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OpenTrials
Active, Not Recruiting

NCT Number: NCT05731453

Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vestre Viken Hospital Trust

Drammen, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polygenetic risk score

Genetic

Polygenetic risk score assessment for breast cancer

Primary outcomes

  1. Assessment of breast cancer risk by polygenetic risk score in the study population

    Time frame: 10 years

    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

Secondary outcomes

  1. Compliance to individual recommedations for breast cancer screening

    Time frame: 10 years

    Percentage and frequencies of participants following their individual screening recommendations

  2. Correlation of polygenetic risk score and breast cancer risk assessed by family history

    Time frame: 10 years

    Distribution of PRS among participants with increased breast cancer risk based on family history

  3. Participants´ experience with study participation

    Time frame: 10 years

    Questionnaries on experience with the sampling process and feedback on a categorical scale (totally disagree, disagree, neutral, agree, totally agree)

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Collaborators

  • Oslo University Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2035
First posted
Feb 16, 2023
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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