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临床试验/NCT05423886
NCT05423886尚未招募不适用

The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration

Esther Toes-Zoutendijk2 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2022年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20,000
试验地点
2
主要终点
Detection rate of colorectal cancer and advanced adenomas

研究概览

简要总结

We aim to improve the yield and effectiveness of the Dutch colorectal cancer screening program by using a personalized screening strategy based on fecal Hemoglobin concentration in previous screening round for participants with a negative fecal immunochemical test (FIT).

详细描述

A fecal Hemoglobin concentration just below the cut-off of the fecal immunochemical test (FIT) is associated with a higher risk for the detection of colorectal cancer of advanced adenomas at consecutive screenings. Individuals with these higher fecal Hemoglobin concentrations may benefit from shorter screenings interval, whereas individuals without any fecal Hemoglobin concentrations could benefit from longer screening intervals.

A randomized controlled trial will be conducted within the national CRC screening program among individuals with a negative FIT in the previous screening round. Individuals in the intervention arm will receive an invitation after 1, 2, or 3 years depending on their fecal Hemoglobin concentration in the previous round, whereas individuals in the control arm will receive an invitation after 2 years according to current practice.

The overall aim of this study is to improve the balance between harms and benefits of CRC screening, by using a personalized approach based on fecal Hemoglobin concentration at previous screening. More specifically, this study has three goals:

  1. Evaluate the superiority of risk-based FIT screening in a randomized controlled study embedded in a running national screening program;
  2. Evaluate the feasibility and acceptability of risk-based FIT screening in a national screening program;
  3. Estimate the long-term effect of personalized screening versus uniform screening.

To achieve these goals a randomized controlled trial, focus groups and microsimulation modelling will be conducted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
56 Years 至 71 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previous negative FIT (below the cut-off of 47 microgram per gram feces)

排除标准

  • Previously tested with FIT cut-off of 15 microgram per gram feces

结局指标

主要结局

Detection rate of colorectal cancer and advanced adenomas

时间窗: 6 months after the last invitation

Number of colorectal cancers and advanced adenomas per screened individual

次要结局

  • Acceptability(6 months after the last invitation)

研究者

发起方
Esther Toes-Zoutendijk
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Esther Toes-Zoutendijk

Dr.

Erasmus Medical Center

研究点 (2)

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