CanRisk-ClinGen: A multi-site randomised controlled trial of multifactorial risk assessment in NHS clinical genetics services

Not Applicable

• Conditions: Risk of breast cancer; Cancer

• Registration Number: ISRCTN11466065
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-19
• Last Update Posted: 2 September 2024
• Study Completion: 2027-02-14

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 2000

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in risk distribution measured using the CanRisk risk score