Clinical Trials

The characteristics and role of gut microbiome rare plasma cell disorders- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) and amyloid light-chain (AL) amyloidosis, have not been explored; and their pathophysiology is quite elusive. To help understand rare plasma cell disorders and its association with gut microbiome, we will study the stool samples of newly diagnosed POEMS patients and AL amyloidosis and compare it with patients with newly diagnosed monoclonal gammopathy of undetermined significance and multiple myeloma as well as healthy controls. Moreover, gut microbiome in newly diagnosed POEMS patients will be compared to POEMS patients in remission. It is our overall hypothesis that in POEMS patients the gut microbiome signature will differ between active disease (at diagnosis) and inactive disease (in remission), and the gut microbiome in POEMS patients will be different from patients with other plasma cell disorders and healthy controls

The purpose of this study is to collect adiopose tissue to derive mesenchymal stem cells.

The purpose of this study is to search for necessary changes in programming or assessment structure in order to reliably capture behavioral assessments from patients during their stay in the epilepsy monitoring unit. Behavioral assessments will be collected during period of time without seizure activity, during seizure activity, and immediately after a seizure event.

The purpose of this study is to develop tools to better predict which patients will be at highest risk of lung complications following bone marrow transplantation.

Medical education and continuous professional development (CPD) are effective when it demonstrates translation of learning to clinical practice. The severe acute respiratory syndrome coronavirus 2 (COVID-19) pandemic has changed the landscape of CPD as in-person meetings and the associated social networking that occurs through these interactions has now largely disappeared. Limited data exists to guide the integration of social learning into online education; this study seeks to increase understanding of the impact of social learning on online education. The theory of planned behavior (TPB) will be used as a framework to evaluate impact.

• AIM 1: Identify differences in knowledge acquisition, attitudes, values, beliefs, and intent to utilize pharmacogenomics (PGx) in clinical practice between two groups: one who has participated in an online PGx education program only and one who has participated in an online PGx education program and participated in small group discussion about the content led by a subject matter expert (PGx pharmacist). Small group discussion allows for learning from both experts and peers in a collective group that supports social interaction. It is hypothesized that those who participate in the small group discussion will score more positively in relation to knowledge, attitudes, values, and beliefs than those who participate in the online education only.
•  AIM 2: Gain a deeper understanding of the practice impact of incorporating social learning theory constructs into online CPD education. This will be assessed by measuring the number of PGx tests and consults ordered after the CPD education. Further, a survey will measure self-reported use of PGx in making care decisions. It is hypothesized that those who participate in the small group discussion will be more likely to use PGx principles in the clinical environment and incorporate PGx information as a part of regular clinical practice. To achieve these aims, a randomized prospective study of physicians, nurse practitioners, and physician assistants who practice at throughout the Mayo Clinic enterprise will be conducted. Data from this study will help identify the impact of social learning theory on supporting implementation of PGx learning into practice and guide future endeavors.

The natural course of autosomal dominant polycystic kidney disease (ADPKD) is highly variable and typically characterized by progressive enlargement of cysts within the kidneys.  ADPKD is a leading cause of end-stage renal disease.  Recently, a new medication called Tolvaptan has been approved by the FDA to slow progression of ADPKD.  Accurate, MR based kidney volume measurements are the best parameter for following the progression of ADPKD, and are suggested be acquired to measure progression and effects of Tolvaptan.  However, making these slice-by-slice volume measurements can be extremely time consuming when done manually.  The purpose of this work is to evaluate an AI algorithm to make the measurements.  The results of the algorithm will be reviewed by a qualified radiologist familiar with the algorithm’s results.  If the radiologist agrees with the results, kidney volumes (left, right and combined) will be recorded for clinical use.  The usage of the algorithm in this setting (with review by radiologist, and manual correction) is a minimal risk to the patients: a failure of the algorithm will have no impact on treatment and errors will be caught and corrected by the QC process. Because the algorithm will not be used solely for diagnosis or inform treatment without the confirmation of the diagnosis by another, medically established diagnostic product or procedure this study constitutes minimal risk to patients. 

This study is designed to investigate both the quality of life of facial deformity patients, their attitudes towards facial transplantation, as well as the barriers that prevent such patients from seeking face transplants.

This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic Pancreatic SPORE, “Optimal Immunotargeting of MUC1 for Advanced Pancreatic Cancer” (Principal Investigator Dr. Gendler). Eligibility Criteria, keep current Eligibility Criteria, but precede by:: "Three cohorts of patients will be collected.:Cohort 1 includes (1) advanced unresectable pancreatic cancer, (2-4) advanced, unresectable breast cancer (up to 6 donors per phenotype: triple negative [HER2, estrogen and progesterone receptor (ER and PR) all negative], HER2 positive whatever the ER/PR status,, and HER2 negative/ER positive), (5) advanced, unresectable colorectal cancer, (6) advanced, unresectable ovarian cancer, (7) advanced, unresectable clear cell kidney cancer, (8) advanced, unresectable bladder cancer, (9) advanced, unresectable lung adenocarcinoma, (10) advanced, unresectable multiple myeloma. Also eligible are (11) up to 6 donors with triple negative breast cancer and (12) up to 6 donors with colorectal cancer who have no clinical evidence of residual (macroscopic) disease following an attempt to perform definitive treatment (including surgery, radiation and/or adjuvant or neoadjuvant chemotherapy). Cohort 2 includes (1) muCALR+ primary MF, and (2) muCALR+ secondary MF. Cohort 3 includes (1) CMVpp65 absent and (2) CMVpp65 present GBM.. Patients in all subcohorts except 1.11 and 1.12 currently have unresectable advanced or recurrent cancers, and may undergo the collection: (1) prior to initiation of systemic therapy; (2) if patient is already engaged in an ongoing cyclical systemic therapy, collection should be within three days prior to the end of the current therapy cycle, if necessary delayed until all clinical parameters are acceptable to proceed with the next planned cycle of therapy; (3) if patient is completing non-cyclical therapy, collection should be at least 2.5-3.0 weeks after completion of the therapy, or delayed until all clinical parameters are acceptable to proceed with any planned follow-up therapy. Patients in cohorts 1.11 and 1.12 (currently lacking detectable cancer) will undergo the collection at least 4 weeks after conclusion of therapy. In addition to belonging to one of these 16 subcohorts, patients will be required to have bloodwork demonstrating a blood hemoglobin ≥ 10 g/dL, a neutrophil count ≥ 1,500 /microliter, and platelets ≥ 100,000 /microliter, performed within 7 days prior to the collection.

The purpose of this study is to determine the proper criteria for diagnosis of IgG4-related disease (IgG4-RD), identify strategies to avoid relapse and identify specific factors that underlie IgG4-RD disease pathophysiology.

The purpose of this study is to establish an opioid and multiple addiction (OMA) biobank that creates a comprehensive standard patient phenotype using standardized subjective assessments and objective behavioral measurements for future research.