Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

February 16, 2023 updated by: Vestre Viken Hospital Trust
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polygenetic risk score
Assessment of polygenetic risk score for breast cancer
Genetic: Polygenetic risk score
Polygenetic risk score assessment for breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance to individual recommedations for breast cancer screening
Time Frame: 10 years
Percentage and frequencies of participants following their individual screening recommendations
10 years
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
10 years
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)
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vestre Viken Hospital Trust

Collaborators

Oslo University Hospital

Investigators

  • Principal Investigator: Tone Hovda, Phd, Vestre Viken HT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

November 11, 2035

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 494936

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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