Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

Breast Cancer Clinical Trial

Official title:

Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05731453
• Other study ID #: 494936
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: November 11, 2035

Study information

• Verified date: May 2024
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate the impact of implementing population-based genetics testing strategy for breast cancer precision prevention using the polygenic risk score and monogenic pathogenic variant (MPV) testing in the Norwegian healthcare setting.

Description:

The study will recruit women age 40-50 referred for clinical mammography at the Vestre Viken Breast Center, with mammographic density BI-RADS a or d. After informed consent, saliva from the participants will be sampled and tested for polygenetic risk score (PRS) for breast cancer. The participants will be recommended future mammographic screening based on the PRS (standard screening, or more frequent/start at earlier age). The participants family history of cancer will be assessed, and if indicated, the participants will be referred for full genetic counselling/testing. The study will follow the women for 10 years for development of breast cancer as well as compliance to the recommended follow-up.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: November 11, 2035
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women referred for clinical mammography in the Vestre Viken Breast Centre

• Breast density BI-RADS a or d

• 40-50 y.o.

Exclusion Criteria:

• Prior history of breast cancer or premalignant breast disease

• Prior genetic counselling/testing

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• Polygenetic risk score
Polygenetic risk score assessment for breast cancer

Locations

Country	Name	City	State
Norway	Vestre Viken Hospital Trust	Drammen

Sponsors (2)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of breast cancer risk by polygenetic risk score in the study population	Polygenetic breast cancer risk score (PRS) as a numeric value with 10 percentile, as absolute 10-year breast cancer risk, and as relative risk compared with average women at the same age	10 years
Secondary	Compliance to individual recommedations for breast cancer screening	Percentage and frequencies of participants following their individual screening recommendations	10 years
Secondary	Correlation of polygenetic risk score and breast cancer risk assessed by family history	Distribution of PRS among participants with increased breast cancer risk based on family history	10 years
Secondary	Participants´ experience with study participation	Questionnaries on experience with the sampling process and feedback on a categorical scale (totally disagree, disagree, neutral, agree, totally agree)	10 years