Gastroenterology and Hepatology

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. Evaluation of Outcomes in Metastatic Gastric and Esophageal Carcinoma in Relation to Immunotherapy

   Rochester, Minn.

   The purpose of this study is:

   • To assess the efficacy of treatment with checkpoint inhibitors (Pembrolizumab or Nivolumab) in metastatic gastric and esophageal carcinoma through retrospective chart review.
   • To explore if response to checkpoint inhibitors is dependent on biomarkers on tumor tissue.

2. Interviews About Social Determinants of Health in Southeast Asian Americans to Identify Liver Cancer Disparities

   Rochester, Minn.

   This study is intended to understand the experiences and barriers to cancer care for individuals diagnosed with liver or any other type of cancer. Individual interviews will be conducted. 

3. Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients

   Scottsdale/Phoenix, Ariz., Rochester, Minn.

   This is a phase II multi-center study of nab-paclitaxel, gemcitabine and cisplatin (NGC triple regimen) as preoperative therapy in potentially resectable pancreatic cancer patients. DISEASE STATE - Potentially operable or borderline resectable pancreatic adenocarcinoma as assessed by standard CT criteria and histologically confirmed. - Staging by pancreatic protocol, helical abdominal computed tomography (with contrast) or MRI (with contrast) required (endoscopic ultrasound is not required). - No evidence of metastatic disease. Lymphadenopathy (defined as nodes measuring >1 cm in short axis) outside the surgical basin (i.e., para-aortic, peri-caval, celiac axis, or distant nodes) is considered M1 (unless nodes are biopsied and are negative, then enrollment can be considered after review with the study PI). Potentially Resectable Pancreatic Cancer - No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (SMA) and, if present, replaced right hepatic artery. - No involvement or <180° interface between tumor and vessel wall of the portal vein and/or superior mesenteric vein (SMV-PV) and patent portal vein/splenic vein confluence. - For tumors of the body and tail of the pancreas, involvement of the splenic artery and vein of any degree is considered resectable disease. Borderline Resectable Pancreatic Cancer - Tumor-vessel interface ≥180° of vessel wall circumference, and/or reconstructible occlusion of the SMV-PV. - Tumor-vessel interface <180° of the circumference of the SMA. - Tumor-vessel interface <180° of the circumference of the celiac artery. - Reconstructible short-segment interface of any degree between tumor and hepatic artery.

4. A Study to Understand the Mechanisms of Normal and Disordered Defection

   Rochester, Minn.

   The purpose of this study is to compare rectal emptying and rectoanal pressures in healthy people and DD. Our hypotheses are that (i) the rate and amount of rectal emptying is higher in healthy people than in patients with DD, (ii) some patients with symptoms of DD will have a normal balloon expulsion test but reduced rectal emptying measured with fecomanoflowmetry, and (iii) compared to healthy people, the rectal pressure increment and/or anal relaxation is reduced in patients with DD.
    

5. Stem Cell Coated Fistula Plug in Patients With Crohn's RVF

   Rochester, Minn.

   The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with rectovaginal fistulizing Crohn's disease. Autologous means that these cells that coat the plug come from you. You will be in this study for two years. There is potential to continue to monitor your progress with lifelong regular visits as part of your standard of care. All study visits take place at Mayo Clinic and Rochester, MN. The study visit schedule is as follows: Visit 1 (Week -6) - Screening visit: exam under anesthesia and surgery to assess eligibility of fistula tract, take fat biopsy, if eligible, and fecal diversion. Visit 2 (Week 0; Day 0), exam under anesthesia for stem cell coated fistula plug placement Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8; Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (Week 52; Month 12). Visit 10 (Week 104, Month 24)

6. A Study to Evaluate Smartphone-based Digital Phenotyping for Relapse Prediction in Alcohol-associated Liver Disease

   Rochester, Minn.

   The primary aim of this study is to define a comprehensive digital phenotype that predicts risk for near-future relapse or relapse in alcohol use in patients with alcohol-associated liver disease.

   The secondary aim of this study is to assess the relationship between this digital phenotype and markers of disease severity outcome, including MELD score and readmission rates.

7. A Study of Sonidegib and Pembrolizumab in Advanced Solid Tumors

   Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.

8. A Study to Evaluate Colorectal Polyps with Dietary Inflammation During Colonoscopy

   Jacksonville, Fla.

   Colorectal cancer is the third most commonly diagnosed cancer in both men and women in the United States (1). Colorectal cancer arises from colonic polyps. The major types of polyps associated with colorectal cancer development are adenomatous (tubular which is most common and other types are villous and tubulovillous) and serrated (hyperplastic, sessile or traditional) polyps with varying degrees of dysplasia (2). Hyperplastic polyps are common but they have a low malignancy potential (3). There is evidence that colonic inflammation plays a major role in colon polyp and colorectal cancer development. For example, inflammatory bowel disease is a major predisposing factor for colorectal cancer occurrence, implicating inflammation in the development of colorectal cancer (4). In addition,  obesity, a chronic inflammatory state, is associated with increased colorectal cancer risk (5). However, the use of anti-inflammatory agents in the prevention of colorectal cancer is controversial, although there is some suggestion that its use may lower colorectal cancer risk (6,7). Diet may affect cytokine levels and inflammation (8). Diet rich in trans-fat and sugar has been shown to increase pro-inflammatory cytokines IL-6 and TNFα (9, 10) and the Mediterranean Diet has been shown to decrease inflammatory cytokines (11) and decrease the risk of colon cancer in an UK study (12). Recently, the EDII was developed and validated to assess inflammatory potential of diet based on the Food Frequency Questionnaire (FFQ) (13).  Here we propose to investigate the association between diet-derived inflammation, as measured by the EDII, risk of colon polyps during screening colonoscopy and colorectal cancer development.

9. A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

   Rochester, Minn.

   The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

10. Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects

    Rochester, Minn.

    The purpose of this study is to assess the pharmacodynamics (PD) of HM15211 after administration of multiple subcutaneous (SC) doses compared to placebo on the liver by proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis on NASH Clinical Research Network (CRN) fibrosis score.

    Resolution of NASH is defined as non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of 0–1 for inflammation, 0 for ballooning, and any other value for steatosis