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Tomosynthesis as Primary Test for Breast Cancer Screening
Sponsor: Azienda USL Reggio Emilia - IRCCS
Summary
Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers.
Official title: Tomosynthesis as Primary Test for Breast Cancer Screening: A Multicenter Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
45 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
10156
Start Date
2019-07-15
Completion Date
2029-04-30
Last Updated
2025-06-25
Healthy Volunteers
Yes
Conditions
Interventions
tomosynthesis + synthetic 2D
Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.
digital mammography
Women will be screened for one round digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.
Locations (4)
Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
Reggio Emilia, Italy, Italy
IRCCS Policlinico San Donato
Milan, Italy
Azienda Ospedaliera Universitaria Integrata
Verona, Italy
Azienda Ulss 9 Scaligera
Verona, Italy