Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients With Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04920656
• Other study ID #: 20 KHCC 202
• Status: Active, not recruiting
• Start date: April 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 study aims to examinethe pattern and frequency of pathogenic variants among all newly diagnosed breast cancer patients in a genetically distinct population. Additionally, the uptake rate of "cascade family screening" , frequency of pathogenic variants and barriers against testing will be studied.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• 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 breast cancer (including DCIS); any stage. (prior history of cancer is allowed)
• Willingness to participate
• Signed consent form.

Exclusion Criteria:

• Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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 breast cancer patients tested by universal multigene panel testing or guideline-based targeted testing		2021-2023
Primary	Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing versus guideline-based targeted testing		2021-2023
Primary	The reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients		2021-2023
Secondary	Rate of cascade testing of family members of the participants with positive pathogenic mutation	The family of the positive patients will be offered the genetic testing.	2021-2023
Secondary	Prevalence of pathogenic or likely pathogenic mutations among family members of the patients 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	The reasons/ Barriers for refusal of genetic cascade testing among family members of the tested patients with pathogenic mutations		2021-2023