Gastroenterology and Hepatology

Below are current clinical trials.

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

1. Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.

2. Study of CX-4945 in Combination With Gemcitabine and Cisplatin for Frontline Treatment of Cholangiocarcinoma

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

   This study considers the safety and tolerability of increasing doses of CX-4945 in combination with gemcitabine plus cisplatin to determine the maximum tolerated dose (MTD), followed by a randomized study that compares antitumor activity in cholangiocarcinoma patients receiving the standard of care gemcitabine plus cisplatin versus CX-4945 at the combination MTD with gemcitabine plus cisplatin.

3. A Study to Determine the Microbial Population of the Intestines in Patients with Active or Treated Inactive Eosinophilic Esophagitis

   Rochester, Minn.

   The purpose of this study is to collect stool samples and determine the intestine microbe environment in patients who have active or treated inactive eosinophilic esophagitis.

4. Characterization of the Neo-squamous Epithelial Barrier

   Rochester, Minn.

   To prospectively assess the functional aspects of the the esophageal squamous epithelial barrier and correlate this with tissue inflammation and intercellular space dilation in patients who have successfully completed endoscopic therapy for Barrett's Esophagus related metaplasia.

5. A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

   Rochester, Minn.

   This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.

6. Role of Intestinal Inflammation in the Pathogenesis of Type 1 Diabetes

   Rochester, Minn.

   This purpose of this study is to determine if activation of a person's immune system in the small intestine could be a contributing cause of Type 1 Diabetes.

7. A Study to Assess DNA Tumor Markers in Whole Blood Specimens of Patients with Newly Diagnosed Lung Cancer

   Rochester, Minn.

   The purpose of this study is to assess Methylated DNA tumor markers distributed in blood samples of patients newly diagnosed with different types of lung cancer. The goal is to develop new blood screening tests that can identify the type and primary site of cancer.

8. Phase 4 Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis

   Rochester, Minn.

   The purpose of this study is to assess the efficacy and safety of vedolizumab intravenous (IV) in participants with a proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis (UC) who have developed chronic or recurrent pouchitis, or require continuous antibiotic treatment.

9. Phase 1 Crohn's Pediatric Sub-study of MSC AFP

   Rochester, Minn.

   The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore Bio-A Fistula Plug) in a Phase I study using a single dose of 20 million cells. 20 patients (age 12 to 17 years) with Crohns perianal fistulas will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient.

10. A Study to Determine if Differences in the Microbe Environment of the Intestines Connects to the Effects of Obesity on Intestinal Stem Cells

    Rochester, Minn.

    New studies are revealing how a high-fat diet could be making the cells of the intestinal lining more likely to become cancerous. The purpose of this study is to find how the microbe envntironment of the intestines in obesity influences the growth of intestinal stem cells, which could then trigger intestinal tumors.