Table 1.
Baseline Characteristics by Stage (Discovery/Validation Cohort)
| Characteristics | Stage 1 (discovery cohort) | Stage 2 (validation cohort) | ||||
|---|---|---|---|---|---|---|
| PAG (N = 52) | AG (N = 42) | Total (N = 94) | PAG (N = 65) | AG (N = 30) | Total (N = 95) | |
| Mean age (min–max), years | 62.5 (28–77) | 66.8 (54–76) | 64.4 (28–77) | 64.7 (40–83) | 63.3 (44–80) | 64.3 (40–83) |
| Sex, n (%) | ||||||
| Female | 19 (36.5) | 23 (54.8) | 42 (44.7) | 26 (40.0) | 16 (53.3) | 42 (44.2) |
| Male | 33 (63.5) | 19 (45.2) | 52 (55.3) | 39 (60.0) | 14 (46.7) | 53 (55.8) |
| Race, n (%) | ||||||
| White | 47 (90.4) | 33 (78.6) | 80 (85.1) | 58 (89.2) | 24 (80.0) | 82 (86.3) |
| Black or African American | 3 (5.8) | 7 (16.7) | 10 (10.6) | 4 (6.2) | 1 (3.3) | 5 (5.3) |
| Asian | 0 (0.0) | 1 (2.4) | 1 (1.1) | 2 (3.1) | 3 (10.0) | 5 (5.3) |
| Multiple | 0 (0.0) | 1 (2.4) | 1 (1.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| American Indian or Alaska Native | 1 (1.9) | 0 (0.0) | 1 (1.1) | 0 (0.0) | 0 (0.0) | 0 (0,0) |
| Native Hawaiian or Other Pacific Islander | 1 (1.9) | 0 (0.0) | 1 (1.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Other | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (6.7) | 2 (2.1) |
| Primary tumor location (pancreas), n (%) | ||||||
| Body | 26 (50.0) | 16 (38.1) | 42 (44.7) | 26 (40.0) | 12 (40.0) | 38 (40.0) |
| Head | 16 (30.8) | 17 (40.5) | 33 (35.1) | 29 (44.6) | 16 (53.3) | 45 (47.4) |
| Tail | 10 (19.2) | 9 (21.4) | 19 (20.2) | 10 (15.4) | 2 (6.7) | 12 (12.6) |
| Tumor biopsy site, n (%) | ||||||
| Liver | 40 (76.9) | 23 (54.8) | 63 (67.0) | 39 (60.0) | 18 (60.0) | 57 (60.0) |
| Pancreas | 6 (11.5) | 9 (21.4) | 15 (16.0) | 10 (15.4) | 7 (23.3) | 17 (17.9) |
| Lung | 1 (1.9) | 2 (4.8) | 3 (3.2) | 2 (3.1) | 1 (3.3) | 3 (3.2) |
| Duodenum | 1 (1.9) | 1 (2.4) | 2 (2.1) | 2 (3.1) | 0 (0.0) | 2 (2.1) |
| Omentum | 1 (1.9) | 1 (2.4) | 2 (2.1) | 1 (1.5) | 0 (0.0) | 1 (1.1) |
| Lymph node | 1 (1.9) | 0 (0.0) | 1 (1.1) | 1 (1.5) | 0 (0.0) | 1 (1.1) |
| Abdomen | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.5) | 0 (0.0) | 1 (1.1) |
| Abdominal cavity | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.5) | 0 (0.0) | 1 (1.1) |
| Ampulla | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.5) | 0 (0.0) | 1 (1.1) |
| Peritoneum | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.5) | 0 (0.0) | 1 (1.1) |
| Papilla | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (3.3) | 1 (1.1) |
| History of diabetes, n (%) | 18 (34.6) | 18 (42.9) | 36 (38.3) | 19 (29.2) | 13 (43.3) | 32 (33.7) |
| C3M | ||||||
| Mean | 11.0 | 11.2 | 11.1 | 8.8 | 8.8 | 8.8 |
| Range | 15.7 | 28.5 | 28.5 | 13.0 | 9.5 | 13.2 |
| Below LLOQ (< 1.9 ng/mL), No. | 0 | 0 | 0 | 0 | 0 | 0 |
| Above ULOQ (> 54.2 ng/mL), No. | 0 | 0 | 0 | 0 | 0 | 0 |
| PRO-C3 | ||||||
| Mean | 32.2 | 35.7 | 33.7 | 27.8 | 24.1 | 26.7 |
| Range | 353.3 | 159.9 | 353.3 | 183.6 | 97.6 | 183.6 |
| Below LLOQ (< 4 ng/mL), No. | 0 | 0 | 0 | 0 | 0 | 0 |
| Above ULOQ (> 107.6 ng/mL), No. | 1 | 4 | 5 | 1 | 0 | 1 |
| C3M/PRO-C3 ratio | ||||||
| Mean | 0.68 | 0.57 | 0.63 | 0.56 | 0.58 | 0.56 |
| Range | 1.73 | 2.29 | 2.29 | 2.13 | 1.74 | 2.13 |
Table shows demographics and clinical characteristics of patients for whom baseline plasma samples were available
Where range is provided as a single number, it represents the difference between the lowest and highest value
LLOQ: lower limit of quantification; ULOQ: upper limit of quantification