Table 1.

Demographic and clinicopathologic characteristics of discovery (phase I) and validation study cohorts

Phase IValidation
Noncancer (%)aCancer (%)Noncancer (%)aCancer (%)
n = 46n = 54n = 35n = 35
Median age (range, y)56 (20–77)71 (48–89)58 (19–85)67 (20–87)
Male/female ratio35:1147:728:1334:7
Race
 White35 (76)53 (98)34 (83)41 (100)
 African American6 (13)1 (2)3 (7)0 (4)
 Other5 (11)0 (0)4 (10)0 (0)
Positive/suspicious cytology0 (0)16 (30)0 (0)11 (31)
Clinical stage
 Tisn/a4 (7)n/a0 (0)
 Tan/a9 (17)n/a14 (34)
 T1n/a11a (20)n/a9 (22)b
 T2n/a22 (41)n/a17 (41)b
 T3n/a2 (4)n/a1 (2)
 T43 (6)1 (2)
 Tx1 (2)0
Grade
 1/2n/a9 (17)n/a10 (24)
 3n/a45 (83)n/a31 (76)

Abbreviation: n/a, not available.

  • aOne patient with carcinoma in situ.

  • bOne patient each with carcinoma in situ.