperative pain management. Therefore, by establishing a resource for the average amount of opioids required for ~50 surgical procedures, physicians can more accurately prescribe for their patients and decrease the risk of drug dependence and drug diversion.
Acute Care Surgery, Trauma, and Surgical Critical Care 2017P000304 Creating a National Resource for Opioid Prescribing Across Surgical Specialties Active; Recruiting NA
Cook, CharlesElezanumab is an investigational product under development for improvement of neurological function in patients with acute SCI. Treatment of SCI patients with elezanumab has the potential to enhance recovery and provide a more complete or better recovery by promoting neurorestoration that, in addition to standard of care, may make a significant positive impact on patients’ overall quality of life.
Acute Care Surgery, Trauma, and Surgical Critical Care 2020P001131 A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury (M16-077) Pending IRB Approval NCT04295538
Itagaki, KiyoshiThis study investigates the use of advanced microscopy techniques in diagnosing prostate diseases using freshly excised tissue and then compares the results to traditional microscopic diagnosis techniques.
Acute Care Surgery, Trauma, and Surgical Critical Care 2019P000243 Prevention of Nosocomial Pneumonia after Serious Injury Active; Recruiting NA
Adra, SouheilIn this study, the investigators use gamification strategies to incorporate game design elements into robotic simulator training with weekly leaderboards, assignments with time constraints as well as progress bars. The goal of this study is to identify important factors of a robotic training curriculum that may stimulate increased participation and continuous training on the robotic simulator.
Bariatric and Minimally Invasive Surgery 2020P001056 Effect of Gamification of Robotic Simulation Training on Simulator Usage and Performance Active; Recruiting NA
Cataldo, ThomasThe goal of this study is to examine if prescribing blood thinners to all patients has lowered the rate of clots and if patients are taking this medication by analyzing previously collected data from a QI database.
Colon and Rectal 2018P000772 Extended Use of Lovenox in Post Colectomy Thromboembolic Event Prevention Active; Data Analysis NA
Cataldo, ThomasThis study is a retrospective study of patients with anatomic stage II, MMR-P and stage III A/B colon cancers who underwent 12 gene Oncotype DX Colon Recurrence Score. The goal of the study is to determine how the score influenced treatment and clinical outcomes.
Colon and Rectal 2018P000745 Influence of 12 Gene Recurrence Score on Clinical Decision Making Active; Data Analysis NA
Fabrizio, AnneThe purpose of this study is to evaluate the safety and effectiveness of an investigational device, the CG-100 Intraluminal Bypass Device, in reducing the need for a diverting stoma in patients undergoing mesorectal excision and anastomosis as standard of care.
Colon and Rectal Pending Efficacy and Safety of the CG-100 Intraluminal Bypass device in Colorectal and Coloanal Anastomoses: Prospective, Open Label, Randomized trial Pending IRB Approval NCT04184973
Messaris, EvangelosThis study is a pilot prospective study of Therapeutic Response Predictor Assay (TheRPA) bioassay in a cohort of patients with Acute Severe Ulcerative Colitis undergoing inpatient rescue therapy with Infliximab to determine the feasibility and effectiveness of TheRPA in predicting short-term failure of salvage Infliximab treatment.
Colon and Rectal 2020P000998 Acute Severe Ulcerative Colitis: A Novel Approach to Identify Patients in Need for Early Surgical Resection (UC-PREDICT) Active; Not Yet Recruiting NA
Messaris, EvangelosThis study is a randomized, prospective trial investigating the timing of diverting ileostomy closure after ileal j-pouch surgery.
Colon and Rectal 2018P000653 Short Versus Long Interval to Loop Ileostomy Reversal After Ileal Pouch Surgery in Patients with Ulcerative Colitis (SLIRPS) Trial Active; Not Recruiting NCT03587519
Messaris, EvangelosThe purpose of this study is to evaluate the combined remission of complex perianal fistulas, defined as the clinical assessment at Week 24 of closure of all treated external openings that were draining at baseline despite gentle finger compression, and absence of collections greater than (>) 2 centimeter (cm) (in at least 2 dimensions) confirmed by blinded central magnetic resonance imaging (MRI) assessment at Week 24.
Colon and Rectal 2020P000314 A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula( Active; Recruiting NCT03279081
Cummings, RichardThis protocol uses newly collected tissue (from pre-operative clinical biopsy samples and discarded surgical specimens) and blood to evaluate glycans and proteoglycans that may be early detection biomarkers for colorectal adenocarcinoma.
General Surgery 2018P000691 Proteoglycomic Analysis of Colorectal Cancer Active; Recruiting NA
Kent, TaraThe purpose of this study is to study how residents interact with the rest of the healthcare team to treat a patient who has undergone a major complication.
General Surgery 2014P000299 Surgical residents role in escalating care and rescuing patients Active; Data Analysis NA
Kent, TaraThe aim of this study is to conduct a prospective study involving distribution of patient surveys to assess attitudes towards the current discharge process and the potential role of a future tablet application to supplement the discharge process. Furthermore, the postoperative quality of life of patients is being evaluated.
General Surgery 2014P000051 Patient perceptions of the Institute of Hepatobiliary and Pancreatic Surgery postoperative hospital discharge process Active; Data Analysis NA
Kent, TaraThis project seeks to examine perioperative care and postoperative outcomes in major pancreatico-biliary surgery. The aim is to evaluate the impact of a clinical pathway on rates of complications, length of stay, hospital costs, and survival through a retrospective medical record review.
General Surgery 2005P000231 Outcomes Analysis in Major Pancreatico-Biliary Procedures Active; Data Analysis NA
Qureshi, AliaThis study aims to examine the phosphoproteomic profile of esophageal cells of patients with Barrett’s esophagus or Barrett’s with dysplasia. From this, it is hoped that a protein marker will be identified that indicates whether or not the patient will progress along the BE pathway.
General Surgery 2017P000203 Barrett’s Esophagus Pilot Study Active; Data Analysis NA
Moore, JustinThe goal of this study is to delineate the underlying mechanism leading to aneurysm development, progression, rupture and vasospasm, which will later help in identifying targets which are amenable to intervention.
Neurosurgery 2017P000334 The genetic and epigenetic basis of intracerebral aneurysms Active; Recruiting NA
Moore, JustinThis study is designed to study patients’ medical records who are admitted to Neurosurgery with subarachnoid hemorrhage. Symptoms and outcomes will be studied to analyze predictive values of symptoms and patient demographics, as well as best course of treatment
Neurosurgery 2016P000267 Neurosurgery Subarachnoid Hemorrhage Database Active; Data Collection NA
Stippler, MartinaBOOST-3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone.
Neurosurgery 2019C000117 Brain Oxygen Optimization in Severe Traumatic Brain Injury—Phase 3 Active; Recruiting NCT03754114
Stippler, MartinaThis study is to review patients in the BIDMC TBI database from 2016 to present who presented while on inappropriate anticoagulant use. Inappropriate use is here defined as use that is not indicated based on past medical history. The goal of this review is to see how inappropriate use impacts outcomes of TBI in comparison to patients that were not on anticoagulants.
Neurosurgery 2020P000607 Prevalence of unnecessary antithrombotic use in Traumatic Brain Injury Active; Data Analysis NA
Stippler, MartinaThe Traumatic Injury Database is a registry of all traumatic brain injury patients over the age of 18 years old who have been treated at BIDMC for both surgical and non-surgical interventions. The purpose of this database is to collect data of TBI patients from January 2014 on, and will help us learn more about this population and what factors lead to better or worse outcomes.
Neurosurgery 2016P000233 Traumatic Injury Database Active; Data Collection NA
Thomas, AjithThe EVOLVE study is a prospective, multi-center, single-arm, open-label, international clinical study of an investigational device, the Surpass Evolve Flow Diverter System, in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the internal carotid artery (ICA) or its branches.
Neurosurgery 2020P000752 The EndoVascular Treatment Of Wide-Neck Aneurysms for the EvaLuation of Safety and EffectiVeness of Surpass Evolve™ Flow Diverter System (EVOLVE) Trial Pending IRB Approval NCT03873714
Thomas, AjithThe goal of this study is to determine the efficacy of intravenous study drug clazosentan in preventing clinical deterioration in subjects with arterial subarachnoid hemorrhage. Patients are randomized to study drug or placebo and followed for 180 days to assess clinical and behavioral status and safety.
Neurosurgery 2018P000654 A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the efficacy and safety of clazosentan in preventing clinical deterioration due to delayed cerebral ischemia (DCI), in adult subjects with a Active; Not Yet Recruiting NCT03585270
Thomas, Ajith
Neurosurgery 2018P000415 Intracranial Pressure Assessment and Screening System (IPASS) Active; Not Yet Recruiting NA
Thomas, AjithThe goal of this study is to determine the association between iron levels in the brain and CSF with rates of delayed hydrocephalus (dHCP). The identification of a correlation between iron levels in brain and CSF and hydrocephalus in humans might lead to better understanding of the pathophysiology and a proposal for novel treatments.
Neurosurgery 2017P000434 Iron Hydrocephalus SAH study (IHSAH study) Active; Recruiting NA
Thomas, AjithThe purpose of this study is to evaluate the safety and the effectiveness of the Neuroform Atlas™ Stent System for use with bare metal embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of ≥ 2 mm and ≤ 4.5 mm.
Neurosurgery 2015P000153 Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms with the Neuroform Atlas™ Stent System Active; Long-Term Follow-Up NCT02340585
Thomas, AjithThis research protocol aims to create a database registry of all cerebrovascular patients at BIDMC. This would include all patients treated with a diagnostic cerebral angiogram, any neuro-interventional procedure, or open cerebrovascular procedure and also will include patients who do not have treatment.
Neurosurgery 2014P000377 Cerebrovascular Neurosurgical Database Active; Data Collection NA
Thomas, AjithThe goal of this protocol is to create a repository to evaluate the various contributing factors related to the development, diagnosis and management of patients undergoing various neurosurgery procedures, and to analyze their outcomes.
Neurosurgery 2013P000253 Evaluation of Outcomes Following Neurosurgery Procedures Active; Data Collection NA
You, JaeThe objective of the Zoster Eye Disease Study (ZEDS) is to determine whether prolonged suppressive oral antiviral treatment with valacyclovir reduces complications of Herpes Zoster Ophthalmicus (HZO), thereby improving clinical outcomes in this common and potentially vision- and life-threatening disease. There are 1,000,000 new cases of Herpes Zoster (HZ) per year in the USA, with 10-20% being HZO.
Ophthalmology 2019C001008 ZEDS: Zoster Eye Disease Study Active; Recruiting NCT03134196
Gomez, ErnestThis study aims to compare the effects of nasal mist calcium salts to normal saline on exhaled bioaerosol count in healthy patients. Respiratory droplets and aerosols are the suspected mode of transmission for SARS-CoV-2. We hypothesize that subjects who inhale calcium salts will produce a significantly lower exhaled bioaerosol particle count than subjects who inhale saline.
Otolaryngology Pending Effect of Inhaled Calcium Salts on Exhaled Bioaerosols Pending IRB Approval NA
Lee, BernardThis study is a retrospective medical record review to determine the readability and suitability of provider notes of patients at BIDMC enrolled in the OpenNotes program.
Plastic & Reconstructive Surgery 2019P000791 Improving Patient Physician Communication in an OpenNotes Environment Active; Data Collection NA
Singhal, DhruvThe purpose of this protocol is to create a biorepository containing samples from patients who are undergoing lymphatic surgery at Beth Israel Deaconess Medical Center. We plan to use the Lymphedema Surgery Biorepository for future research to study lymphatic structure as well as to identify genes, biomarkers, or biological processes associated with lymphedema.
Plastic & Reconstructive Surgery 2017P000190 Lymphedema Surgery Biorepository Active; Recruiting NA
Singhal, DhruvThe purpose of this protocol is to create a video repository containing videos of diagnostic imaging of patients who are receiving lymphedema workup at Beth Israel Deaconess Medical Center. We plan to have these videos processed in order to correlate imaging findings with lymphatic function.
Plastic & Reconstructive Surgery 2017P000302 Lymphedema Surgery Video Repository Active; Recruiting NA
Singhal, DhruvThis study aims to validate the use of a new device called a lymphedema indentometer or durometer in diagnostic workup for lymphedema
Plastic & Reconstructive Surgery 2017P000378 Acupuncture for Breast Cancer Related Lymphedema: A Pilot Study Active; Recruiting NCT03313999
Singhal, DhruvThe goal of this study is to demonstrate the feasibility of performing acupuncture for breast cancer related lymphedema (BCRL) while beginning to explore the mechanistic underpinnings of this treatment. Specifically, we will conduct a randomized, unblinded, proof-of-concept pilot study offering patients with unilateral BCRL a 6-week acupuncture intervention with unprecedented rigorous monitoring of the affected upper extremity and the systemic response.
Plastic & Reconstructive Surgery 2017P000433 Measuring Skin Elasticity in Lymphedema Patients Active; Not Recruiting NA
Singhal, DhruvThe purpose of this study is to evaluate for potential proteomic markers in patients that have developed breast cancer-related lymphedema. Our goal is to evaluate circulating proteins that may differ between patients with and without breast cancer-related lymphedema after undergoing similar treatment. Differences in protein levels can assist as both biomarkers to evaluate who may be at risk for the development of lymphedema, but also in better understanding the underlying mechanisms of lymphedema.
Plastic & Reconstructive Surgery 2018P000320 Circulating Proteins in Breast Cancer-Related Lymphedema Active; Recruiting NA
Singhal, DhruvThis pilot randomized controlled trial is designed to examine the usual anatomy of lymphatic drainage of tissue involved in microvascular breast reconstruction using intraoperative and postoperative indocyanine green lymphangiography (ICG LA). With knowledge of the usual drainage patterns, we will examine the pattern and time course of lymphatic reconstitution after flap transfer in patients undergoing DIEP flap transfer for breast reconstruction.
Plastic & Reconstructive Surgery 2019P000733 Lymphatic Reconstitution in Microvascular Breast Reconstruction Active; Not Recruiting NA
Singhal, DhruvSoft tissue infection is a well-established complication of chronic lymphedema. However, there is research showing that such infections can contribute to the development of lymphedema. The purpose of this research study is to investigate the underlying mechanism of soft tissue infection and its link to lymphedema. With the cooperation of Dr. Dennis Jones at Boston University, the research team intends to analyze human lymphatic tissue samples from patients with varying medical histories for histologic changes caused by infections previously characterized in mouse models.
Plastic & Reconstructive Surgery 2020P000822 The mechanism of infection secondary to lymphedema: establishing the link between soft tissue infection and lymphatic dysfunction in human tissue Active; Data Analysis NA
Singhal, DhruvNo one has yet successfully identified a biomarker that is specific to lymphedema and could be used to predict which patients may go on to develop lymphedema. The purpose of this protocol is to use samples collected from patients who have developed chronic lymphedema, or who have undergone a high-risk operation (axillary lymph node dissection), to systematically categorize cell lines in fat tissue samples and possibly find biomarkers indicative of the disease process. We hope to analyze the specific make-up of fat and lymphatic tissue that is taken from a lymphedematous extremity, which we know from prior studies is different histologically from normal fat and lymphatics, but has largely been studied in animal models.
Plastic & Reconstructive Surgery 2020P000827 Gene Expression in Fat Tissue Samples from the Lymphatic Surgery Biorepository Active; Data Analysis NA
Singhal, DhruvBreast cancer related lymphedema affects 1.2 million patients in the U.S. and is one of the most significant cancer survivorship burdens. Our proposed research study aims to identify normal variations in lymphatic anatomy and function that predispose women to lymphedema.
Plastic & Reconstructive Surgery Pending Variable anatomy & function of the arm’s alternate lymphatic pathway Pending IRB Approval NA
Dinh, ThanhThis study is a medical record review to define a standardized radiographic measurement of intercuneiform gapping and evaluate its presence following Lapidus bunionectomy.
Podiatry 2018P000526 The incidence of intercuneiform gapping following Lapidus bunionectomy Active; Data Collection NA
James, TedThe main study objective is to conduct a stepped wedge hybrid effectiveness-implementation trial at six health systems in Boston caring for minority, low-income women with breast cancer to assess clinical effectiveness and implementation of the integrated intervention.
Surgical Oncology 2018C000059 Translating Research in Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care Active; Recruiting NCT03514433
Rodrigue, JamesEvaluate the differential benefit of adding a patient-centered peer mentorship component to the House Calls intervention. In a randomized controlled trial, we will compare Usual Care (UC) to House Calls (HC) alone to House Calls + Peer Mentorship (HC+PM) in a sample of black ESRD patients.
Transplantation 2017P000521 Comparing the Effectiveness of House Calls and Peer Mentorship to Reduce Racial Dispartities in Live Donor Kidney Transplantation Active; Data Analysis NCT03354910
Rodrigue, JamesAccess adult HCV- kidney and liver transplant candidates’ knowledge, willingness, and concerns about HCV+/HCV- transplantation. To evaluate the effectiveness of a physician-led education session on patient perceptions about HCV+/HCV- kidney transplantation.
Transplantation 2018P000753 Transplantation of Hepatitis-C positive Kidneys into Hepatitis-C Negative Patients: Knowledge, Willingness and Concerns among Transplant Candidates Pending IRB Approval NA
Rodrigue, JamesVascularized composite allograft (VCA) transplantation of the face, extremities, and genitourinary organs (e.g., uterus, penis) returns identity and function to individuals affected by traumatic injury, congenital deformity, or disfigurement. This is a 5-group randomized, controlled, repeated measures trial with veterans to evaluate the relative effectiveness of three different vascularized composite allograft (VCA) donation video messaging in comparison to a general (not specific to VCA) organ donation video message and a control group without donation messaging.
Transplantation 2020P000517 Increasing VCA Donation Knowledge, Attitudes, Willingness, and Designations in Veterans: Phase III Active; Data Analysis NA
Rodrigue, James4-group randomized, controlled, repeated measures trial with veterans to evaluate whether or not including VCA messaging is more or less optimal than just general organ and tissue messaging alone. In prior phases of this research program, we surveyed veterans about their donation attitudes and conducted focus groups with veterans. The overall objective of this phase of the research is to use a mixed-methods approach to evaluate (randomized controlled trial, RCT) targeted video interventions designed to increase VCA donation knowledge, attitudes, intentions, and designations in a diverse veteran population, as well as enhance their commitment to authorize VCA donation for a deceased relative or significant other.
Transplantation 2020P001110 Increasing VCA Donation Knowledge, Attitudes, Willingness, and Designations in Veterans: Phase III Active; Not Yet Recruiting NA
Rodrigue, JamesThe purpose of this study is to evaluate the effectiveness of a targeted educational approach designed to increase knowledge about the risks and benefits of living donation generally and KPD (Kidney Paired Donation) specifically, enhance KPD self-efficacy, reduce KPD concerns, and facilitate informed decision making about KPD among incompatible or cross-match positive donor-recipient pairs.
Transplantation 2016P000409 Kidney Paired Donation: a Randomized Trial to Increase Knowledge and Informed Decision-Making Active; Data Analysis NCT03013829
Rodrigue, JamesMany living kidney donors have substantial non-reimbursed direct and indirect costs, most notably the loss of income or wages following surgery. In this NIH funded study, we will: (1) evaluate the effectiveness of offering reimbursement for living donor (LD) lost wages on the living donor kidney transplant (LDKT) rate; (2) examine whether offering reimbursement for LD lost wages reduces known racial disparities in LDKT; and (3) determine whether study outcomes differ significantly by maximum reimbursement amount for LD lost wages.
Transplantation 2017P000213 Living Donor Wage Reimbursement Trial Active; Recruiting NCT03268850
Chang, PeterTo assess the feasibility of performing a large, multicenter randomized trial evaluating the effect of home IV fluid administration after radical cystectomy.
Urology 2020P001063 Administering home intravenous fluids after radical cystectomy Pending IRB Approval NA
Olumi, AriaThe primary aim of this study is to see if the addition of prostate MRI to a panel consisting of PSA, PCA3, TMPRSS2:ERG will significantly improve specificity for high-grade prostate cancer by 10%. The subsequent exploratory aims will 1) create an optimal panel of urine, blood and tissue biomarkers that will select those cases most likely to benefit from an MRI targeted biopsy, 2) directly compare PSA and urinary biomarkers with MRI to determine which ones are value added in the setting of initial biopsy, 3) evaluate changes in these biomarkers and MRI to determine if longitudinal changes predict subsequent high-grade prostate cancer, and 4) optimize MRI imaging to improve test performance. Importantly, this study will create a unique, prospective, cohort that will become the foundational reference set for of a range of future biomarker studies.
Urology 19-334 EDRN Prostate MRI Biomarker Study And Reference Set Active; Recruiting NCT03784924
Olumi, AriaSRD5A2 is a critical enzyme for prostate development and growth, and the SRD5A2 inhibitor, finasteride, is a drug commonly used to treat benign prostatic hyperplasia (BPH). SRD5A2 is absent in 30% of normal adult men, which likely explains the resistance of a subset of patients to finasteride and other BPH therapies. This project assesses utilization of SR5A2 as a marker to identify patients who may be resistant to 5-alpha reductase inhibitor therapy for management of BPH.
Urology 2020P000202 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI therapy Active; Recruiting NCT04288427
Olumi, AriaThe purpose of this project is to create a biorepository of samples from patients who are undergoing prostate surgery at Beth Israel Deaconess Medical Center. We plan to use the tissue repository for future research to study prostate disease etiology as well as to identify genes, biomarkers, and biological processes that put patients at risk of developing prostate disease.
Urology 2019P000728 Prostate Disease Biorepository Active; Recruiting NA
Wagner, AndrewThe purpose of this study is to understand how prostate cancer behaves. One of the major goals of this research is to find unique markers associated with prostate cancer to develop better diagnostic tests and predict the outcomes of prostate cancer.
Urology 10-123 Canary Prostate Active Surveillance Study (PASS) Active; Recruiting NCT00756665
Wagner, AndrewThe goal of this study is to demonstrate the feasibility of NLM for rapid detection of prostate pathology without paraffin processing for future use in intraoperative consultation and investigate the correlation of corresponding imaging results to that of conventional histological diagnoses.
Urology 2019P000791 Evaluating Prostatectomies with Nonlinear Microscopy Active; Recruiting NA
Wagner, AndrewThe purpose of this study is to efficiently obtain accurate data to determine whether urologic surgery side effects can be measured using a web-based survey and to track the natural course of renal and adrenal masses by following select patients undergoing a period of active surveillance instead of surgery.
Urology 2009P000064 Health Related Quality of Life and Overall Patient Satisfaction with Health Care Following Urologic Surgery or Active Surveillance Active; Recruiting NA
Wagner, AndrewThe purpose of this study is to retrospectively evaluate the results, complications, and outcomes of a prospectively maintained database of patients with open and minimally invasive kidney and prostatectomy surgery.
Urology 2009P000399 Evaluation of Perioperative Results and Long-term Outcome in Patients Undergoing Kidney and Prostate Surgery Active; Data Analysis NA