Tomosynthesis as Primary Test for Breast Cancer Screening
-
- STATUS
- Recruiting
-
- End date
- Jun 30, 2026
-
- participants needed
- 8000
-
- sponsor
- Azienda Unità Sanitaria Locale Reggio Emilia
Summary
Randomized trial comparing
Description
This is a companion study of the other Italian studies on tomosyntesis as primary screening
test for
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
The investigators also will measure detection rates, specificity, interval
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.
Details
| Condition |
|
|---|---|
| Age | 45years - 65years |
| Treatment |
|
| Clinical Study Identifier | NCT04461808 |
| Sponsor | Azienda Unità Sanitaria Locale Reggio Emilia |
| Last Modified on | 19 February 2024 |
How to participate?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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