Breast Cancer Clinical Trial
Official title:
Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group
Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.
The investigators conduct a randomized trial (about 20000 tests in the intervention arm)
comparing the performance of tomosynthesis plus 2D Digital Mammography vs usual care (2D
digital mammography) in respect to incidence of advanced cancers (interval and following
round) and interval cancers. The investigators also will measure detection rates,
specificity, interval cancers, advanced cancers occurring as interval cancers or at
subsequent screens and allowing to estimate overdiagnosis. In Reggio Emilia a
population-based screening program is active. It invites all women from 45 to 74 years old
for a 2D digital mammography (2 projections, double reading) every 2 years (annually from 45
to 49).
Women will be asked for informed consent when they attend the mammography. I they accept
they will be randomised to one of the two arms.
All examinations will be read by two independent radiologists, in case of discordance a
third reading is asked.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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