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临床试验/NCT05520840
NCT05520840已完成不适用

Evaluation of Peripheral Blood Protein Biomarkers for Colorectal Cancer Screening

University Hospital, Rouen3 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2022年12月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
350
试验地点
3
主要终点
Number of patient with advanced neoplasia at colonoscopy

研究概览

简要总结

The aim of the study is to validate the value of value of peripheral blood protein biomarkers in colorectal cancer screening, and to identify new ones

研究设计

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

入排标准

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

入选标准

  • Patient aged 50 years or older referred for screening colonoscopy after a positive FIT test or for endoscopic resection of a previously identified suspicious colorectal lesion

排除标准

  • Very high risk of colorectal cancer: Lynch syndrome, Familial adenomatous polyposis, Peutz-Jeghers syndrome, Familial polyposis associated with a MutYH gene defect
  • Other solid cancers or haematological malignancies that are progressive and/or undergoing treatment (apart from basal cell skin carcinoma)
  • Contraindication to total colonoscopy

研究组 & 干预措施

Patient referred for screening colonoscopy or for endoscopic resection

Experimental

Patient aged 50 years or older referred for screening colonoscopy after a positive fecal immunochemical test or for endoscopic resection of a previously identified suspicious colorectal lesion will have a blood sampling for biomarkers detection

干预措施: blood sampling for screening of biomarkers (Diagnostic Test)

结局指标

主要结局

Number of patient with advanced neoplasia at colonoscopy

时间窗: Day 1

Number of patient with presence of best isolated serum biomarkers selected from different candidates

时间窗: Day 1

次要结局

  • Number of patient with presence of other isolated serum biomarkers selected from different candidates(Day 1)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (3)

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