Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

NCT ID: NCT05731453

Last Updated: 2024-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2035-11-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Polygenetic risk score

Assessment of polygenetic risk score for breast cancer

Group Type EXPERIMENTAL

Polygenetic risk score

Intervention Type GENETIC

Polygenetic risk score assessment for breast cancer

Interventions

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Polygenetic risk score

Polygenetic risk score assessment for breast cancer

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tone Hovda, Phd

Role: PRINCIPAL_INVESTIGATOR

Vestre Viken HT

Locations

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Vestre Viken Hospital Trust

Drammen, , Norway

Site Status

Countries

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Norway

Other Identifiers

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494936

Identifier Type: -

Identifier Source: org_study_id

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