跳至主要内容
临床试验/NCT06889883
NCT06889883招募中不适用

Development and Validation of a Blood Test for Early Diagnosis of Colorectal Cancer Based on Molecular Markers and Risk Factors Identified With Artificial Intelligence Tools

ADVANCED MARKER DISCOVERY S.L.9 个研究点 分布在 1 个国家目标入组 510 人开始时间: 2023年6月6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
510
试验地点
9
主要终点
Clinical Validation

研究概览

简要总结

This is a prospective, multicenter, case-control study. The aim is to develop an optimized algorithm by combining the levels of molecular markers in plasma together with risk factors for developing colorectal cancer and clinical data of patients diagnosed with CRC or AA and healthy individuals.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients over the age of 18 who are able to understand the participant information and sign the informed consent.
  • •Patients who are going to undergo colonoscopy or surgical resection for tumor (CRC).

排除标准

  • •Patients who had developed any type of cancer in the 5 years prior to their participation in this study.
  • •Patients who have received previous chemotherapy or radiotherapy.
  • •Patients diagnosed with non-advanced adenomas, serrated polyps, Familial Adenomatous Polyposis or Lynch Syndrome.
  • •Patients with inadequate bowel preparation for colonoscopy.
  • •Patients who have undergone colonoscopy/polipectomy in the previous 5 years.
  • •Patients with hemolyzed plasma.

结局指标

主要结局

Clinical Validation

时间窗: 36 months

To clinically validate the diagnostic capability of the algorithm for early detection of CRC and AA that combines molecular markers and risk factors

次要结局

未报告次要终点

研究者

发起方
ADVANCED MARKER DISCOVERY S.L.
申办方类型
Industry
责任方
Sponsor

研究点 (9)

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