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临床试验/NCT05385081
NCT05385081Unknown不适用

PREcision Medicine in Cancer in Odense, Denmark (PRECODE) Feasibility of Genomic Profiling and Frequency of Genomic Matched Treatment in Solid Tumors With no Treatment Options

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
900
试验地点
2
主要终点
Turn around time genomic profiling

研究概览

简要总结

The traditional approach to cancer treatment has changes from using drugs approved for the specific cancer diagnosis to a tumor agnostic approach when treating solid tumors. How often will tumor biopsy and genomic profiling in patients with advanced solid tumors with no further evidence based treatment options result in biomarker-driven targeted treatment ? Feasibility of the investigation of patients and median turnaround time from biopsy to available genomic profile is evaluated.

详细描述

Genomic profiling in patients with advanced solid tumors and no further evidence based treatment options is a newer approach. The frequency of genomic alterations varies between individual tumor types and the actionability of somatic variants are different but evolves in line with the development of new targeted drugs. In accordance with expected short survival short assessment time is important to minimize the risk of patient detoriation during the investigation. A fresh biopsy from lesions in progression is preferred for analysis. To minimize the duration of the genomic profiling a genpanel analysis covering the most frequent oncogene targets is preferred.

The primary objective is to evaluate the feasibility of the investigational procedures. The secondary objective is to investigate how often genomic changes in tumor tissue gives rise to a targeted treatment offer and to evaluate the clinical benefit using the Growth Modulation Index.

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

  • Written informed consent
  • Age ≥ 18 years
  • Diagnosis of advanced solid tumors
  • Evidence based treatment options are exhausted
  • Performance Status 0-2
  • Adequate organ function
  • Life expectancy of at least 3 months

排除标准

  • inclusions criteria not met

结局指标

主要结局

Turn around time genomic profiling

时间窗: through study completion, an average of 2 year

Time from date of biopsi to date of available genomic profile discussed at tumor board meeting

次要结局

  • Frequenc of matched treatment offer(through study completion, an average of 2 year)

研究者

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

Karin Holmskov Hansen

MD, Principal Investigator

Odense University Hospital

研究点 (2)

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