Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients With Breast Cancer

N/ACompletedNCT04920656

King Hussein Cancer Center1,000 enrolled

Overview

The study aims to examinethe pattern and frequency of pathogenic variants among all newly diagnosed breast cancer patients in a genetically distinct population. Additionally, the uptake rate of "cascade family screening" , frequency of pathogenic variants and barriers against testing will be studied.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Breast Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patient, age ≥ 18 years at time of cancer diagnosis * Pathology proven diagnosis of breast cancer (including DCIS); any stage. (prior history of cancer is allowed) * Willingness to participate * Signed consent form. Exclusion Criteria: \- Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications

Locations (1)

King Hussein Cancer Center

Amman, Amman Governorate, Jordan

Outcomes

Primary Outcomes

Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed breast cancer patients tested by universal multigene panel testing or guideline-based targeted testing

Time frame: 2021-2023

Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing versus guideline-based targeted testing

Time frame: 2021-2023

The reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients

Time frame: 2021-2023

Secondary Outcomes

Rate of cascade testing of family members of the participants with positive pathogenic mutation

The family of the positive patients will be offered the genetic testing.

Time frame: 2021-2023

Prevalence of pathogenic or likely pathogenic mutations among family members of the patients with pathogenic mutations using the universal multigene panel

Time frame: 2021-2023

Prevalence of variants of uncertain significance (VUS) among tested family members of participants with pathogenic mutations as assessed by universal multigene panel testing

Time frame: 2021-2023

The reasons/ Barriers for refusal of genetic cascade testing among family members of the tested patients with pathogenic mutations

Time frame: 2021-2023

Data from ClinicalTrials.gov

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