EMVI as a Determinant of Metastasis in Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colo-rectal Cancer. Basic parameters: 16 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Comparison of tumour phylogenetic profile between primary tumour, EMVI, tumour deposits, metastases [Time frame: 1 year from last registered patient]
- Comparison of tumour phylogenes between different metastatic sites and primary tumour [Time frame: 1 year from last registered patient]
- Comparison of immunohistochemistry staining profile between primary tumour, EMVI, tumour deposits, metastases [Time frame: 1 year from last registered patient]
- Comparison of overall survival based on clonal origins of metastases [Time frame: 1 year from last registered patient]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-only
Study locations
United Kingdom · 1 center
- Hampshire Hospitals Nhs Foundation Trust — Basingstoke
Identifiers
NCT: NCT06646341 · DOCUMAS: 22HH7583