Clinical trial · Interventional
What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer?
What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- 1-year screening interval
- description
- Women will follow the normal screening program (they will be invited to screen every year)
- type
- EXPERIMENTAL
- label
- 2-year screening interval
- description
- Women will be invited to screen every two years
- interventionNames
- Diagnostic Test: screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice
- type
- EXPERIMENTAL
- label
- 3-tailored screening interval
- description
- the screening interval will be decided on the basis of breast density. Women with very dense breast (BI-RADS category D) will be referred to 1-year interval whereas women with less dense breast to 2-year interval (BI-RADS category A, B, C)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 49 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available