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NCT Number: NCT06646341

EMVI as a Determinant of Metastasis in Colorectal Cancer

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.

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Key information

Conditions

Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Sigmoid Diseases Sigmoid Neoplasms

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hampshire Hospitals Nhs Foundation Trust

Basingstoke, Hampshire, RG24 9NA, United Kingdom

Location status: Recruiting

Location contact

Amy Lord, MD

CONTACT

[email protected]

0784150064

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Comparison of tumour phylogenetic profile between primary tumour, EMVI, tumour deposits, metastases

    Time frame: 1 year from last registered patient

    Comparison of tumour phylogenetic profile between primary tumour, EMVI, tumour deposits, metastases. This is to investigate the clonal origins of metastases in relation to the primary tumour deposits, EMVI and lymph nodes

  2. Comparison of tumour phylogenes between different metastatic sites and primary tumour

    Time frame: 1 year from last registered patient

    Comparison of tumour phylogenes between different metastatic sites and primary tumour. This is to determine if there are different routes of spread to different organs (i.e. lung, liver, brain, peritoneal)

  3. Comparison of immunohistochemistry staining profile between primary tumour, EMVI, tumour deposits, metastases

    Time frame: 1 year from last registered patient

    Comparison of immunohistochemistry staining profile between primary tumour, EMVI, tumour deposits, metastases. This is to evaluate the similarities in the immunohistochemistry profile of metastases compared with primary tumour deposits, EMVI and lymph nodes

  4. Comparison of overall survival based on clonal origins of metastases

    Time frame: 1 year from last registered patient

    Comparison of overall survival based on clonal origins of metastases. This is to investigate the relationship between the clonal origins of metastases and outcomes according to primary tumour deposits, EMVI and lymph nodes

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Martin

CONTACT

[email protected]

+44 (0) 7749 655 817

Syvella Ellis

CONTACT

[email protected]

+44 (0) 7732 315 234

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: EVIDENCE

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Oct 17, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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