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

Sponsor
King Hussein Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04920513
Collaborator
(none)
3,000
Enrollment
1
Location
24
Anticipated Duration (Months)
125.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    Universal- Versus Guidelines-Directed Genetic Testing for Germline Pathogenic Variants Utilizing a Multi-Gene Panel for Inherited Cancers in Non-Western Society.
    Actual Study Start Date :
    May 1, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed cancer patients tested by universal multigene panel testing [2021-2023]

    2. Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing [2021-2023]

    3. To determine the reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients. [2021-2023]

    Secondary Outcome Measures

    1. 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

    2. Prevalence of pathogenic or likely pathogenic mutations among tested family members of the participants with pathogenic mutations using the universal multigene panel [2021-2023]

    3. 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]

    4. To determine the reasons/ Barriers for refusal of genetic cascade testing among family members of tested patients with pathogenic mutation [2021-2023]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 King Hussein Cancer Center Amman Jordan 11941

    Sponsors and Collaborators

    • King Hussein Cancer Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hikmat Abdel-Razeq, Professor, Chairman of department of medicine, Chief Medical officer, Deputy Director General, King Hussein Cancer Center
    ClinicalTrials.gov Identifier:
    NCT04920513
    Other Study ID Numbers:
    • 21 KHCC 27
    First Posted:
    Jun 10, 2021
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hikmat Abdel-Razeq, Professor, Chairman of department of medicine, Chief Medical officer, Deputy Director General, King Hussein Cancer Center
    Genetics
    Additional relevant MeSH terms:
    Disease Susceptibility
    Genetic Predisposition to Disease

    Study Results

    No Results Posted as of Aug 18, 2022