Universal- Versus Guidelines-Directed Genetic Testing for Germline Pathogenic Variants Utilizing a Multi-Gene Panel for Inherited Cancers in Non-Western Society.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications)
- •Non-Jordanian
- •Patients with Leukemia, Lymphoma and Myeloma
结局指标
主要结局
Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing
时间窗: 2021-2023
To determine the reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients.
时间窗: 2021-2023
Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed cancer patients tested by universal multigene panel testing
时间窗: 2021-2023
次要结局
- Rate of cascade of family member testing of the participants with positive pathogenic mutation(2021-2023)
- To determine the reasons/ Barriers for refusal of genetic cascade testing among family members of tested patients with pathogenic mutation(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)
- Prevalence of pathogenic or likely pathogenic mutations among tested family members of the participants with pathogenic mutations using the universal multigene panel(2021-2023)
研究者
Hikmat Abdel-Razeq
Professor, Chairman of department of medicine, Chief Medical officer, Deputy Director General
King Hussein Cancer Center