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A Study to Review the Safety of Familial Adenomatous Polyposis/Erlotinib Study
Scottsdale/Phoenix, AZ
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.
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A Study to Evaluate Encapsulated Rapamycin to Prevent Progression of Familial Adenomatous Polyposis in Patients
Scottsdale/Phoenix, AZ
The purposes of this study are to analyze the frequency and severity of adverse events associated with low-dose encapsulated rapamycin in Familial Adenomatous Polyposis (FAP), to determine the recommended phase 2 dose (RP2D) based on assessment of safety, long-term tolerability, optimal blood levels, and clinical benefit, and to determine the effectiveness of eRapa in delaying polyp progression in patients with FAP compared to historic controls.
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Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer
Scottsdale/Phoenix, AZ
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.
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A Database to Monitor Outcomes and Function Following Ileal Pouch Anal Anastomosis
Rochester, MN
The purpose of this study is to analyze patient outcomes after ileal pouch anal anastomosis.
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Return of Actionable Variants Empirical
Rochester, MN
The purpose of this study is to conduct a genomic medicine implementation project to establish mechanisms for return of actionable findings from targeted sequencing of ~109 disease-relevant genes and genotyping of select polymorphisms in a large study setting (eMERGE III consortium). A primary focus of the Mayo group will be on two common actionable genetic disorders–familial hyperlipidemia (FH) and familial colorectal cancer (CRC).
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A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis
Scottsdale/Phoenix, AZ; Jacksonville, FL
This is a proof-of-concept study to evaluate the preliminary clinical activity of guselkumab in subjects with Familial Adenomatous Polyposis. The study is designed to determine if guselkumab has clinical activity in the colorectum and duodenum, by reducing the number of polyps over a period of 24 weeks.
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Trial of Eflornithine Plus Sulindac in Patients with Familial Adenomatous Polyposis (FAP)
Rochester, MN
The purpose of this randomized, double-blind, Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of any FAP-related event. This includes: 1) FAP related disease progression indicating the need for excisional intervention involving the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes progression to more advanced duodenal polyposis, cancer or death.