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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04920513

Enrollment

3000

Registered

2021-06-10

Start date

2021-05-01

Completion date

2025-02-01

Last updated

2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Predisposition

Keywords

Genetics

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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
Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing	2021-2023

Secondary

Measure	Time frame	Description
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 pathogenic or likely pathogenic mutations among tested family members of the participants with pathogenic mutations using the universal multigene panel	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	—

Countries

Jordan

Outcome results