The Identification of Men With a Genteic Predisposition to Prostate Cancer: Targeted Screening in Men at Higer Genetic Risk and Controls Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Prostate Cancer Diagnosis (Telephone Follow-up Interview)
研究概览
简要总结
This interventional study is a follow-up component of the IMPACT project, which aims to identify men at increased hereditary risk of prostate cancer. The study focuses on men carrying BRCA1 and BRCA2 germline mutations and a control group of non-carriers. Participants are contacted by telephone to determine whether they developed prostate cancer during 2025 and to collect updated personal and family medical history information. The goal of the study is to support targeted prostate cancer screening programs in men at higher genetic risk.
详细描述
Prostate cancer is one of the most common malignancies in men. Individuals carrying germline mutations in BRCA1 and BRCA2 genes are at increased risk of developing prostate cancer and may benefit from targeted screening strategies. The IMPACT study was designed to evaluate early detection approaches in men with hereditary predisposition to prostate cancer.
This study represents a follow-up assessment within the IMPACT framework. Men with BRCA1 or BRCA2 mutations and a control group of non-carriers are contacted by telephone to collect updated information on prostate cancer diagnosis and other relevant changes in personal and family medical history during the year 2025.
The collected information will contribute to evaluation of prostate cancer incidence in genetically predisposed individuals and may support the development and optimization of targeted prostate cancer screening programs for high-risk populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
2
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants aged 18 years or older
- •BRCA1 or BRCA2 mutation carriers or non-carrier controls enrolled in the IMPACT study
- •Eligible for targeted prostate cancer screening and follow-up
- •Ability to participate in telephone follow-up interview
- •Written informed consent provided
排除标准
- •History of prostate cancer prior to enrollment
- •Inability to provide informed consent or complete follow-up procedures
- •Any condition that, in the investigator's opinion, would interfere with study participation or data quality
研究组 & 干预措施
BRCA1/BRCA2 Mutation Carriers
Men carrying a BRCA1 or BRCA2 germline mutation enrolled in the IMPACT targeted prostate cancer screening study and followed up with telephone interview for updated medical and family history, including prostate cancer diagnosis.
干预措施: Targeted Prostate Cancer Screening (Other)
Control Group (Non-Carriers)
Men without BRCA1/BRCA2 mutations enrolled as controls in the IMPACT targeted prostate cancer screening study and followed up with telephone interview for updated medical and family history, including prostate cancer diagnosis.
干预措施: Telephone Follow-Up Interview (Other)
结局指标
主要结局
Prostate Cancer Diagnosis (Telephone Follow-up Interview)
时间窗: Once during follow-up (up to 12 months)
Prostate cancer diagnosis will be assessed by telephone follow-up interview and review of available medical history. Participants will be asked whether they have been diagnosed with prostate cancer since the last study contact. Updated personal and family medical history will also be collected.
次要结局
未报告次要终点