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  • Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot Scottsdale/Phoenix, Ariz.

    The purpose of this study is to to evaluate the integration of cancer genetic testing into a mammography practice aimed toward women at intermediate- to-high lifetime risk of breast cancer. If successful, this will provide an opportunity for cancer risk stratification and individualized screening.

  • EMT-FAP-001 Phase IIA Trial of Encapsulated Rapamycin (eRapa) to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance Scottsdale/Phoenix, Ariz.

    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.

     

     

  • Precision Pharmacogenomics in Cancer Patients Scottsdale/Phoenix, Ariz.

    THe purpose of this study is to examine the current and (potential) future therapeutic relevance of pharmacogenomics (PGx) testing for a cohort of cancer patients in order to improve quality of life (QOL) in patients receiving clinical care at Mayo Clinic.

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  • Gemini (Gemini) Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic Arizona cancer clinics.

  • Gemini Biorepository Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to develop a biorepository of blood samples  from cancer patients participating in the Gemini (IRB 19-006717) protocol. These samples will be used for future biomarker discovery and other translational studies. 

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  • CNTO1959COR1001:A Phase 1b, Multicenter, Randomized, Blinded, Placebo-controlled Study to Evaluate the Efficacy of Guselkumab in Subjects with Familial Adenomatous Polyposis Jacksonville, Fla., Scottsdale/Phoenix, Ariz. 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.
  • Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study (CORAL) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to to determine the sensitivity and specificity of a second-generation multi-target stool DNA test (mt-sDNA 2.0) (Cologuard 2.0®, Exact Sciences Corporation) for colorectal neoplasia (CRN) in subjects with Lynch syndrome.

     

  • ECOST = Economic and Clinical Outcomes of (whole exome) Sequencing in Tapestry (ECOST) Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The overall hypothesis is that the early detection of genetic variants leads to early interventions in cancer development.  This will lead to lower rates of cancer development and will eventually result in lower death rate from cancer.  In the short term, healthcare utilization and costs will increase due to the early interventions and treatments.  In the long term, benefit will start to emerge due to the lower disease development, lower death rate, and retaining of the quality of life and life expectancy.

  • Intercept Somatic (Intercept Somatic) Rochester, Minn. The goal of this study is to assess the diagnostic yield of concomitant germline and somatic tumor profile testing in a population of cancer patients unselected for family cancer history. In this study, we will retrospectively perform TMP on all cancer patients enrolled into the IRB 18-00326 who underwent germline genetic testing and have tumor tissue available within the Mayo Clinic Tissue Archives. TMP will be performed using a 435 gene platform, along with assessment of tumor mutational burden and microsatellite instability status, among other analyses. Paraffin-embedded tissues will be obtained from the Mayo Tissue Registry and will be shipped to Invitae (San Francisco) for the above TMP analysis. No patient identifiers will be shared with the team at Invitae. Somatic mutation analysis by next-generation sequencing (NGS) is an expanding clinical assessment being offered to cancer patients and we hypothesize will have implications for the patient’s acute treatment, ongoing surveillance, and the screening of family members.
  • Mayo Clinic Arizona Inherited Cancer Clinic Biorepository Scottsdale/Phoenix, Ariz.

    The purpose of this study is to create a database of clinical information and a repository of biological specimens for genetic, molecular and microbiological research to better understand hereditary cancer and help develop new therapies and preventive strategies.

  • Mayo Clinic Cancer Genomics Service Line Biorepository Rochester, Minn., Eau Claire, Wis., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

    The goal of the study is to create a database of clinical information and a repository of biological specimens for genetic, molecular and microbiological research to better understand hereditary cancer and help develop new therapies and preventive strategies.

  • 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. 

     

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