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EMVI as a Determinant of Metastasis in Colorectal Cancer

Sponsor: Imperial College London

NCT ID: NCT06646341

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 59 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by Imperial College London, looks at people aged 16 and over with colorectal cancer (cancer of the bowel). It is investigating whether something called EMVI (when tumour cells are seen in blood vessels near the tumour on scans) can help tell if the cancer may spread.

Who can take part

  • Aged 16 or over with colorectal cancer
  • The colon or rectum has been removed by surgery
  • Cancer that had spread to other parts of the body has been removed by surgery
  • Scans (CT or MRI) were done before surgery and the images are available to review

Who may not be able to

  • No cancer cells were found in the main tumour after treatment (a complete response)
  • The main tumour was removed using a local resection (a smaller operation)
  • Not enough tissue sample available to carry out the study tests

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
16 Years to 100 Years
Who
All
Number of participants
100
Started
2023-01-01
Last checked
2024-10

Plain English Summary

What is this study?

  • • Testing a new treatment for colo-rectal cancer
  • • Clinical study - 100 participants
  • • Bowel cancer is the fourth most commonly occurring cancer and the second highest cause of cancer deaths in the UK

Who can take part?

  • • Ages 16 Years to 100 Years
  • • Diagnosed with colo-rectal cancer

Where?

  • • Basingstoke - Hampshire Hospitals Nhs Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Colo-rectal Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years - 100 Years
  • Who can join: All genders

What the study is looking for

  • ✓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

Who cannot take part

  • ✗Pathological complete response in the primary tumour
  • ✗Local resection of the primary tumour
  • ✗Inadequate quantity of tissue sample to perform analyses
See the full criteria
Inclusion Criteria: 1. Are aged 16 years or over with colorectal cancer 2. Colon / rectum has been surgically removed 3. Distant metastases has been surgically removed 4. Pre operative staging in the form of CT/MRI has been undertaken and images available for review Exclusion Criteria: 1. Pathological complete response in the primary tumour 2. Local resection of the primary tumour 3. Inadequate quantity of tissue sample to perform analyses

Where Is This Study? (1 UK site)

Hampshire Hospitals Nhs Foundation Trust

Basingstoke RG24 9NA, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Caroline Martin

Sponsor contact

CONTACT

+44 (0) 7749 655 817 c.martin1@imperial.ac.uk

Syvella Ellis

Sponsor contact

CONTACT

+44 (0) 7732 315 234 syvella.ellis@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-10