Cancer

Below are current clinical trials.

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1. 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.

2. Human Blood and Tissues Repository for Neuroscience Research

   Jacksonville, Fla.

   The purpose of this study is to collect adult human blood, cerebrospinal fluid, brain, and spine tissues/fluids at time of surgery in order to conduct future studies of the cellular mechanisms of tissue invasion utilized by brain and spine tumors of the central nervous system (CNS).

3. A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC

   Rochester, Minn.

   This is a Phase I/II study designed to evaluate if experimental anti-TIGIT/anti-PD-1 bispecific antibody rilvegostomig (AZD2936) is safe, tolerable and efficacious in participants with Advanced or Metastatic Non-small Cell Lung Cancer.

4. MC230818 Understanding the mechanisms of clonal and non-clonal cytopenia following CAR-T therapy (MC230818)

   Mankato, Minn., Rochester, Minn., La Crosse, Wis., Jacksonville, Fla., Eau Claire, Wis., Scottsdale/Phoenix, Ariz., Albert Lea, Minn.

   Determine the preexisting and therapy-emergent germline and somatic variants associated with an increased risk of clonal and non-clonal cytopenia following CAR-T cell therapy.

5. A Study Evaluating The Safety, Efficacy, And Pharmacokinetics Of Mosunetuzumab And A Combined Regimen Of Mosunetuzumab And Venetoclax In Participants With Relapsed Or Refractory Chronic Lymphocytic Leukemia

   Rochester, Minn.

   This study will assess the safety, tolerability, pharmaokinetics, and preliminary efficacy of mosunetuzumab (Lunsumio) monotherapy in participants with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). This study will also allow participants who are currently progressing on a Bruton tyrosine kinase inhibitor (BTKi) and requiring salvage therapy as assessed by the treating physician to continue their BTKi throughout the screening period and for the first two cycles of mosunetuzumab. An additional arm (open to non-US participants only) has been added to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with venetoclax, a B-cell lymphoma 2 (BCL2) inhibitor.

6. A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma

   Rochester, Minn.

   The purpose of this study is to define the recommended dose, safety, tolerability, immunogenicity, and preliminary effectiveness of EO2463 during monotherapy and in combination with lenalidomide and/or rituximab in patients with indolent Non-Hodgkin's Lymphoma (NHL).

7. Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma

   Rochester, Minn.

   The purpose of this study is to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma.

   Additionally, to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.

8. ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation (ORACLE)

   Rochester, Minn.

   The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.

9. MC1733, Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter pylori Neutrophil-activating Protein (NAP) (MV-s-NAP) in Patients with Metastatic Breast Cancer

   Rochester, Minn.

   To determine the maximally tolerated dose (MTD) of intratumoral administration of an Edmonston strain measeles virus genetically engineered to express NAP (MV-s-NAP) in patients with metastatic breast cancer; to determine the safety and toxicity of on-time and serial administration of MV-s-NAP in patients with metastic breast cancer. 

10. Bladder Bank (a Prospective Banking Study)

    Rochester, Minn.

    The purpose of this study is to establish samples (blood and urine) to support the development of non-invasive tests for early detection of bladder cancer