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临床试验/NCT05871593
NCT05871593尚未招募不适用

CIRculating Cell-free nUcLeic Acids in Cancer Therapy Monitoring -01

University Hospital Tuebingen0 个研究点目标入组 200 人开始时间: 2023年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
cfDNA/cfRNA

研究概览

简要总结

In cooperation with the molecular tumor board of the University Hospital Tübingen (UKT), a prospective collection of blood samples during the course of therapy is planned. It is a pilot study in which the technical feasibility of the approach (Highly Sensitive Next-Generation Sequencing (NGS) methods) initially should to be evaluated and further developed.

详细描述

In this study, we would like to use and further develop Highly Sensitive Next-Generation Sequencing (NGS) methods. For this purpose, circulating cell-free nucleic acids (cell free desoxyribonucleic acid (cfDNA) or cell free ribonucleic acid (cfRNA)) are first isolated from the blood plasma. The circulating tumor desoxyribonucleic acid (ctDNA) and circulating tumor ribonucleic acid (ctRNA) fractions contained therein arise from the tumor tissue and can provide information about the existing tumor burden and the original tissue of the tumor. Somatic Single Nucleotide Variants (SNVs) and insertions and deletions (indels) serve as biomarkers within the ctDNA and ctRNA. The ctDNA also contains epigenetic information in the form of DNA methylation, which shows a characteristic pattern for each tissue. Informative regions of the genome can be specifically enriched using personalized or fixed NGS panels. In this way, an ultra-deep sequencing of defined regions can be carried out and even the smallest concentrations of ctDNA and ctRNA in liquid biopsies can be detected.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Advanced tumor disease
  • Ability to consent
  • Existence of a declaration of consent signed by the patient and physician (informed consent for study participation and Comprehensive Cancer Center (CCC) biobank
  • Existence or planned implementation of tumor-normal sequencing (usually carried out in a diagnostic context upon presentation at the Molecular Tumor Board (MTB)

排除标准

  • No therapy recommendation by MTB

结局指标

主要结局

cfDNA/cfRNA

时间窗: Day 3: Tumor recurrence or disease progression

Ratio of cfDNA/cfRNA at recurrence or disease progression

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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