Author Contributions: Dr Waldman had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Waldman, Hyslop, Weinberg.
Acquisition of data: Waldman, Hyslop, Schulz, Barkun, Nielsen, Haaf, Bonaccorso, Li, Weinberg.
Analysis and interpretation of data: Waldman, Hyslop, Schulz, Barkun, Li, Weinberg.
Drafting of the manuscript: Waldman, Hyslop, Schulz, Barkun, Li, Weinberg.
Critical revision of the manuscript for important intellectual content: Waldman, Hyslop, Barkun, Weinberg.
Statistical analysis: Hyslop, Li.
Obtained funding: Waldman, Hyslop, Weinberg.
Administrative, technical, or material support: Waldman, Barkun, Nielsen, Haaf, Bonaccorso, Weinberg.
Study supervision: Waldman, Hyslop, Schulz, Weinberg.
Financial Disclosures: Dr Waldman reported being a paid consultant to Merck, and the chair (uncompensated) of the Scientific Advisory Board of Targeted Diagnostics and Therapeutics, Inc, which provided research funding that, in part, supported this study and which has a license to commercialize inventions related to this work. Dr Weinberg reported being a shareholder in Targeted Diagnostics and Therapeutics, Inc. No other authors reported financial discosures.
Funding/Support: This study was supported by National Institutes of Health grants CA75123 and CA95026 (to Dr Waldman) and CA112147 (to Dr Hyslop) and by funding from the Targeted Diagnostic and Therapeutics Inc (to Dr Waldman). Dr Waldman is the Samuel M. V. Hamilton Endowed Professor of Thomas Jefferson University.
Role of the Sponsor: The sponsors had no role in the design and conduct of the study; in the collection, management, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
Participating Groups:Thomas Jefferson Hospital (coordinating center), Thomas Jefferson University, Philadelphia, Pennsylvania (Scott A. Waldman, MD, PhD, project primary investigator; Stephanie Schulz, PhD, analytical primary investigator; Terry Hyslop, PhD, statistical primary investigator; Janis Haaf, RN, and Christine Bonaccorso, RN, project coordinators; Karl Nielsen, BS, analytical coordinator; Juan Palazzo, MD, pathologist; Kathleen Ackerman, pathology assistant; and Robert Fry, MD, Pauline Park, MD, Scott Goldstein, MD, and Gerald Isenberg, MD, surgeons). Montreal General Hospital, Royal Victoria Hospital, Montreal Jewish Hospital (study sites), McGill University, Montreal, Quebec, Canada (Alan Barkun, MD, site primary investigator; Victoria Marcus, MD, Leslie Alpert, MD, and Esther Lamoureux, MD, pathologists; Gabriel Gabriel and Ehab Yaney, pathology assistants; and Vicky Thiffault, Laura Kor, Kellee Durnin, and Joyce Strazzulla, clinical coordinators). Virtua Health System, Voorhees and Mt Holly, New Jersey (study sites): (Stephen Pilipshen, MD, site primary investigator; William Cody, MD, David Schaffzin, MD, and Gary Siemons, MD, surgeons; Sergiy Koval, ASCP, pathology assistant; and Judy Neuman, Teri Grand, Patricia Harris, Joyce Guy, and Raina Moyer, clinical coordinators). University Hospital, Gainesville VA Medical Center (study site), University of Florida, Gainesville (Rodwige J. Desnoyers, MD, site primary investigator; Scott Schell, MD, PhD, surgeon; James Crawford, MD, PhD, pathology; and Valerie Paget-Wilkes, RN, clinical coordinator). Fox Chase Cancer Center, Philadelphia, Pennsylvania (study site): (David Weinberg, MD, site primary investigator and project coinvestigator; Harry Cooper, MD, pathologist; Elin Sigurdson, MD, Natalie Joseph, MD, and James Watson, MD, surgeons; Paul Engstrom, MD, medical oncologist; and Eileen Keenan, clinical coordinator).
Data and Safety Monitoring Committee: Departments of Medicine (Bruce Boman), Medical Oncology (Neal Flomenberg, MD, PhD), and Radiation Oncology (Walter Curran, MD), Thomas Jefferson University, Philadelphia, Pennsylvania.