Ethics approval and consent to participate: The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board of Sanford Research (protocol code 03-11-028 and date of approval March 24th, 2011). Informed consent was obtained from all subjects involved in the study.
Consent for publication: Applicable, obtained through informed consent.
Availability of data and materials: The data presented in this study are available on request from the corresponding author. The data are not publicly available due to patient privacy.
Competing Interests: Steven Powell has received research grant support to the institution from Merck, Bristol Myers Squib, Pfizer, Vyriad, Incyte, Actuate, Genentech, Seattle Genetics anded consulting support to the institution from Bristol Myers Squibb. William Spanos received consulting support for Bristol Myers Squibb, Regeneron, and Merck. The other authors declare no competing interests.
Funding: Translational metabolite analysis was supported by Center of Biology Research Excellence Award No. 5P20-GM103548-09, sponsored by the National Institute of General Medical Science. Funding for the clinical trial was provided by Sanford Research.
Authors’ Contributions: S.C.M., M.M.L., S.E.P., W.K.M, J.H.L., W.C.S. contributed to conception and design; Material preparation, data collection and analysis were performed by S.F.P., M.M., E.G.D., J.S.B., L.H.G., M.T., M.M.L., S.C.M., A.W.J., C.A.E., V.J.R. J.H.L., W.C.S.; The first draft of the manuscript was written by S.F.P., C.A.E., V.J.R, S.E.P., J.H.L., W.C.S and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
Acknowledgements: The authors would like to acknowledge the patients and families who participated in this research. Additionally, they would like to acknowledge the Sanford Research Clinical Research Coordinators, Histology and Imaging Core, and Research Design and Biostatistics Core.
Author information:
Sanford Cancer Center, 1309 W. 17th Street, Suite 101, Sioux Falls, SD, 57104, USA – Steven F. Powell, Miroslaw Mazurczak, Jonathon S. Bleeker, Michele Lohr, Steven McGraw, William C. Spanos
Sanford Roger Maris Cancer Center, 820 4th St N, Fargo, ND, 58102, USA - Louis H. Geeraerts, Matthew Tinguely, Ashley W. Jensen
Sanford Research, 301 East 60th St N, Sioux Falls, SD, 57104, USA - Steven F. Powell, Miroslaw Mazurczak, Jonathon S. Bleeker, Christie A. Ellison, Lora J. Black, Valerie J. Reed, W. Keith Miskimins, William C. Spanos
University of South Dakota Sanford School of Medicine, 414 E. Clark St., Vermillion, SD, 57069, USA - Steven Powell, Miroslaw Mazurczak, Jonathon Bleeker, Michele Lohr, Steven McGraw, William Spanos
St. Joseph Mercy Cancer Center, 5301 Elliott Dr. Ste 210 Ypsilanti, MI 48197, USA – Elie G. Dib
University of South Dakota School of Health Sciences, 414 E. Clark St., Vermillion, SD, 57069, USA - Susan E. Puumala
Avera Cancer Institute, 1000 E 23rd St, Sioux Falls, SD 57105, USA – John H. Lee
Corresponding Author: Steven F. Powell, Email: [email protected] ; ORCID: 0000-0002-5029-0048
Compliance with Ethical Standards
Disclosure of potential conflicts of interest: Steven Powell has received research grant support to the institution from Merck, Bristol Myers Squib, Pfizer, Vyriad, Incyte, Actuate, Genentech, Seattle Genetics anded consulting support to the institution from Bristol Myers Squibb. William Spanos received consulting support for Bristol Myers Squibb, Regeneron, and Merck. The other authors declare no conflict of interest.
Research involving Human Participants and/or Animals: The study involved human participants and was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Institutional Review Board of Sanford Research (protocol code 03-11-028 and date of approval March 24th, 2011).
Informed consent: Written informed consent was obtained from all subjects involved in the study.