What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer?
NCT04590560
Summary
Italian, multicenter, study aimed at defining the best interval for screening women 45-49 and 70-74 years for Breast Cancer (BC). This research project includes (1) a controlled, prospective randomized non-inferiority trial to determine the optimal screening interval for women aged 45-49, with and without high mammographic density, (2) a retrospective data collection, with the same purpose, on screening performed by women aged 70-74, and (3) a qualitative research to define the best communication strategy.
Eligibility
Inclusion Criteria: 1. Women invited for their first or second mammography (45 or 46 y/o) presenting for screening; 2. Willingness and ability to comply with scheduled visits; 3. Written informed consent obtained prior to performing any protocol-related procedures. Exclusion Criteria: 1. Pregnancy status; 2. Personal history of prior breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) diagnosis; 3. Ascertained heredo-familial risk according to the standard family history used in screening programs; 4. Participation in another clinical trial on BC screening; 5. Inability to provide signed informed consent.
Conditions2
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NCT04590560