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临床试验/NCT01737255
NCT01737255已完成不适用

Magnetic Resonance Imaging Screening In Li Fraumeni Syndrome: An Exploratory Whole Body MRI Study

Institute of Cancer Research, United Kingdom1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
Diagnosis of malignant disease

研究概览

简要总结

This study is aimed at exploring the use of whole body MRI for early cancer detection in TP53 mutation carriers and population controls, with the hypothesis that more cancers will be detected in the TP53 mutation carrier group. A secondary end-point will be the number of incidental findings detected and subsequent investigations required. A series of questionnaires will be used to assess the psychological impact of screening on both the study and control group.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Carrier of germline TP53 mutation which, in the view of the geneticist, is not known to be low penetrance OR non-related individual with no personal history of malignancy and no first degree relatives diagnosed with malignancy under the age of 50 years
  • Please note, TP53 carrier cohort is complete and no longer open to recruitment
  • Age between 18 and 60
  • Able to give informed consent

排除标准

  • Individual with low penetrance TP53 mutation
  • Individual with TP53 variant of unknown significance.
  • Previous malignancy diagnosed < 5 years ago in TP53 carriers (except non-melanomatous skin cancer or cervical CIS) Previous history of malignancy in non-related controls (except non-melanomatous skin cancer or cervical CIS)
  • Current symptoms suggestive of malignancy
  • Contraindication to MRI (such as non-MR compatible metal implants) as specified by the standard MR safety checklist
  • Claustrophobia
  • ECOG performance status >2

结局指标

主要结局

Diagnosis of malignant disease

时间窗: Within 12 months of MRI scan

Following MRI scan further investigations may be required to diagnose malignancy

次要结局

  • Diagnosis of relevant non-malignant disease(12 months following MRI scan)
  • Diagnosis of non-relevant disease, number and type of investigations required(12 months following MRI)
  • Psychological impact of MRI screening(12 months following MRI screening)

研究者

发起方
Institute of Cancer Research, United Kingdom
申办方类型
Other
责任方
Sponsor

研究点 (1)

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