Our objective was to identify factors that correlate with CA125 concentrati
ons in healthy postmenopausal women and to introduce recommendations for re
porting and interpreting individual CA125 assay results. We analyzed repeat
ed serum CA125 levels, as measured by the CA125II assay, in 18,748 postmeno
pausal women who participated in the St. Bartholomew's/Royal London Hospita
l Ovarian Cancer screening trial from 1986 to 1994 and were not diagnosed w
ith ovarian cancer during the l2-year follow-up period. We found that race
is a substantial predictor of normal levels of CA125, with average CA125II
concentration from African (median, 9.0; 95% range, 4.0-26.0 units/ml) and
Asian women (median, 13.0; range, 5.9-33.3 units/ml) lower than that in Cau
casian women (median, 14.2; range, 6.0-41.0 units/ml; P < 0.001). Women wit
h a hysterectomy have lower CA125II values (median, 13.6; range 5.5-39.0 un
its/ml; P < 0.001), and women with a prior cancer diagnosis other than ovar
ian cancer have higher levels of CA125 II (median, 16.0; range, 6.0-49.0 un
its/ml; P < 0.003), Regular smoking and caffeine consumption decrease CA125
levels (P < 0.001). A woman's age, age at menarche, age at menopause, and
history of a previous ovarian cyst (P < 0.05) are also predictive of baseli
ne CA125 levels. Parity, history of hormone replacement therapy or unilater
al oopherectomy, and previous use of oral contraceptives or talcum powder a
re not significant predictors of CA125 concentrations (P > 0,05). We conclu
ded that clinically significant differences in individual patient character
istics need to be reflected in the screening algorithms that use CA125II so
that designed performance characteristics (sensitivity and specificity) ar
e maintained in practice.