Tomosynthesis as Primary Test for Breast Cancer Screening
- Conditions
- Breast Cancer
- Registration Number
- NCT04461808
- Lead Sponsor
- Azienda USL Reggio Emilia - IRCCS
- 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 conduct a randomized trial in three centres with a protocol that is similar to that of the other three studies. As for IMPETO and differently from the RETomo and PROTEUS studies, the intervention will be tomosynthesis + synthetic 2D.
In the three centres about 8000 women will be recruited (4000 in the experimental arm and 4000 in the control arm).
The study will compare the performance of tomosynthesis plus synthetic 2D vs digital mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers. Women 50 to 65 years old will be screened once according to randomization arm for one round, then all will be screened with digital mammography after two years.
The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate excess overdiagnosis comparing overall cumulative incidence after two or three rounds of screening.
Women will be asked for informed consent when they attend the mammography. If 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 10156
- Women scheduled for a new round of mammographic screening
- resident in the province
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method advanced cancer incidence 4 years (+9 months to complete third round assessment) cumulative incidence of T2+ cancers after first screening round
interval cancer incidence 1 year for 45-49 years old women incidence of cancers occurring after a negative screening test and before the next scheduled screening round. Outcome 3 and 4 will are combined in one single outcome.
- Secondary Outcome Measures
Name Time Method detection rate This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered cancer detected by the screening round on total screened women
recall rate This outcome is measured at the baseline screening. number of women referred to assessment after the first leve screening test on total screened women
overall cumulative incidence 4 years (+9 months to complete second round assessment) overall cumulative incidence of breast cancer, including ductal carcinoma in situ. This outcome is a proxy of the excess over-diagnosis eventually induced by tomosynthesis compared with digital mammography.
positive predictive value This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered proportion of cancer among women recalled for assessment
Detection rate of ductal carcinoma in situ This outcome is measured at the baseline screening. cancer diagnosed within 9 months will be considered ductal carcinoma in situ detected by the screening round on total screened women
biopsy rate This outcome is measured at the baseline screening. number of women undergoing biopsy after the first leve screening test on total screened women
x-ray dose This outcome is measured at the baseline screening. average glandular dose receive by women during first level test
reading time This outcome is measured at the baseline screening. time needed to read an imaging first level examination
Trial Locations
- Locations (4)
IRCCS Policlinico San Donato
🇮🇹Milano, Italy
Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
🇮🇹Reggio Emilia, Italy
Azienda Ospedaliera Universitaria Integrata
🇮🇹Verona, Italy
Azienda Ulss 9 Scaligera
🇮🇹Verona, Italy
IRCCS Policlinico San Donato🇮🇹Milano, Italy