Phase | I—Marker discovery | II—Assay development | III—Training and validation | III—Test | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pathology | Tissue | Plasma | Tissue | Plasma | Plasma | Plasma | |||||||
PDAC | Para-tumour | PDAC | Healthy | PDAC | Para-tumour | PDAC | Healthy | PDAC | CP | Healthy | PDAC | Healthy | |
Sample size | 46 | 28 | 20 | 123 | 27 | 17 | 29 | 55 | 94 | 25 | 80 | 74 | 65 |
Age (years) | |||||||||||||
 Median | 62 | 61 | 62 | 54 | 63 | 54 | 59 | 53 | 63 | 55 | 55 | 63 | 64 |
 pvalue | 0.1468* | <0.0001* | 0.0462* | 0.0042* | <0.0001** | 0.2721* | |||||||
 Range | 41–77 | 30–76 | 41–76 | 23–90 | 41–83 | 36–83 | 35–77 | 17–76 | 35–80 | 25–68 | 18–79 | 44–86 | 49–80 |
Gender: Male/female | 23/23 | 10/18 | 12/8 | 49/74 | 15/12 | 9/8 | 11/16 | 22/32 | 56/38 | 19/6 | 35/45 | 30/44 | 19/46 |
Clinical stage | |||||||||||||
 I | 14 | - | 7 | - | 10 | - | 6 | - | 23 | - | - | 3 | - |
 II | 15 | - | 7 | - | 9 | - | 14 | - | 47 | - | - | 51 | - |
 III/IV | 16 | - | 4 | - | 7 | - | 4 | - | 23 | - | - | 20 | - |
 N/A | 1 | - | 2 | - | 1 | - | 5 | - | 1 | - | - | 0 | - |
Tumour size (cm) | |||||||||||||
 Median | 3.4 | 2.5 | 2.8 | - | 2.9 | 2.7 | 3.3 | - | 3 | - | - | - | - |
 Range | 1.5–8.0 | 1.5–3.5 | 1.5–8 | - | 1.8–8.0 | 1.0–7.5 | 1.6–9.0 | - | 1.0–8.0 | - | - | - | - |
CA19-9 (U/ml) | |||||||||||||
 Median | 271.5 | 222 | - | - | 196.6 | 390.4 | 360.1 | - | 421.6 | 109.6 | 43 | 293 | - |
 Range | 0–3447 | 9–1514 | - | - | 0.6–1514 | 0.5–3447 | 2–1200 | - | 2–1200 | 1–1200 | 1–890 | 2–3386.5 | - |
 >37 | 26 | 6 | - | - | 11 | 7 | 21 | - | 50 | 2 | 4 | 15 | - |