Personalised Risk-based Breast Cancer Prevention and Screening

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

28389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2020-12-31

Brief Summary

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This is a cohort study, applied research and T3 translational genomics to estimate the impact of genetic risk for breast cancer detection in the screening program. The study group base consists of 28 389 female participants, currently in the age-group 22-79, in the Biobank of Estonian Genome Centre. The study is aimed to demonstrate the usability of personalised approach for adjusting and stratifying screening recommendations, based on predicted genetic risk estimates for breast cancer in the situation, where the genome data could be available from all women who have given informed consent for that. The project includes both the detection of moderate and high hereditary breast cancer risk carriers as well as high risk polygenic risk-score (consisting several single nucleotide polymorphisms) carriers among healthy individuals for application of personalised prevention and screening strategies.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Cohort 1

High monogenic breast cancer risk

Group Type ACTIVE_COMPARATOR

Mammography outside official screening

Intervention Type DIAGNOSTIC_TEST

Radiologic study

Cohort 2

High polygenic breast cancer risk

Group Type ACTIVE_COMPARATOR

Mammography outside official screening

Intervention Type DIAGNOSTIC_TEST

Radiologic study

Cohort StMG

Standard mammography screening in age 50-69

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mammography outside official screening

Radiologic study

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Cohort 1:

* Available NGS (WGS or WES) data for detection of breast cancer moderate to high genetic risk variants in BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, CHEK2, NBN, NF1 genes;
* Available genetic (WGS, genotyping) data for PRS calculation, participants in age 40-74 will be further selected;

Cohort 2:

* Available genotyping data;
* No available NGS data for BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, ATM, PALB2, CHEK2, NBN, NF1 genes;
* Participants in the age group 40-74 with available genetic data for PRS calculation;

Cohort StMG:

• Female participants in Estonian Biobank in the age group 50-69 participating at least once in the current Estonian population-based screening program during 2016-2020.