Breast Cancer RiskNCT05082740
FH-Risk 2.0: Updating Breast Cancer Risk Estimates
An observational study of Breast Cancer Risk, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Risk
- What is being tested?
- Notification of a revised breast cancer risk estimate
- How many people
- 333 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2022to 29 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, Greater Manchester, M23 9QZ
About this study
Official title: Recalculating Breast Cancer Risk and Exploring the Experience of Receiving Updated Breast Cancer Risk Estimates in Women With a Family History of Breast Cancer
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.
Read the detailed description
Estimation of breast cancer risk is important since it enables selection of a high and moderate risk population who benefit from more frequent breast screening and the introduction of targeted measures to reduce risk such as lifestyle change, chemoprevention and risk reducing surgery. Traditionally, risk is estimated by combining information concerning family history and non-familial factors, such as age of menarche and first pregnancy. Subsequent management is related to the degree of risk (high, moderate or average) according to NICE guidelines. Members of the research team and others have added mammographic density (MD) and breast cancer risk associated single nucleotide polymorphisms (SNPs) to risk models which improves the accuracy of risk estimation but which may change the original given risk and risk management given before the updated models became available.
The objective of this body of work is to quantify change in risk and risk management when MD and SNPs are incorporated into two standard models (Tyrer-Cuzick v8 \& BOADACEA V). A second objective of the study is to determine the psychological effects of change of risk and management.
This work will use participant data from the Family History Risk (FH-Risk) study to recalculate risk. The FH-Risk study population consists of 954 women referred to the Family History Risk and Prevention Clinic (FHRPC) between 2000 and 2012 who gave informed consent for DNA testing and estimation of MD as part of the FH-Risk study which recruited between 2010 and 2012. Change in risk and management will be calculated by comparing given risk at the time of clinic entry compared with re-estimated risk when MD and SNPs are added to the risk models according to NICE guidelines. Risk will be estimated retrospectively at the time of entry to the clinic and the time of latest follow up.
A sample of those who took part in the FH-Risk study who are still in the FHRPC for follow-up or discharged (approx.954) will be given the opportunity to discuss their updated risk.
Following the risk update consultation a sample of women will be asked whether they would like to take part in an interview to assess the psychological effects of the change, as well as their views and perceptions of the change. These interviews will inform the development of information materials for communicating recalculated risk. These materials will be appraised via 'think aloud' interviews with women from the FH-Risk study who have received their recalculated risk.
The results of this work are likely to inform the next iteration of NICE management guidelines for Family History Clinics, as well as inform the creation of patient facing information materials to aid patient - healthcare professional communication. The findings will also be used to develop a questionnaire to be given to women who previously took part in the FH-Risk study to assess the psychological impact of changed risk in a definitive study.
This body of work is split into 3 studies:
Study 1 - risk recalculation
Risk recalculation will be performed for all women who took part in the original FH-Risk study, with all women (still under follow up at the FHRPC or discharged) given the opportunity to attend a consultation to discuss their revised breast cancer risk estimate.
Study 2 - women's experiences of receiving a revised breast cancer risk estimate.
One to one semi-structured interviews will be conducting with women from study 1 to explore their experiences of receiving a revised breast cancer risk estimate. Breast cancer risk appraisals, the trustworthiness of the estimate, women's emotional responses will all be considered in these interviews. Information and communication needs will also be explored.
Study 3 - a questionnaire study assessing for whether women's subjective risk appraisals are inline with the revised risk estimate provided.
A questionnaire will be distributed to women in the study and they will be asked about their subjective risk appraisals, their thoughts on whether risk has changed, their satisfaction with the risk communicated and their cancer worry.
- Conditions
- Breast Cancer Risk
- Being tested
- Notification of a revised breast cancer risk estimate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Notification of a revised breast cancer risk estimateOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Notification of a revised breast cancer risk estimate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Through to study completion, 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Mar 2022
- Primary completion18 Apr 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer RiskStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Responsible party
- Principal investigator, Victoria Woof, University of Manchester
- Investigators
- Gareth Evans, Principal investigator, Manchester University NHS Foundation TrustAnthony Howell, Principal investigator, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082740
- Sponsor's protocol ID
- FH-Risk 2.0 Research Protocol
- Status last verified
- Mar 2024
- First submitted
- 24 Sep 2021
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data from the study will be shared with other researchers on request. Data will included, an anonymised data set of women's breast cancer risk and anonymised interview transcripts. Women in the study will not be identifiable to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recalculating Breast Cancer Risk and Exploring the Experience of Receiving Updated Breast Cancer Risk Estimates in Women With a Family History of Breast Cancer
- ClinicalTrials.gov ID
- NCT05082740
- Acronym / sponsor ID
- FH-Risk 2.0 Research Protocol
- Conditions
- Breast Cancer Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Estimation of breast cancer risk is important since it enables selection of a high and moderate risk population who benefit from more frequent breast screening and the introduction of targeted measures to reduce risk such as lifestyle change, chemoprevention and risk reducing surgery. Traditionally, risk is estimated by combining information concerning family history and non-familial factors, such as age of menarche and first pregnancy. Subsequent management is related to the degree of risk (high, moderate or average) according to NICE guidelines. Members of the research team and others have added mammographic density (MD) and breast cancer risk associated single nucleotide polymorphisms (SNPs) to risk models which improves the accuracy of risk estimation but which may change the original given risk and risk management given before the updated models became available.
The objective of this body of work is to quantify change in risk and risk management when MD and SNPs are incorporated into two standard models (Tyrer-Cuzick v8 \& BOADACEA V). A second objective of the study is to determine the psychological effects of change of risk and management.
This work will use participant data from the Family History Risk (FH-Risk) study to recalculate risk. The FH-Risk study population consists of 954 women referred to the Family History Risk and Prevention Clinic (FHRPC) between 2000 and 2012 who gave informed consent for DNA testing and estimation of MD as part of the FH-Risk study which recruited between 2010 and 2012. Change in risk and management will be calculated by comparing given risk at the time of clinic entry compared with re-estimated risk when MD and SNPs are added to the risk models according to NICE guidelines. Risk will be estimated retrospectively at the time of entry to the clinic and the time of latest follow up.
A sample of those who took part in the FH-Risk study who are still in the FHRPC for follow-up or discharged (approx.954) will be given the opportunity to discuss their updated risk.
Following the risk update consultation a sample of women will be asked whether they would like to take part in an interview to assess the psychological effects of the change, as well as their views and perceptions of the change. These interviews will inform the development of information materials for communicating recalculated risk. These materials will be appraised via 'think aloud' interviews with women from the FH-Risk study who have received their recalculated risk.
The results of this work are likely to inform the next iteration of NICE management guidelines for Family History Clinics, as well as inform the creation of patient facing information materials to aid patient - healthcare professional communication. The findings will also be used to develop a questionnaire to be given to women who previously took part in the FH-Risk study to assess the psychological impact of changed risk in a definitive study.
This body of work is split into 3 studies:
Study 1 - risk recalculation
Risk recalculation will be performed for all women who took part in the original FH-Risk study, with all women (still under follow up at the FHRPC or discharged) given the opportunity to attend a consultation to discuss their revised breast cancer risk estimate.
Study 2 - women's experiences of receiving a revised breast cancer risk estimate.
One to one semi-structured interviews will be conducting with women from study 1 to explore their experiences of receiving a revised breast cancer risk estimate. Breast cancer risk appraisals, the trustworthiness of the estimate, women's emotional responses will all be considered in these interviews. Information and communication needs will also be explored.
Study 3 - a questionnaire study assessing for whether women's subjective risk appraisals are inline with the revised risk estimate provided.
A questionnaire will be distributed to women in the study and they will be asked about their subjective risk appraisals, their thoughts on whether risk has changed, their satisfaction with the risk communicated and their cancer worry.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with a family history of breast cancer | – | Other: Notification of a revised breast cancer risk estimateThis 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Notification of a revised breast cancer risk estimateThese 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. | Other | Women with a family history of breast cancer |
Primary outcome
To explore how much new risk models change breast cancer risk estimates
Time frame: 1 - 2 years
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.
To compare breast cancer risk models
Time frame: 1 - 2 years
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.
To explore women's risk appraises and experiences of receiving a revised breast cancer risk estimate
Time frame: Through to study completion, 2.5 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: Yes. Anonymised data from the study will be shared with other researchers on request. Data will included, an anonymised data set of women's breast cancer risk and anonymised interview transcripts. Women in the study will not be identifiable to other researchers.
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RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gareth Evans principal investigator
Manchester University NHS Foundation Trust
Anthony Howell principal investigator
Manchester University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Risk, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore how much new risk models change breast cancer risk estimates (time frame: 1 - 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.