Clinical trial NCT06646341: EMVI as a Determinant of Metastasis in Colorectal Cancer
Official title: EMVI as a Determinant of Metastasis in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colo-rectal Cancer
Keywords: Extramural Venous Invasion
Extranodal Tumour Deposits
Imaging and Pathology Biomarkers
Pelvic Recurrence
Colorectal Cancer
Local Advanced Rectal Cancer
Metastatic Spread
MRI staging
Phylogenesis
Rectal Cancer Recurrence
Sigmoid Cancer
Surgery for Pelvic Recurrence
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone a primary resection of their colon or rectum as well as a resection of a distant metastases

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: Comparison of proportion of subjects where Extramural Venous Invasion (EMVI) and tumour deposits vs lymph nodes are associated with distant metastases
timeFrame: 1 year from last registered patient
Secondary outcomes:
measure: Comparison of tumour phylogenetic profile between primary tumour, EMVI, tumour deposits, metastases
timeFrame: 1 year from last registered patient
measure: Comparison of tumour phylogenes between different metastatic sites and primary tumour
timeFrame: 1 year from last registered patient
measure: Comparison of immunohistochemistry staining profile between primary tumour, EMVI, tumour deposits, metastases
timeFrame: 1 year from last registered patient
measure: Comparison of overall survival based on clonal origins of metastases
timeFrame: 1 year from last registered patient
Other outcomes:
Locations:
city: Basingstoke
country: United Kingdom
facility: Hampshire Hospitals Nhs Foundation Trust
state: Hampshire
Study officials:
affiliation: Imperial College London
name: Gina Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: