Clinical trial · Interventional
Risk-Based Breast Screening in Young Women
Risk-Based Breast Screening (RIBBS) in Young Women: Personalized Imaging Protocols
- 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)
The RIBBS study is a single-arm single-center study that aims to evaluate the effectiveness of a risk-based breast screening model using digital breast tomosynthesis (DBT) as the baseline test, quantitative individual breast density to guide supplemental ultrasound (US) imaging for dense breasts, and individual risk (calculated taking into account breast density) to guide the screening interval (annual or biennial). Invited 45-year-old women are differentiated into five different screening protocols (based on breast density and risk), and screened according to a personalized model until they turn 50 and return to routine screening. The only primary endpoint in this study is the cumulative incidence of advanced breast cancers (stage II and above). This endpoint will be evaluated at the end of the five-year intervention period and at 10 years. The results of the personalized screening model will be compared with those obtained from an observational cohort from a neighboring region in which a "one-size-fits-all" approach involving annual mammography for women aged 45-49 years is used. The comparison will be conducted with the hypothesis of superiority of the personalized screening model.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Personalized screening protocol | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- RIBBS arm
- description
- This clinical trial is a single-arm study in which asymptomatic 45-year-old women undergo a triple screening test: (1) two-view tomosynthesis of both breasts; (2) calculation of volumetric breast density (VBD); (3) assessment of breast cancer risk using the Tyrer-Cuzick model. Mean VBD and lifetime risk (LTR) are used to determine the type of imaging and frequency of subsequent screening cycles.
- interventionNames
- Diagnostic Test: Personalized screening protocol
Primary outcomes (1)
- measure
- Cumulative Incidence of Advanced Cancers
- timeFrame
- Up to 15 years
- description
- Percentage of breast cancer cases diagnosed at staged II or beyond, either during the entire screening period or thereafter. Advanced cancers occurring up to 10 years after the end of the screening intervention will be included
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Aged 45 years old * Resident in the provinces of Padua and Rovigo (Italy) * Willing and able to give written informed consent * Willing and able to comply with scheduled visits, tests, and other procedures Exclusion Criteria: * Recent mammography * Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) * Known BRCA carrier or PALB2 or ≥50% risk * Psychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-up * Pregnant or breastfeeding * Unable to give informed consent * Current participation in another interventional breast screening trial
References
Publications (2)
- DERIVEDCaumo F, Gennaro G, Ravaioli A, Baldan E, Bezzon E, Bottin S, Carlevaris P, Ciampani L, Coran A, Dal Bosco C, Del Genio S, Dalla Pieta A, Falcini F, Maggetto F, Manco G, Masiero T, Petrioli M, Polico I, Pisapia T, Zemella M, Zorzi M, Zovato S, Bucchi L. Personalized screening based on risk and density: prevalence data from the RIBBS study. Radiol Med. 2025 May;130(5):740-752. doi: 10.1007/s11547-025-01981-5. Epub 2025 Mar 21. PMID 40117106
- DERIVEDGennaro G, Bucchi L, Ravaioli A, Zorzi M, Falcini F, Russo F, Caumo F. The risk-based breast screening (RIBBS) study protocol: a personalized screening model for young women. Radiol Med. 2024 May;129(5):727-736. doi: 10.1007/s11547-024-01797-9. Epub 2024 Mar 21. PMID 38512619