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ACTIVE NOT RECRUITING
NCT04461808
NA

Tomosynthesis as Primary Test for Breast Cancer Screening

Sponsor: Azienda USL Reggio Emilia - IRCCS

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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