BACKGROUND: Mammography is the only proven method for @entity0 screening that reduces mortality, although it is inaccurate in young @entity1 or @entity1 with dense breasts. We investigated the efficacy of adjunctive ultrasonography. METHODS: Between July, 2007, and March, 2011, we enrolled asymptomatic @entity1 aged 40-49 years at 42 study sites in 23 prefectures into the Japan Strategic Anti- @entity5 Randomized Trial (J-START). Eligible @entity1 had no history of any @entity5 in the previous 5 years and were expected to live for more than 5 years. Randomisation was done centrally by the Japan Clinical Research Support Unit. @entity1 were randomly assigned in 1:1 ratio to undergo mammography and ultrasonography (intervention group) or mammography alone (control group) twice in 2 years. The primary outcome was sensitivity, specificity, @entity5 detection rate, and stage distribution at the first round of screening. Analysis was by intention to treat. This study is registered, number UMIN000000757. FINDINGS: Of 72,998 @entity1 enrolled, 36,859 were assigned to the intervention group and 36,139 to the control group. Sensitivity was significantly higher in the intervention group than in the control group (91  1%, 95% CI 87  2-95  0 vs 77  0%, 70  3-83  7; p=0  0004), whereas specificity was significantly lower (87  7%, 87  3-88  0 vs 91  4%, 91  1-91  7; p<0  0001). More @entity5 were detected in the intervention group than in the control group (184 [0  50%] vs 117 [0  32%], p=0  0003) and were more frequently stage 0 and I (144 [71  3%] vs 79 [52  0%], p=0  0194). 18 (0  05%) interval @entity5 were detected in the intervention group compared with 35 (0  10%) in the control group (p=0  034). INTERPRETATION: Adjunctive ultrasonography increases sensitivity and detection rate of @entity5 . FUNDING: Ministry of Health, Labour and Welfare of Japan.

Sensitivity and specificity of mammography and adjunctive ultrasonography to screen for XXXX in the Japan Strategic Anti- @entity5 Randomized Trial (J-START): a randomised controlled trial.

@entity1 :: ('9606', 'Species') :: ['women', 'Participants'] @entity5 :: ('MESH:D009369', 'Disease') :: ['early cancers', 'cancers', 'cancer'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer']
@entity0 :: (MESH:D001943,Disease) :: ['breast cancer']
