Universal- Versus Guidelines-Directed Genetic Testing for Germline Pathogenic Variants Utilizing a Multi-Gene Panel for Inherited Cancers in Non-Western Society.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Genetic Predisposition
- Sponsor
- King Hussein Cancer Center
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Hikmat Abdel-Razeq
Professor, Chairman of department of medicine, Chief Medical officer, Deputy Director General
King Hussein Cancer Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed cancer patients tested by universal multigene panel testing
Time Frame: 2021-2023
Secondary Outcomes
- Rate of cascade of family member testing of the participants with positive pathogenic mutation(2021-2023)
- To determine the reasons/ Barriers for refusal of genetic cascade testing among family members of tested patients with pathogenic mutation(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(2021-2023)
- Prevalence of pathogenic or likely pathogenic mutations among tested family members of the participants with pathogenic mutations using the universal multigene panel(2021-2023)