title: Pancreatic cancer serum biomarker PC-594: Diagnostic performance and comparison to CA19-9.
abstract: OBJECTIVE
  To investigate serum PC-594 fatty acid levels as a potential biomarker in North American pancreatic cancer (PaC) patients, and to compare its performance to CA19-9.
  
  
  METHODS
  Using tandem mass spectrometry, we evaluated serum PC-594 levels from 84 North American patients with confirmed PaC and 99 cancer-free control subjects. We determined CA19-9 levels by ELISA. Significance between PaC patients and controls, and association with clinical variables was determined by analysis of variance and t-tests. Diagnostic performance was evaluated by receiver-operator characteristic (ROC) curve analysis, and PC-594 correlation with age and CA19-9 determined by regression analysis.
  
  
  RESULTS
  Mean PC-594 levels were 3.7 times lower in PaC patients compared to controls (P < 0.0001). The mean level in PaC patient serum was 0.76 ± 0.07 μmol/L, and the mean level in control subjects was 2.79 ± 0.15 μmol/L. There was no correlation between PC-594 and age, disease stage or gender (P > 0.05). Using 1.25 μmol/L as a PC-594 threshold produced a relative risk (RR) of 9.4 (P < 0.0001, 95%CI: 5.0-17.7). The area under the receiver-operator characteristic curve (ROC-AUC) was 0.93 (95%CI: 0.91-0.95) for PC-594 and 0.85 (95%CI: 0.82-0.88) for CA19-9. Sensitivity at 90% specificity was 87% for PC-594 and 71% for CA19-9. Six PaC patients with CA19-9 above 35 U/mL showed normal PC-594 levels, while 24 PaC patients with normal CA19-9 showed low PC-594 levels. Eighty-five of the 99 control subjects (86%) showed normal levels of both markers.
  
  
  CONCLUSIONS
  PC-594 biomarker levels are significantly reduced in North American PaC patients, and showed superior diagnostic performance compared to CA19-9.
authors.affiliation: Shawn A Ritchie, Bassirou Chitou, Dushmanthi Jayasinghe, Department of Biomarker Discovery and Validation, Phenomenome Discoveries, Saskatoon, SK S7N 4L8, Canada.
authors.forename: Shawn A
authors.initials: SA
authors.lastname: Ritchie
authors.affiliation: Shawn A Ritchie, Bassirou Chitou, Dushmanthi Jayasinghe, Department of Biomarker Discovery and Validation, Phenomenome Discoveries, Saskatoon, SK S7N 4L8, Canada.
authors.forename: Bassirou
authors.initials: B
authors.lastname: Chitou
authors.affiliation: Shawn A Ritchie, Bassirou Chitou, Dushmanthi Jayasinghe, Department of Biomarker Discovery and Validation, Phenomenome Discoveries, Saskatoon, SK S7N 4L8, Canada.
authors.forename: Qingan
authors.initials: Q
authors.lastname: Zheng
authors.affiliation: Shawn A Ritchie, Bassirou Chitou, Dushmanthi Jayasinghe, Department of Biomarker Discovery and Validation, Phenomenome Discoveries, Saskatoon, SK S7N 4L8, Canada.
authors.forename: Dushmanthi
authors.initials: D
authors.lastname: Jayasinghe
authors.affiliation: Shawn A Ritchie, Bassirou Chitou, Dushmanthi Jayasinghe, Department of Biomarker Discovery and Validation, Phenomenome Discoveries, Saskatoon, SK S7N 4L8, Canada.
authors.forename: Wei
authors.initials: W
authors.lastname: Jin
authors.affiliation: Shawn A Ritchie, Bassirou Chitou, Dushmanthi Jayasinghe, Department of Biomarker Discovery and Validation, Phenomenome Discoveries, Saskatoon, SK S7N 4L8, Canada.
authors.forename: Asuka
authors.initials: A
authors.lastname: Mochizuki
authors.affiliation: Shawn A Ritchie, Bassirou Chitou, Dushmanthi Jayasinghe, Department of Biomarker Discovery and Validation, Phenomenome Discoveries, Saskatoon, SK S7N 4L8, Canada.
authors.forename: Dayan B
authors.initials: DB
authors.lastname: Goodenowe
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019540:Area Under Curve; D018395:CA-19-9 Antigen / Q000097:blood*; D015536:Down-Regulation; D004797:Enzyme-Linked Immunosorbent Assay; D005231:Fatty Acids, Unsaturated / Q000097:blood*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009656:North America / Q000453:epidemiology; D010190:Pancreatic Neoplasms / Q000097:blood* / Q000453:epidemiology; D011237:Predictive Value of Tests; D012372:ROC Curve; D012189:Retrospective Studies; D053719:Tandem Mass Spectrometry; D055815:Young Adult
chemical_list: D018395:CA-19-9 Antigen; D005231:Fatty Acids, Unsaturated; C000604757:PC-594 fatty acid
keywords: Biomarker; Blood; Fatty acid; Metabolite; PC-594; Pancreatic cancer; Risk; Screening