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

Completed

• Conditions: Genetic Predisposition

• Registration Number: NCT04920513
• Lead Sponsor: King Hussein Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-05-16
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-10
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing	2021-2023
To determine the reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients.	2021-2023
Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed cancer patients tested by universal multigene panel testing	2021-2023

Secondary Outcome Measures

Name	Time	Method
Rate of cascade of family member testing of the participants with positive pathogenic mutation	2021-2023	The family of tested patients with pathogenic mutations will be offered the genetic testing
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

Trial Locations

Locations (1)

King Hussein Cancer Center; 🇯🇴 Amman, Jordan