Universal- Versus Guidelines-Directed Genetic Testing for Germline Pathogenic Variants Utilizing a Multi-Gene Panel for Inherited Cancers in Non-Western Society.

N/ACompletedNCT04920513

King Hussein Cancer Center3,000 enrolled

Overview

The investigators aim to study the pattern and frequency of pathogenic variants among ALL newly diagnosed cancer patients in a genetically distinct population. Additionally, the investigators will study the uptake rate of "cascade family screening", frequency of pathogenic variants and barriers against testing.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Genetic Predisposition

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 cancer; any site, any stage (prior history of cancer is allowed) * Jordanian nationality * Willingness to participate * Signed consent form Exclusion Criteria: * Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications) * Non-Jordanian * Patients with Leukemia, Lymphoma and Myeloma

Locations (1)

King Hussein Cancer Center

Amman, Amman Governorate, Jordan

Outcomes

Primary Outcomes

Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed cancer patients tested by universal multigene panel testing

Time frame: 2021-2023

Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing

Time frame: 2021-2023

To determine the reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients.

Time frame: 2021-2023

Secondary Outcomes

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

The family of tested patients with pathogenic mutations will be offered the genetic testing

Time frame: 2021-2023

Prevalence of pathogenic or likely pathogenic mutations among tested family members of the participants 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

To determine the reasons/ Barriers for refusal of genetic cascade testing among family members of tested patients with pathogenic mutation

Time frame: 2021-2023

Data from ClinicalTrials.gov

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