Clinical trial · Observational
FH-Risk 2.0: Updating Breast Cancer Risk Estimates
Recalculating Breast Cancer Risk and Exploring the Experience of Receiving Updated Breast Cancer Risk Estimates in Women With a Family History of 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)
In the UK women with a strong family history of breast cancer are eligible for breast cancer risk estimation via Family History Risk and Prevention Clinics (FHRPCs). Here breast cancer risk is calculated using popular risk prediction models like the Tyrer-Cuzick, CanRisk or Gail models. These models combine breast cancer risk factors to calculate a risk estimate for women. Risk factors include, family history, hormonal and reproductive factors, and risk factors related to health behaviours, for example, smoking, exercise and alcohol intake. Recently, risk estimation for breast cancer has become more accurate with the inclusion of mammographic density and Single Nucleotide Polymorphisms (SNPs) into popular risk prediction models. The addition of these new risk factors could alter the risk estimates that women in FHRPCs have been provided. How much these new risk factors alter a previously given risk estimate is unknown. It is also unknown how women will react to a revised risk estimate, especially if it changes their previous estimate and their access to preventive management options. This research aims to explore this gap in the literature.
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 Risk | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Notification of a revised breast cancer risk estimate | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women with a family history of breast cancer
- description
- This women are register to the Family History Risk and Prevention clinic and have taken part in the original FH-Risk study. These women will be given the opportunity to learn of their revised breast cancer risk estimate.
- interventionNames
- Other: Notification of a revised breast cancer risk estimate
Primary outcomes (3)
- measure
- To explore how much new risk models change breast cancer risk estimates
- timeFrame
- 1 - 2 years
- description
- How do new risk models which include mammographic density, SNPs and mutation testing change breast cancer risk estimates in women who are still registered at the family history clinic. Scatterplots and correlation coefficients will be used to examine the relationships between models and Bland-Altman plots used to show the agreement between the models.
- measure
- To compare breast cancer risk models
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * previously given informed consent to participate in the original FH-Risk study, * have an up to date clear mammogram, * aged between 25 and 60, * have not developed breast cancer and, * have the capacity to consent. Exclusion Criteria: * women who have received a diagnosis of breast cancer, * women who have not had a clear mammogram, * women who took part in the original FH-Risk study but did not consent for their data to be used in future research and, * women who lack the capacity to consent.
References
Publications (0)
Data not yet available