Clinical Trials

The overarching goal of this study is to develop a comprehensive translational research platform that utilizes blood, stool, and tissues from colorectal cancer patients to evaluate the impact of tumor/immune microenvironment and genetic alterations on clinical outcomes to anticancer therapy and vice versa. The specific aims are to establish co-cultures of patient-derived tumor cells with autologous or allogeneic immune cells to analyze how anticancer therapy modulate the composition and potential of immune cells, to establish patient-derived xenographs and organoids to improve dosing of chemotherapy, and to perform molecular analysis with biospecimens to identify novel therapeutic sequence, targets, and predictive or prognostic biomarkers.

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.

The purpose of this study is to evaluate the short-term outcomes and the quality of life (QOL) after cholecystectomy and hepatic artery infusion pump placement for localized unresectable colorectal liver metastases (CRLM).

The purpose of applying to the Institutional Review Board (IRB) for the collection of GI-related tissue is to enable comprehensive molecular investigations into the mechanisms underlying gastrointestinal cancers and diseases.

The purpose of this study is to collect blood and stool samples to validate and improve the performance of stool and blood DNA markers for inflammatory bowel disease and colorectal neoplasia critical to the long-term goal of improving effectiveness of neoplasia detection in patients using non-invasive biomarkers to assist colonoscopy and radiographic screening. 

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 sequence patient germline and tumor samples, and nominate top neoantigen candidates using an in-house developed bioinformatics pipeline, and to validate the neoantigen candidates by laboratory assays using patient peripheral blood immune cells or serum.

The primary objectives for this study are: 

• The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 6 months of documentation of HLA-A LOH status
• The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 12 months of documentation of HLA-A LOH status
• The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 18 months of documentation of HLA-A LOH status
• The percentage of subjects who can enroll on an A2 CAR T-cell therapy study within approximately 24 months of HLA-A LOH status
• Percentage of screened subjects experiencing loss of heterozygosity of HLA-A*02.

The purpose of this multicenter prospective observational case-control study is to train and validate Adela’s cfMeDIP-seq based methylome profiling platform to detect and differentiate multiple cancer subtypes. In addition, this study includes longitudinal follow-up for a subset of participants to train and validate the methylome profiling platform to detect minimal residual disease and recurrence.

The purpose of this study is to collect blood and tissue samples from patients with and without cancer to evaluate laboratory tests for early cancer detection which may help researchers develop tests for the early detection of cancers.