跳至主要内容
临床试验/NCT06253338
NCT06253338招募中不适用

Optimization of Radiation Protection Through Genomic Analyses in the Analysis of Changes in Cells of the Hematopoietic System Before and During High Dose External Beam Radiotherapy

University Hospital, Essen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月1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
30
试验地点
2
主要终点
Alteration of the genome under radiotherapy

研究概览

简要总结

The long-term goal is to define "signatures" in the form of genomic changes through sequence analyses of genomic DNA using modern Next Generation Sequencing (NGS) methods, which

  1. determine the radiation exposure of humans.
  2. provide information about the exposure (dose).
  3. determine the radiation quality.
  4. predict the repair capacity and radiation resistance of an individual.

详细描述

The planned research work will investigate structural changes in DNA caused by loosely ionizing and high-LET (Linear Energy Transfer) radiation as well as their attribution to double-strand break repair pathways, which will be analysed in parallel using modern microscopy methods. Our aim is to incorporate sequencing technologies into the spectrum of methods used in radiation research and radiation protection. It is important for us to consider the practical requirements of radiation protection and to extend our experimental approaches to cell types relevant to radiation protection. For this reason, we have now created a separate work program that will focus specifically on sequence analyses in irradiated human lymphocytes. The aim is to successfully transfer the experimental approaches and bioinformatic analyses established in previous experiments in human skin fibroblasts to lymphocytes. Subjects can donate blood samples on a voluntary basis at predetermined times. Only subjects without previous radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc. and without a previous tumor diagnosis in the medical history and in good performance status (ECOG 0-1) will be included.

研究设计

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

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

  • ECOG 0/1 no prior treatment no prior cancer diagnosis thoracic or head and neck cancer

排除标准

  • prior treatment (chemotherapy, radiotherapy, etc.) prior cancer diagnosis

结局指标

主要结局

Alteration of the genome under radiotherapy

时间窗: 5 years

Radiotherapy of patients, quantitative tissue sampling, cell culture survival rate and mitotic index after predifined radiation treatment, Incidence of the sample and percentage

次要结局

  • Progression Free Survival(5 years)
  • Overall Survival(5 years)
  • Radiation induced changes in the genome(2 months to 5 years)

研究者

发起方
University Hospital, Essen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maja Guberina

PD Dr. med. (MD) / specialist forradiation oncology, senior consultant

University Hospital, Essen

研究点 (2)

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