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

NCT04920513 | Completed

• 1 other identifier: 21 KHCC 27
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Genetic Predisposition

Keywords

Genetics

Outcome Measures

Primary Outcomes (3)

• 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

• To determine the reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients.

  2021-2023

Secondary Outcomes (4)

• Rate of cascade of family member testing of the participants with positive 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

• To determine the reasons/ Barriers for refusal of genetic cascade testing among family members of tested patients with pathogenic mutation

  2021-2023

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients who fulfill the inclusion/exclusion criteria and are diagnosedat KHCC will be invited. A total of 3000 patients are estimated to participate

You may qualify if:

• 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

You may not qualify if:

• Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications)
• Non-Jordanian
• Patients with Leukemia, Lymphoma and Myeloma

Sponsors & Collaborators

• King Hussein Cancer Center: lead

Study Sites (1)

King Hussein Cancer Center

Amman, Amman Governorate, 11941, Jordan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood sample

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hikmat Abdel-Razeq

  King Hussein Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chairman of department of medicine, Chief Medical officer, Deputy Director General

Study Record Dates

• First Submitted: May 16, 2021
• First Posted: June 10, 2021
• Study Start: May 1, 2021
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

JO (1)