跳至主要内容
临床试验/NCT06714227
NCT06714227已完成不适用

Genetics of Prostate Cancer in Young Patients

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Presence/absence and type of pathogenic/probably pathogenic germline variants in genes previously implicated in prostate cancer etiology

研究概览

简要总结

The aim of the study is to identify genetic variants in genes responsible or potentially responsible for the etiology of prostate cancer in a population of patients with early onset of the malignancy.

详细描述

The data collected from the study will provide a preliminary picture of the prevalence and type of germline pathological variants in the context of early-onset prostate cancer in the Italian population. In addition, alterations in DNA repair genes other than BRCA1-2 and ATM, including any genes yet undescribed as causative or predisposing, have yet to be explored in detail: in many cases the significance of variants is not well defined in terms of pathogenicity, prognostic value, and predictive indicator of response to different treatments. Therefore, an extensive mutational analysis-even if performed on a limited number of patients-can generate a large number of variants for evaluation, bringing knowledge about the relationship between these variants and the onset of malignancy The information obtained, although merely exploratory, may indicate the desirability of conducting systematic genetic investigations in this particular patient population in the future, especially in view of the new therapeutic strategies available such as immunotherapy or PARP inhibitors

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients with histologic or cytologic diagnosis of prostate cancer
  • Age ≥18 years and ≤55 years at first diagnosis of prostate carcinoma
  • Availability of clinical and instrumental data related to prostate cancer
  • Patients who knowingly express willingness to participate in the study after signing written informed consent

排除标准

  • 未提供

结局指标

主要结局

Presence/absence and type of pathogenic/probably pathogenic germline variants in genes previously implicated in prostate cancer etiology

时间窗: 4 years

molecular analysis of genomic DNA

次要结局

  • Presence/absence and type of variants in genes potentially implicated in the etiology of prostate cancer (candidate genes).(4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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