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

Genetic Predisposition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04920513
• Other study ID #: 21 KHCC 27
• Status: Active, not recruiting
• Start date: May 1, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: King Hussein Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genetic Predisposition
• Genetic Predisposition to Disease

Locations

Country	Name	City	State
Jordan	King Hussein Cancer Center	Amman

Sponsors (1)

Lead Sponsor	Collaborator
King Hussein Cancer Center

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed cancer patients tested by universal multigene panel testing		2021-2023
Primary	Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing		2021-2023
Primary	To determine the reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients.		2021-2023
Secondary	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	2021-2023
Secondary	Prevalence of pathogenic or likely pathogenic mutations among tested family members of the participants with pathogenic mutations using the universal multigene panel		2021-2023
Secondary	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
Secondary	To determine the reasons/ Barriers for refusal of genetic cascade testing among family members of tested patients with pathogenic mutation		2021-2023