Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT02698202
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2016-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Breast Cancer With Digital Breast Tomosynthesis
Sponsor:
Azienda USL Reggio Emilia - IRCCS
Organization:
Study Overview
Official Title:
Randomized Controlled Trial to Evaluate the Efficacy of Digital Breast Tomosynthesis in Reggio Emilia Breast Cancer Screening Program in the 45-74 Age Group
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Randomized trial comparing the performance of tomosynthesis and 2D Digital Mammography vs 2D Digital Mammography only in respect to incidence of advanced cancers (interval and following round) and interval cancers.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: