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临床试验/NCT06035471
NCT06035471尚未招募不适用

Can we Use a Simple Blood Test to Reduce Unnecessary Adverse Effects From Radiotherapy by Timely Identification of Radiotherapy-resistant Rectal Cancers? MeD-Seq Rectal Study

Erasmus Medical Center0 个研究点目标入组 75 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
75
主要终点
cfDNA methylation markers

研究概览

简要总结

Chemoradiation therapy (CRT) followed by surgery is currently the standard of care to treat patients with locally advanced rectal cancer (LARC). CRT reduces local recurrences, but is associated with significant damage to the surrounding healthy tissue that can severely impact quality of life. Additionally, a proportion of patients (hardly) benefit from CRT. We aim to develop a diagnostic innovation, which can enable a more selective and thereby more effective use of the available therapies for rectal cancer patients.

The objective of this study is to investigate whether patients can be identified who will response to CRT prior to start of the CRT in rectal cancer and therefore avoid possible severe side effects in patients who will not reponse on CRT.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Age ≥18 years
  • Histologically confirmed rectal adenocarcinoma
  • Scheduled for neoadjuvant chemoradiation
  • Written informed consent.

排除标准

  • Scheduled to another neoadjuvant schedule that comprises systemic chemotherapy or short-course radiation
  • Not able to read or understand Dutch language or mentally not capable.

结局指标

主要结局

cfDNA methylation markers

时间窗: 4 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

C. Verhoef

Professor

Erasmus Medical Center

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