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OpenTrials
Completed

NCT Number: NCT04920656

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King Hussein Cancer Center

Amman, Amman Governorate, 11941, Jordan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 2021-2023

  2. Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing versus guideline-based targeted testing

    Time frame: 2021-2023

  3. The reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients

    Time frame: 2021-2023

Secondary outcomes

  1. Rate of cascade testing of family members of the participants with positive pathogenic mutation

    Time frame: 2021-2023

    The family of the positive patients will be offered the genetic testing.

  2. Prevalence of pathogenic or likely pathogenic mutations among family members of the patients with pathogenic mutations using the universal multigene panel

    Time frame: 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

    Time frame: 2021-2023

  4. The reasons/ Barriers for refusal of genetic cascade testing among family members of the tested patients with pathogenic mutations

    Time frame: 2021-2023

Sponsors and collaborators

Lead sponsor

King Hussein Cancer Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2021
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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