Clinical trial · Observational
Breast CANcer Risk Assessment in Younger Women: BCAN-RAY
A Case Control Study of Women Aged 30-39 to Augment Breast Cancer Risk Prediction and Assess Acceptability and Preference of a Systematic Risk Prediction Approach Through Primary Care
- 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 overarching aim of the proposed research is to develop a comprehensive breast cancer risk assessment strategy for women aged 30-39 years. There are three main objectives to the study. Objective 1 - Mammographic Density and Risk To define the magnitude of BC risk associated with MD in women aged 30-39 and facilitate its incorporation into risk prediction models. Objective 2 - Psychological impact To examine the feasibility of a strategy to offer breast cancer risk-assessment to diverse ethnic and socioeconomic populations of women in their 30s, assessing: * Potential benefits and harms * Impact on health inequalities * Acceptability Objective 3 - DNA Methylation substudy To explore the potential of DNA Methylation (DNAme) signatures from self-obtained cervical samples to further refine risk prediction algorithms
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 Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mammogram | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Case
- description
- 250 women diagnosed with BC when they were aged 30-39 years
- interventionNames
- Radiation: Mammogram
- label
- Control
- description
- 750 controls currently aged 30-39 years
- interventionNames
- Radiation: Mammogram
Primary outcomes (2)
- measure
- Mammographic Density and Risk
- timeFrame
- 24 months
- description
- To define the magnitude of BC risk associated with MD in women aged 30-39 and facilitate its incorporation into risk prediction models.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 39 Years
Show eligibility criteria text
4.1 Inclusion Criteria 4.1.1 Main study The following criteria must be met for entry to the main case control study: 4.1.1.1 Cases * Born biologically female * Aged 30-39 years when diagnosed with breast cancer * Able to provide informed consent 4.1.1.2 Controls * Born biologically female * Aged 30-39 years * Able to provide informed consent 4.1.2 Acceptability Substudy All control participants that are eligible for the main study are eligible for inclusion in the acceptability substudy. 4.1.3 DNA methylation substudy Case participants will only be eligible for the DNAme substudy if they fulfill all eligibility criteria for the main study and the following inclusion criterion: • Yet to receive any systemic therapy for early breast cancer (chemotherapy, endocrine therapy or targeted therapy eg trastuzumab (Herceptin)) All control participants are eligible for the DNAme substudy if eligibility criteria are met for the main study.
References
Publications (1)
- DERIVEDHindmarch S, Howell SJ, Usher-Smith JA, Gorman L, Evans DG, French DP. Feasibility and acceptability of offering breast cancer risk assessment to general population women aged 30-39 years: a mixed-methods study protocol. BMJ Open. 2024 Jan 10;14(1):e078555. doi: 10.1136/bmjopen-2023-078555. PMID 38199637