Psychosocial impact of incorporating the 313-SNP-based Polygenic Risk Score in breast cancer risk prediction for women from non-BRCA1/2 breast cancer families

Psychosocial impact of incorporating the 313-SNP-based Polygenic Risk Score in breast cancer risk prediction for women from non-BRCA1/2 breast cancer families - Individualised breast cancer risk prediction

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49416

Enrollment

100

Registered

2019-05-13

Start date

2019-08-22

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Women with an age between 35 and 60 years old - European ancestry - Not affected with breast cancer or other type of cancer - First degree relative with breast cancer - Access to the internet - Ability to answer a Dutch questionnaire Further family history should comply with one of the referral criteria for the Clinical Geneticist below. This is from the perspective of the affected counselee, who invites her unaffected relatives. - Breast cancer before the age of 40 - Two primary breast tumours with the first diagnosis before the age of 50 - Triple negative (Estrogen and Progesterone receptor negative, Her2Neu negative) breast cancer before the age of 60 - Two first degree female relatives with breast cancer below the age of 50 - Three first or second degree female relatives with breast cancer, at least one below the age of 50

Exclusion criteria

Exclusion criteria: - The family does not fulfil referral criteria for the Clinical Geneticist - A (likely) pathogenic BRCA1, BRCA2, PALB2, ATM or CHEK2 variant is detected in the affected counselee - The participant is affected with cancer - Individuals with mental retardation or otherwise unable to understand the informed consent procedure

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the difference in the scores of the Distress thermometer and Psychosocial Aspects of Hereditary Cancer (PAHC) questionnaire before and after the web consult, where the individualised risk score will be communicated, to measure the psychosocial impact.	—

Secondary

Measure	Time frame
Secondary, the precision risk assessment and its potential to change clinical management relative to current risk assessment practice.	—

Countries

Netherlands

Outcome results