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

March 18, 2024 updated by: Hikmat Abdel-Razeq, King Hussein Cancer Center

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Jordan
      • Amman, Jordan, 11941
        • King Hussein Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of variants of uncertain significance (VUS) among tested family members of participants with pathogenic mutations as assessed by universal multigene panel testing
Time Frame: 2021-2023
2021-2023
Rate of cascade of family member testing of the participants with positive pathogenic mutation
Time Frame: 2021-2023
The family of tested patients with pathogenic mutations will be offered the genetic 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
Time Frame: 2021-2023
2021-2023
To determine the reasons/ Barriers for refusal of genetic cascade testing among family members of tested patients with pathogenic mutation
Time Frame: 2021-2023
2021-2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Hussein Cancer Center

Investigators

  • Principal Investigator: Hikmat Abdel-Razeq, King Hussein Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 16, 2021

First Submitted That Met QC Criteria

June 3, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21 KHCC 27

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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