Screening for Breast Cancer With Digital Breast Tomosynthesis
Açar sözlər
Mücərrəd
Təsvir
The investigators conduct a randomized trial (about 20000 tests in the intervention arm) comparing the performance of tomosynthesis plus 2D Digital Mammography vs usual care (2D digital mammography) in respect to incidence of advanced cancers (interval and following round) and interval cancers. The investigators also will measure detection rates, specificity, interval cancers, advanced cancers occurring as interval cancers or at subsequent screens and allowing to estimate overdiagnosis. In Reggio Emilia a population-based screening program is active. It invites all women from 45 to 74 years old for a 2D digital mammography (2 projections, double reading) every 2 years (annually from 45 to 49).
Women will be asked for informed consent when they attend the mammography. I 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.
Tarixlər
| Son Doğrulandı: | 02/29/2016 |
| İlk təqdim: | 02/25/2016 |
| Təxmini qeydiyyat təqdim edildi: | 02/25/2016 |
| İlk Göndərmə: | 03/02/2016 |
| Son Yeniləmə Göndərildi: | 03/02/2016 |
| Son Yeniləmə Göndərildi: | 03/03/2016 |
| Həqiqi Təhsilin Başlama Tarixi: | 02/28/2014 |
| Təxmini İlkin Tamamlanma Tarixi: | 11/30/2016 |
| Təxmini İşin Tamamlanma Tarixi: | 11/30/2018 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Device: Digital Breast Tomosynthesis
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| Experimental: Digital Breast Tomosynthesis to the experimental arm will be offered twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis | Device: Digital Breast Tomosynthesis twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis |
| No Intervention: standard mammography to the control arm the usual 2D standard mammography exam will be offered |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 45 Years Üçün 45 Years |
| Təhsilə Uyğun Cinslər | Female |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | Inclusion Criteria: 45-70 years old women invited to breast cancer screening program who accepted to participate Exclusion Criteria: - 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 |
Nəticə
İlkin nəticə tədbirləri
1. cumulative incidence of T2+ cancers after screening [2 years]
2. incidence of interval cancers [2 years]
İkincili Nəticə Tədbirləri
1. Detection rate [2 years]
2. recall rate [baseline]
3. Positive Predictive value [baseline]
4. diagnostic agreement between tomosynthesis and 2d mammography [baseline]
5. Detection rate of in situ ductal carcinoma [2 years]
6. biopsy rate [baseline]
7. self-reported pain and discomfort during mammography [baseline]
8. x-ray dose [baseline]
