Effect of Polygenic Risk Modification on breast cancer risk management and prevention in unaffected women from genetically predisposed families: The PRiMo Trial

Peter MacCallum Cancer Centre0 个研究点目标入组 2,400 人开始时间: 2021年1月8日最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Prospective Enrolment:
•(1) Undergoing a predictive test for a likely pathogenic (Class 4) or pathogenic (Class 5) familial mutation in a gene associated with increased risk of breast cancer - BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51C, RAD51D at a participating Familial Cancer Clinic.
•Retrospective Enrolment:
•(1) Have previously completed germline testing and been found to harbour a likely pathogenic (Class 4) or pathogenic (Class 5) variant in a breast/ovarian cancer associated ‘moderate risk’ gene: PALB2, CHEK2, ATM, RAD51C, RAD51D at a participating Familial Cancer Clinic.
•Prospective and Retrospective enrolment
•(2) Female, unaffected by invasive or in-situ breast cancer or epithelial ovarian cancer
•(3) Aged 18 years or above and < 80 years
•(4) Have access to the internet and a computer, tablet or smart phone and a basic level of familiarity with digital platforms.

•(1) Unable to read and understand patient study information, including an English language patient information and consent form
•(2) Have previously undertaken genomic testing that included polygenic risk information for breast or ovarian cancer
•(3) Undergoing current treatment for a cancer diagnosis.
•(4) No DNA sample at a participating diagnostic laboratory
•(5) Known at time of enrolment to have or be at risk for a significant risk-factor for breast or ovarian cancer that is not captured in the PRiMo risk assessment. For example, a diagnosis of Li-Fraumeni syndrome or predictive testing for a variant with an atypical risk in a known gene (hypomorphs).

发起方

Peter MacCallum Cancer Centre