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Clinical Studies

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  • CPN1128 “Plasma and sputum microRNAs: utility as noninvasive biomarkers for the progression/regression of bronchial dysplasia” Rochester, Minn. This study is designed to determine whether or not plasma and sputum microRNA might be an effective, non-invasive biomarker for lung cancer risk.
  • CPN1741 T-Cell Receptor Repertoire (TCR) Repertoire Pre- and Post-MUC1 Vaccine Rochester, Minn. Can T cell receptor repertoires serve as a biomarker of T cell response to a MUC1 vaccine?
  • CPN1742 Differential Gene Expression Signature as a Predictive Biomarker of an Immune Response to a Preventative Cancer Vaccine Rochester, Minn. Can the genetic makeup of an individual who does not yet have cancer provide an indication of the risk of future cancer?
  • CPN1941 “Single cell RNAseq analysis of PBMCs of responders versus non-responders to the MUC1 vaccine” (MUC1 responders RNAseq) Rochester, Minn.

    A preventative MUC1 vaccine being tested in a clinical trial MAY13-01-01 in individuals with a history of advanced adenomas and an increased risk for colon cancer, gives 2 different outcomes.  About half of vaccinated individuals make a strong anti-MUC1 IgG (vaccine responders) and the other half do not (vaccine non-responders).  We have been analyzing differential gene expression in pre-vaccination PBMCs from these two groups to identify a gene expression signature that can predict response. We are now proposing to confirm and extend these studies by doing gene expression analysis at the single cell level rather than total PBMC.  This will allow us to better understand the gene expression differences we have already identified by total PBMC RNAseq and to determine if differences we see exist across the board in many cell populations in the PBMC or are limited to just a few cell population(s) that are for some reason expended in one group and not in the other. Since the ultimate goal of acquiring this knowledge is to identify various targets for therapy that would turn everyone into a vaccine responder, the ability to properly interpret the gene expression differences will be very important. Our hypothesis is that a single cell RNAseq analysis of PBMC from 8 responders and 8 non-responders to the MUC1 vaccine, which were already analyzed by RNAseq of total PBMC, will distinguish between the across the board differences in gene expression versus differences in specific (new) cell populations between these two groups. Our Specific Aim is to select frozen PBMC from 8 responders (positive in ELISA for anti-MUC1 IgG at week 12 post-vaccination) and 8 non-responders (negative for anti-MUC1 IgG) and put them through single cell RNA sequencing as described below.  Multiple analyses will be performed on the resulting sequences, including specific cell population composition as well as differences in gene expression between these cell populations

  • CPN1942 The GUCY2C-cyclic GMP Pharmacodynamic Axis in Organoids from Rectal Mucosa Rochester, Minn.

    The purpose of this study is to explore the level of similarity in pharmacodynamic responses to GUCY2C agonists in organoids prepared from rectal biopsies from all healthy subjects, independent of changes in their bowel movements induced by oral administration of 27 mg/day of dolcanatide for 7 days.



  • Phase I, Randomized, Placebo-Controlled Trial of Linaclotide to Demonstrate Colorectal Bioactivity in Healthy Volunteers Rochester, Minn.

    This randomized phase I trial studies the side effects and best dose of linaclotide acetate in preventing colorectal cancer in healthy volunteers. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of linaclotide acetate may prevent colorectal cancer.

  • Phase II Trial of Weekly Erlotinib Dosing to Reduce Duodenal Polyp Burden Associated With Familial Adenomatous Polyposis Rochester, Minn., Scottsdale/Phoenix, Ariz.

    This phase II trial studies the side effects of erlotinib hydrochloride and how well it works in reducing duodenal polyp burden in patients with familial adenomatous polyposis at risk of developing colon cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

  • Review of Post-Study Clinical Endoscopy Records in Follow Up to MAY2016-07-01 Weekly Erlotinib for Familial Adenomatous Polyposis (MAY2016-07-01F) Scottsdale/Phoenix, Ariz., Rochester, Minn.

    The purpose of this study is to review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, MAY2016-07-01, who provide consent for the review of their medical records.  There have been reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol.  A review of literature found insufficient data to determine whether or not there is a longer term safety risk to the participant in MAY2016-07-01.