Risk of breast cancer Cancer
Conditions
Interventions
Current interventions as of 16/12/2025:
This study is a multi-site randomised controlled trial set in 14 NHS Clinical Genetics services and Family History clinics in England. Women referred to their l
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female 2. Aged 18-75 years 3. Referred with a family history of breast cancer; able to give informed consent 4. Referred with a family history of breast cancer 5. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Previous diagnosis and treatment for breast cancer 2. Known pathogenic variant in BRCA1, BRCA2, PALB2, ATM, CHEK2, RAD51C, RAD51D, BARD1 within their family 3. Previously undergone diagnostic genetic testing for BRCA1, BRCA2, PALB2, ATM, CHEK2, RAD51C, RAD51D, BARD1 4. Previously undergone multifactorial risk assessment (using CanRisk or another tool) incorporating risk factors, family history and genetic testing 5. Previously undergone risk-reducing surgery, has already participated in the CanRisk-GP study 6. Known pathogenic variant in BRCA1, BRCA2, PALB2, ATM, CHEK2, RAD51C, RAD51D, BARD1, within their family 7. Previously undergone diagnostic genetic testing for BRCA1, BRCA2, PALB2, ATM, CHEK2, RAD51C, RAD51D, BARD1 8. Previously undergone multifactorial risk assessment (using CanRisk or another tool (e.g. IBIS Breast Cancer Risk Evaluation Tool)) incorporating risk factors, family history and genetic testing (panel +/- PRS) 9. Previously undergone risk-reducing surgery (RRM/RRBSO)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in risk distribution measured using the CanRisk risk score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Uptake of available risk management interventions measured using outcome data provided by sites at the end of follow-up 2. Planned uptake of available risk management interventions measured using outcome data provided by sites at the end of follow-up 3. Psychosocial impact measured using questionnaires at baseline, 1, 4 and 12 months from the date of the risk score letter 4. Uptake of genetic testing in the intervention group measured using saliva samples provided by participants following the completion of MyCanRisk 5. Amount and completeness of information added to MyCanRisk in the intervention group measured using MyCanRisk data provided by participants at the time of completing MyCanRisk 6. Impact of confirming cancer diagnoses listed for family members within the family history section of MyCanRisk measured by comparing CanRisk score before and after cancer confirmations 7. Role of multifactorial risk assessment within the genetic counselling appointment measured using recordings of appointments following receipt of risk score 8. Acceptability of the early stratification pathway to patients and healthcare professionals measured using recruitment rates and questionnaires throughout the study 9. Cost-utility and cost-consequences of using the early stratification pathway measured using questionnaires completed at baseline, 1, 4 and 12 months and outcome data provided by sites | — |
Countries
England, United Kingdom
Contacts
Public ContactAmy;Amy Lafont;Lafont
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Outcome results
None listed