跳至主要内容
临床试验/NCT03832062
NCT03832062招募中不适用

Value of Analysing Under-utilised Leftover Tissue (VauLT)

Royal Marsden NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2018年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
1
主要终点
The percentage of cases from surgical lists with tumour remains greater than 1g across 8 tumour groups

研究概览

简要总结

Intratumour heterogeneity is well recognized in multiple cancer types and ultimately leads to therapeutic resistance. It also limits the ability of small samples to represent the whole tumour, having implications for diagnosis, molecular analysis and understanding of the tumour immune microenvironment. By blending- 'homogenizing'- leftover tumour tissue in excess of that required for diagnosistic purposes, one may create a more representative sample for analysis.

详细描述

In order to establish the feasibility of homogenization as a potential companion diagnostic tool, our study aims to 1) evaluate how many surgical cases have left over tissue amenable to homogenization and 2) pilot homogenization across multiple tumour types. The molecular profile of the homogenate will be compared to that obtained from the diagnostic specimen using next generation sequencing techniques.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

  • Leftover formalin-fixed tissue (ie that would be otherwise discarded by histopathology) from cancer surgery.
  • Tissues for Research consent has been provided.
  • Patient age >18yo.
  • Minimum of 1 gram of residual tumour remaining in leftover surgical tissue
  • Minimum of 1 gram of normal tissue present.

排除标准

  • Advanced Practitioner in histological dissection deems tumour sample to be inadequate.
  • Leftover surgical tumour tissue greater than 20kg.

结局指标

主要结局

The percentage of cases from surgical lists with tumour remains greater than 1g across 8 tumour groups

时间窗: 24 Months

Surgical lists will be generated providing cases of all surgeries containing excess tumour tissue. The tissue will be dissected and weighed to determine if tumour tissue available is greater than 1g

次要结局

  • Median time (in minutes) required for the blending (actual homogenization) of each tissue type(24 Months)
  • Median time (in minutes) required for dissection of the leftover surgical tissue into tumour, tumour-adjacent and normal tissue(24 Months)
  • Difference in molecular profile between the diagnostic block and the homogenized sample. This will be measured by next generation sequencing techniques across the 8 primary tumour types(24 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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