Table 1.
Baseline patient characteristics.
| Discovery cohort | Validation cohort 1 | Validation cohort 2 | |
|---|---|---|---|
| Biliary tract cancer | |||
| Number of patients | 186 | 113 | 8 |
| Female | 104 (55.9) | 72 (63.7) | 3 (37.5) |
| Male | 82 (44.1) | 41 (36.3) | 5 (62.5) |
| Age (median [IQR]) | 67 [58, 71] | 66 [57, 73] | 77 [74, 83] |
| iCCA | 92 (49.5) | 38 (33.6) | 5 (62.5) |
| pCCA | 21 (11.3) | 18 (15.9) | 1 (12.5) |
| dCCA | 40 (21.5) | 30 (26.5) | 0 (0.0) |
| GBC | 33 (17.7) | 18 (15.9) | 2 (25.0) |
| Unknown location | 0 (0.0) | 9 (8.0) | 0 (0.0) |
| Resectable | 27 (14.5) | 13 (11.5) | 1 (12.5) |
| Locally advanced | 76 (40.9) | 21 (18.6) | 1 (12.5) |
| Metastatic disease | 83 (44.6) | 79 (69.9) | 6 (75.0) |
| PS 0 | 92 (49.5) | 43 (38.1) | 5 (62.5) |
| PS 1 | 78 (41.9) | 47 (41.6) | 1 (12.5) |
| PS 2 | 5 (2.7) | 20 (17.7) | 1 (12.5) |
| PS 3 | 0 (0.0) | 0 (0.0) | 1 (12.5) |
| Unknown PS | 11 (5.9) | 3 (2.7) | 0 (0.0) |
| CA19-9 (median [range]) |
188 [1, 297,000] |
145 [2, 101,263] |
29.50 [1, 3,280] |
| Healthy blood donors | |||
| Number of controls | 90 | 90 | 0 |
| Female | 45 (50.0) | 40 (44.4) | — |
| Male | 45 (50.0) | 50 (55.6) | — |
| Age (median [IQR]) | 62 [57, 65] | 63 [56, 65] | — |
| CA19-9 (median [range]) |
3.00 [1, 159] |
2.00 [1, 35] |
|
| Benign biliary tract disease | |||
| Number of patients | 24 | 24 | 0 |
| Female | 17 (70.8) | 18 (75.0) | — |
| Male | 7 (29.2) | 6 (25.0) | — |
| Age (median [IQR]) | 47 [36, 60] | 46 [38, 62] | — |
| PS 0 | 19 (79.2) | 20 (83.3) | — |
| PS 1 | 3 (12.5) | 2 (8.3) | — |
| PS 2 | 2 (8.3) | 2 (8.3) | — |
| PS 3 | 0 (0.0) | 0 (0.0) | — |
| CA19-9 (median [range]) |
6.00 [1,34] |
6.50 [1,36] |
|
| MICA study: non-cancer controls∗ | |||
| Number of patients | 135 | 127 | 132 |
| Female | 78 (57.8) | 72 (56.7) | 80 (60.6) |
| Male | 57 (42.2) | 55 (43.3) | 52 (39.4) |
| Age (median [IQR]) | 60 [50, 70] | 65 [54, 72] | 68 [57, 73] |
| PS 0 | 124 (91.9) | 109 (85.8) | 100 (75.8) |
| PS 1 | 8 (5.9) | 18 (14.2) | 25 (18.9) |
| PS 2 | 2 (1.5) | 0 (0.0) | 7 (5.3) |
| PS 3 | 1 (0.7) | 0 (0.0) | 0 (0.0) |
| CA19-9 (median [range]) | 9 [1, 4440] | 9 [1, 315] | 1 [1, 723] |
CA19-9, carbohydrate antigen 19-9; dCCA, distal cholangiocarcinoma; iCCA, intrahepatic cholangiocarcinoma; pCCA, perihilar cholangiocarcinoma; GBC, gallbladder cancer; PS, performance status.
∗
Participants referred due to symptoms raising suspicion of possible cancer, but no cancer detected after a minimum of 2 years.