What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer?
Recruiting · NCT04590560 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice
What this trial is about
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.
Who can take part
Age range
45 Years to 49 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Women invited for their first or second mammography (45 or 46 y/o) presenting for screening;
- Willingness and ability to comply with scheduled visits;
- Written informed consent obtained prior to performing any protocol-related procedures.
Exclusion criteria
- Pregnancy status;
- Personal history of prior breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) diagnosis;
- Ascertained heredo-familial risk according to the standard family history used in screening programs;
- Participation in another clinical trial on BC screening;
- Inability to provide signed informed consent.
Where it is running
4 locations listed.
- Istituto per lo studio, la prevenzione e la rete oncologica (ISPRO) - Florence, Italy
- AUSL Romagna - Forlì, Italy
- AOU Città della Salute e della Scienza - Torino, Italy
- Irst Irccs - Meldola (FC), FC, Italy