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FH-Risk 2.0: Updating Breast Cancer Risk Estimates

NCT05082740 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 333

Last updated 2024-03-26

No results posted yet for this study

Summary

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

  • Breast Cancer Risk

Interventions

OTHER

Notification of a revised breast cancer risk estimate

These women will be given the opportunity to learn of their revised breast cancer risk estimate which has been re-calculated with the inclusion of new strong independent risk factors. These women will be offered a clinical consultation to discuss their risk and will a subset will be asked to take part in a qualitative interview about their experiences.

Sponsors & Collaborators

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV

  • University of Manchester

    lead OTHER

Principal Investigators

  • Gareth Evans · Manchester University NHS Foundation Trust

  • Anthony Howell · Manchester University NHS Foundation Trust

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-04-18
Completion
2023-09-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05082740 on ClinicalTrials.gov