An observational study in Colo-rectal Cancer, sponsored by Imperial College London. Recruiting at 1 site in United Kingdom. Open to participants aged 16 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Imperial College London · Observational
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.
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.
5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 100 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who have undergone a primary resection of their colon or rectum as well as a resection of a distant metastases
Exclusion Criteria:
Comparison of proportion of subjects where Extramural Venous Invasion (EMVI) and tumour deposits vs lymph nodes are associated with distant metastases
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.
Time frame: 1 year from last registered patient
Comparison of tumour phylogenetic profile between primary tumour, EMVI, tumour deposits, metastases
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
Time frame: 1 year from last registered patient
Comparison of tumour phylogenes between different metastatic sites and primary tumour
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)
Time frame: 1 year from last registered patient
Comparison of immunohistochemistry staining profile between primary tumour, EMVI, tumour deposits, metastases
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
Time frame: 1 year from last registered patient
Comparison of overall survival based on clonal origins of metastases
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
Time frame: 1 year from last registered patient
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Imperial College London