跳至主要内容
临床试验/NCT06646341
NCT06646341招募中不适用

EMVI as a Determinant of Metastasis in Colorectal Cancer

Imperial College London1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月1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
100
试验地点
1
主要终点
Comparison of proportion of subjects where Extramural Venous Invasion (EMVI) and tumour deposits vs lymph nodes are associated with distant metastases

研究概览

简要总结

Bowel cancer is the fourth most commonly occurring cancer and the second highest cause of cancer deaths in the UK. Despite advances in treatment, over 40% of patients will die within 5 years. This is normally due to spread of the cancer to other organs (called metastases). Much of the current research focuses on use of additional treatments such as radiotherapy and chemotherapy before or after surgery (adjuvant treatment). It is of vital importance that patients who would benefit from adjuvant treatment can be accurately identified. At the moment, the system used locally to do this places emphasis on the presence of affected lymph nodes (glands). This is because doctors believe that cancer spreads to other organs through the lymphatic system. However, recent studies have suggested that this is not the case.

It is believed that cancer spreads to other organs through the blood stream rather than the lymph node system. This research will look at the genetic material in tumours and metastases as well as in areas of blood vessel invasion and lymph nodes. The analysis will allow us to build a 'family tree' of the tumour and allow us to map the pathway by which the tumour spreads. Tissue samples already collected through a patient's routine care will be used for this study. If the spread through the blood vessels is proven, this would change the way in which patients are selected for treatment and allow development of new treatments to target these pathways.

详细描述

A retrospective ,non-interventional tissue study using archival materials collected through a patient's routine care, EVIDENCE aims to demonstrate that distant metastases in colorectal cancer are related to Extramural Venous Invasion (EMVI) and tumour deposits, not lymph nodes. As EVIDENCE is a retrospective study, there are no time dependent schedules for Case Report Form (CRF) completion or tissue submission.

It will be tested whether the vascular route of spread (as evidenced through EMVI and tumour deposits) is more important than lymph nodes in the development of metastatic disease. The sub-clonal origins of primary colorectal cancers, EMVI, tumour deposits, lymph nodes and distant metastases by reconstructing phylogenetic trees will be compared. A proof for a vascular route of spread rather than lymph nodes would lead to a paradigm shift in future decision making at national and international level.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Are aged 16 years or over with colorectal cancer
  • Colon / rectum has been surgically removed
  • Distant metastases has been surgically removed
  • Pre operative staging in the form of CT/MRI has been undertaken and images available for review

排除标准

  • Pathological complete response in the primary tumour
  • Local resection of the primary tumour
  • Inadequate quantity of tissue sample to perform analyses

结局指标

主要结局

Comparison of proportion of subjects where Extramural Venous Invasion (EMVI) and tumour deposits vs lymph nodes are associated with distant metastases

时间窗: 1 year from last registered patient

Proportion of subjects where EMVI and tumour deposits rather than lymph nodes are associated with distant metastases. This is to determine the route of spread of distant metastases.

次要结局

  • Comparison of tumour phylogenetic profile between primary tumour, EMVI, tumour deposits, metastases(1 year from last registered patient)
  • Comparison of tumour phylogenes between different metastatic sites and primary tumour(1 year from last registered patient)
  • Comparison of immunohistochemistry staining profile between primary tumour, EMVI, tumour deposits, metastases(1 year from last registered patient)
  • Comparison of overall survival based on clonal origins of metastases(1 year from last registered patient)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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