FH-Risk 2.0: Updating Breast Cancer Risk Estimates

NCT05082740 | Completed

• 1 other identifier: FH-Risk 2.0 Research Protocol
• Study Type: observational
• Target: 333
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• To explore how much new risk models change breast cancer risk estimates

  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.

  1 - 2 years

• To compare breast cancer risk models

  Comparing the risk estimations given by the Tyrer-Cuzick and CanRisk models. 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.

  1 - 2 years

• To explore women's risk appraises and experiences of receiving a revised breast cancer risk estimate

  How do women react to receiving a revised breast cancer risk estimate, especially if their risk has changed. What are their risk perceptions following a revised estimate. This will assessed through qualitative interviews.

  Through to study completion, 2.5 years

Study Arms (1)

Women with a family history of breast cancer

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.

Other: Notification of a revised breast cancer risk estimate

Interventions

Notification of a revised breast cancer risk estimate OTHER

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.

Women with a family history of breast cancer

Eligibility Criteria

• Age: 25 Years - 60 Years
• Gender Eligibility Details: Must identify as a woman and be born female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women in study will have taken part in the original FH-Risk study and who are still under follow up at the family history clinic or who have been discharged. These women will have had no history of breast cancer themselves. Women will be between the ages of 25 and 60.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, M23 9QZ, United Kingdom

Location

Study Officials

• Gareth Evans

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Anthony Howell

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Miss

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 19, 2021
• Study Start: March 1, 2022
• Primary Completion: April 18, 2023
• Study Completion: September 29, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)