跳至主要内容
临床试验/NCT05724992
NCT05724992招募中不适用

Standardised Genetic Profiling of Subjects Belonging to the Italian Multicenter Registry of Prospective Surveillance of Subjects at Genetic Risk of Pancreatic Cancer

Associazione Italiana per lo Studio del Pancreas2 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2022年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
2
主要终点
Presence - absence of predisposing mutations

研究概览

简要总结

The goal of the PROPH-ITA Study is to perform genetic testing in family members of pancreatic cancer patients who may have a genetic predisposition. The subjects belong to the Italian Registry of Families At Risk of Pancreatic Cancer (IRFARPC, #NCT04095195). This investigational study will assess the genetic background of subjects with familiarity with pancreatic cancer only.

Participants may accept to undergo genetic testing as part of the IRFARPC registry, through a saliva-swab-based 41-gene panel test.

Up to 3,000 participants will be enrolled in this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being enrolled on the IRFARPC registry
  • Having familiarity for pancreatic cancer (according to the IRFARPC criteria, Capurso et al. Dig Liv Dis, 2020)
  • Willingness to participate in saliva-swab-based genetic testing

排除标准

  • Already known genetic mutation

结局指标

主要结局

Presence - absence of predisposing mutations

时间窗: 5 years

Prevalence of genetic mutations over the total tested

次要结局

  • Correlation of genetic mutations with familial oncological history(5 years)
  • Correlation of genetic mutations with personal oncological history(5 years)

研究者

发起方
Associazione Italiana per lo Studio del Pancreas
申办方类型
Other
责任方
Sponsor

研究点 (2)

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