NCT05731453

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
116mo left

Started Feb 2023

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Feb 2023Nov 2035

First Submitted

Initial submission to the registry

January 10, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
11.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2035

Expected
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

January 10, 2023

Last Update Submit

May 22, 2024

Conditions

Breast Cancer

Keywords

risk based screening

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Compliance to individual recommedations for breast cancer screening

    10 years

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

    10 years

  • Participants´ experience with study participation

    10 years

Study Arms (1)

Polygenetic risk score

EXPERIMENTAL

Assessment of polygenetic risk score for breast cancer

Genetic: Polygenetic risk score

Interventions

Polygenetic risk scoreGENETIC

Polygenetic risk score assessment for breast cancer

Polygenetic risk score

Eligibility Criteria

Age40 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women referred for clinical mammography in the Vestre Viken Breast Centre
  • Breast density BI-RADS a or d
  • y.o.

You may not qualify if:

  • Prior history of breast cancer or premalignant breast disease
  • Prior genetic counselling/testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestre Viken Hospital Trust

Drammen, Norway

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tone Hovda, Phd

    Vestre Viken HT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

February 16, 2023

Study Start

February 1, 2023

Primary Completion

May 1, 2024

Study Completion (Estimated)

November 11, 2035

Last Updated

May 23, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)