EMVI as a Determinant of Metastasis in Colorectal Cancer

NCT06646341 | Recruiting

• 1 other identifier: DOCUMAS: 22HH7583
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year from last registered patient

Secondary Outcomes (4)

• Comparison of tumour phylogenetic profile between primary tumour, EMVI, tumour deposits, metastases

  1 year from last registered patient

• Comparison of tumour phylogenes between different metastatic sites and primary tumour

  1 year from last registered patient

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

  1 year from last registered patient

• Comparison of overall survival based on clonal origins of metastases

  1 year from last registered patient

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hampshire Hospitals Nhs Foundation Trust

Basingstoke, Hampshire, RG24 9NA, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy and resection specimens: Formalin-Fixed Paraffin-Embedded (FFPE) tissue blocks, (Hematoxylin and Eosin) H\&E slides, High resolution digital slides

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms; Sigmoid Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Sigmoid Diseases

Study Officials

• Gina Brown, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Martin

CONTACT

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

Syvella Ellis

CONTACT

+44 (0) 7732 315 234; syvella.ellis@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

GB (1)