Status:
ACTIVE_NOT_RECRUITING
Tomosynthesis as Primary Test for Breast Cancer Screening
Lead Sponsor:
Azienda USL Reggio Emilia - IRCCS
Collaborating Sponsors:
AULSS 9 Scaligera di Verona
IRCCS Policlinico S. Donato, Milano
Conditions:
Breast Cancer
Eligibility:
FEMALE
45-65 years
Phase:
NA
Brief 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.
Detailed Description
This is a companion study of the other Italian studies on tomosyntesis as primary screening test for breast cancer: RETomo (NCT02698202), PROTEUS (NCT02590315), IMPETO (NCT03587259). The investigators...
Eligibility Criteria
Inclusion
- Women scheduled for a new round of mammographic screening
- resident in the province
Exclusion
- previous breast cancer diagnosis
- pregnancy or suspicion of pregnancy
- presence of BRCA1/2 gene mutation
- Previous Digital Breast Tomosynthesis performed
- unable to understand informed consent
- chemotherapy in progress
- presence of breast implant
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2029
Estimated Enrollment :
10156 Patients enrolled
Trial Details
Trial ID
NCT04461808
Start Date
July 15 2019
End Date
April 30 2029
Last Update
June 25 2025
Active Locations (4)
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1
Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
Reggio Emilia, Italy, Italy, 42122
2
IRCCS Policlinico San Donato
Milan, Italy
3
Azienda Ospedaliera Universitaria Integrata
Verona, Italy
4
Azienda Ulss 9 Scaligera
Verona, Italy