Clinical Pilot Study for Personalized Risk-based Breast C... | NCT05731453

Studies
Clinical Pilot Study for Personalized Risk-based Breast Cancer Screening

NCT05731453

Sponsor

Vestre Viken Hospital Trust

Status

Active, not recruiting

Last Update Posted

May 23, 2024Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Polygenetic risk score

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

May 1, 2024Actual

Completion Date

Nov 11, 2035Estimated

First Submitted Date

Jan 10, 2023

First Submission Date that Met QC Criteria

Feb 7, 2023

First Posted Date

Feb 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2024

Last Update Posted Date

May 23, 2024Actual

Name	Class
Oslo University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Polygenetic risk score	Experimental	Assessment of polygenetic risk score for breast cancer	Genetic: Polygenetic risk score

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polygenetic risk score	Genetic	Polygenetic risk score assessment for breast cancer	Polygenetic risk score

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Compliance to individual recommedations for breast cancer screening	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tone Hovda, Phd	Vestre Viken HT	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vestre Viken Hospital Trust		Drammen			Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided