Table 1.

Clinical and demographic data of the retrospective training and prospective validation cohort of patients that were used for the establishment and validation of a logistic regression model combining bile and urine proteome analysis for cholangiocarcinoma diagnosis.

	Logit model establishment (fitting and bootstrapping)			Prospective validation
Study phase	CC	PSC/BBD	p *	CC	PSC/BBD	p *
Patient group
Patients, n	36	51		16	29
Type of biliary disease (n)
CC	23			10
CC on-top-of PSC	13			6
PSC		33			28
Choledocholithiasis		10
Chronic pancreatitis		3
SSC		3
CBD dilatation		2			1
Clinical and demographic parameters (normal values)
Age, years, mean/range	56/25–80	52/21–84	0.16	60/22–85	40/23–68	0.0001
Female/male, n/n	10/26	14/37	1	5/11	8/21	1
Alkaline phosphatase (35–104 U/L), mean/range	417/96–1023	264/47–1475	0.0001	280/61–483	314/88–986	0.53
γ-Glutamyltransferase (<39 U/L), mean/range	474/59–1302	247/15–1340	0.0004	456/10–2212	498/27–3638	0.53
Bilirubin (<17 µmol/L), mean/range	159/5–506	33/4–225	<0.0001	36/4–176	62/4–260	0.09
Leucocyte count (4–10/nL), mean/range	8628/3600–20800	6531/2300–11600	0.04	8160/840–15700	8195/1000–20000	0.97
C-reactive protein (<8 mg/L), mean/range	49/2–215	17/1–190	0.0002	23/1–151	19/1–91	0.9
Alanine aminotransferase (<5 U/L), mean/range	153/14–716	67/16–331	0.002	94/17–348	105/15–548	0.86
Aspartate aminotransferase (<32 U/L), mean/range	139/23–767	60/6–378	<0.0001	65/18–186	87/16–375	0.33
Carbohydrate antigen 19-9 (<27 kU/L), mean/range	3503/1–81,243	68/1–543	0.0001	619/7–3098	84/1–293	0.006
Number of detected peptides
in urine, mean/range	1928/750–3800	1876/969–2940	0.93	2092/877–3116	2156/946–3036	0.69
in bile, mean/range	1667/320–4488	1899/327–4165	0.19	1641/751–2792	1566/520–3179	0.64

^*Two-tailed probability for continuous data and significance level by Fisher exact test for categorical data.

Abbreviations: BBD, benign biliary disorder; CBD, common bile duct; CC, cholangiocarcinoma; PSC, primary sclerosing cholangitis; SSC, secondary sclerosing cholangitis.