Study concept and design: Samadder, Neklason, Boucher, Jones, Burt, Kuwada.
Acquisition, analysis, or interpretation of data: Samadder, Neklason, Byrne, Kanth, Samowitz, Boucher, Tavtigian, Done, Berry, Jasperson, Pappas, Smith, Sample, Davis, Topham, Lynch, Strait, McKinnon, Burt, Kuwada.
Drafting of the manuscript: Samadder, Neklason, Boucher, Pappas, Topham, Burt.
Critical revision of the manuscript for important intellectual content: Samadder, Neklason, Byrne, Kanth, Samowitz, Boucher, Jones, Tavtigian, Done, Berry, Jasperson, Smith, Sample, Davis, Lynch, Strait, McKinnon, Burt, Kuwada.
Statistical analysis: Boucher, Tavtigian, Pappas.
Obtained funding: Samadder, Jones, Tavtigian, Burt, Kuwada.
Administrative, technical, or material support: Samadder, Neklason, Byrne, Kanth, Done, Berry, Jasperson, Smith, Sample, Davis, Topham, Lynch, McKinnon, Burt, Kuwada.
Study supervision: Samadder, Neklason, Jones, Burt.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Samadder reports being a consultant for Cook Medical. Dr Jasperson reports being an employee of Ambry Genetics. Dr Burt reports being a consultant for Myriad Genetics and receiving personal fees from Thetis Pharmaceuticals. No other disclosures were reported.
Funding/Support: This project was funded by provided by grant P01-CA073992 from the National Cancer Institute (Drs Burt and Tavtigian); the Huntsman Cancer Institute Cancer Center Support Grant (NCI P30CA042014), as well as by the Huntsman Cancer Foundation; by a junior faculty career development award from the American College of Gastroenterology (Dr Samadder); and by grant 1ULTR001067 from the National Institutes of Health National Center for Advancing Translational Sciences.
Role of the Funder: The funders did not play a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Additional Contributions: We thank Tom Greene, PhD, John Fang, MD, John Valentine, MD, Curt Hagedorn, MD, Wendy Kohlmann, MS, Amanda Gammon, MS, Marjan Champine, MS, Deepika Nathan, MS, Mikaela Larson, BS, Lindsey Martineau, BS, Cristina Christenson, MPH, Megan Keener, BS, Angela Snow, MS (all at the University of Utah), for assisting with the clinical trial and patient care related to it. We also thank our external data safety monitoring board members for their assistance in the successful completion of this trial: Paul Limburg, MD (Mayo Clinic), David Weinberg, MD (Fox Chase Cancer Center), Sonia Kupfer, MD (University of Chicago), William Grady, MD (University of Washington), and Richard Holubkov, PhD (University of Utah). We thank Marc Greenblatt, MD (University of Vermont), for patient referrals into this study. We thank Ellen T. Wilson, PhD (University of Utah), for her help in editing the manuscript. Members of the external data and safety monitoring board were provided with a nominal honorarium and travel expense reimbursement for their participation in on-site safety and interim analysis meetings annually. All others received no compensation for their contributions.