TY - JOUR
T1 - Definitive characterization of CA 19-9 in resectable pancreatic cancer using a reference set of serum and plasma specimens
AU - Haab, Brian B.
AU - Huang, Ying
AU - Balasenthil, Seetharaman
AU - Partyka, Katie
AU - Tang, Huiyuan
AU - Anderson, Michelle
AU - Allen, Peter
AU - Sasson, Aaron
AU - Zeh, Herbert
AU - Kaul, Karen
AU - Kletter, Doron
AU - Ge, Shaokui
AU - Bern, Marshall
AU - Kwon, Richard
AU - Blasutig, Ivan
AU - Srivastava, Sudhir
AU - Frazier, Marsha L.
AU - Sen, Subrata
AU - Hollingsworth, Michael A.
AU - Rinaudo, Jo Ann
AU - Killary, Ann M.
AU - Brand, Randall E.
PY - 2015/10/2
Y1 - 2015/10/2
N2 - The validation of candidate biomarkers often is hampered by the lack of a reliable means of assessing and comparing performance. We present here a reference set of serum and plasma samples to facilitate the validation of biomarkers for resectable pancreatic cancer. The reference set includes a large cohort of stage I-II pancreatic cancer patients, recruited from 5 different institutions, and relevant control groups. We characterized the performance of the current best serological biomarker for pancreatic cancer, CA 19-9, using plasma samples from the reference set to provide a benchmark for future biomarker studies and to further our knowledge of CA 19-9 in early-stage pancreatic cancer and the control groups. CA 19-9 distinguished pancreatic cancers from the healthy and chronic pancreatitis groups with an average sensitivity and specificity of 70-74%, similar to previous studies using all stages of pancreatic cancer. Chronic pancreatitis patients did not show CA 19-9 elevations, but patients with benign biliary obstruction had elevations nearly as high as the cancer patients. We gained additional information about the biomarker by comparing two distinct assays. The two CA 9-9 assays agreed well in overall performance but diverged in measurements of individual samples, potentially due to subtle differences in antibody specificity as revealed by glycan array analysis. Thus, the reference set promises be a valuable resource for biomarker validation and comparison, and the CA 19-9 data presented here will be useful for benchmarking and for exploring relationships to CA 19-9.
AB - The validation of candidate biomarkers often is hampered by the lack of a reliable means of assessing and comparing performance. We present here a reference set of serum and plasma samples to facilitate the validation of biomarkers for resectable pancreatic cancer. The reference set includes a large cohort of stage I-II pancreatic cancer patients, recruited from 5 different institutions, and relevant control groups. We characterized the performance of the current best serological biomarker for pancreatic cancer, CA 19-9, using plasma samples from the reference set to provide a benchmark for future biomarker studies and to further our knowledge of CA 19-9 in early-stage pancreatic cancer and the control groups. CA 19-9 distinguished pancreatic cancers from the healthy and chronic pancreatitis groups with an average sensitivity and specificity of 70-74%, similar to previous studies using all stages of pancreatic cancer. Chronic pancreatitis patients did not show CA 19-9 elevations, but patients with benign biliary obstruction had elevations nearly as high as the cancer patients. We gained additional information about the biomarker by comparing two distinct assays. The two CA 9-9 assays agreed well in overall performance but diverged in measurements of individual samples, potentially due to subtle differences in antibody specificity as revealed by glycan array analysis. Thus, the reference set promises be a valuable resource for biomarker validation and comparison, and the CA 19-9 data presented here will be useful for benchmarking and for exploring relationships to CA 19-9.
UR - https://www.scopus.com/pages/publications/84947294520
U2 - 10.1371/journal.pone.0139049
DO - 10.1371/journal.pone.0139049
M3 - Article
C2 - 26431551
SN - 1932-6203
VL - 10
JO - PLoS ONE
JF - PLoS ONE
IS - 10
M1 - e0139049
ER -