Reporting of Tumour Deposits in Colorectal Cancer by Radiology and Pathology

NCT07345273 | Not Yet Recruiting

• 1 other identifier: 183491
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 4

Brief Summary

Recent research shows that tumour deposits-small spots of cancer found near the main bowel tumour-may give doctors important information about how aggressive the cancer is and how likely it is to come back. Doctors can find tumour deposits either:

1. 1.When looking at scans before surgery, or
2. 2.when examining the removed bowel tissue under the microscope after surgery.
3. 3.Patients may not get the most appropriate advice about their cancer, and
4. 4.Patients may miss out on treatments that could help reduce the chance of the cancer returning.
5. 5.Are tumour deposits being routinely reported on scans and pathology reports for rectal cancer since the newer TNM 8 system was introduced? And
6. 6.Is there a link between reporting tumour deposits and another important finding called EMVI (extramural vascular invasion), which also affects cancer behaviour and treatment decisions?

Conditions

Rectal Adenocarcinoma

Keywords

Rectal Adenocarcinoma; Tumour Deposits; TNM staging; Extramural Venous Invasion

Outcome Measures

Primary Outcomes (1)

• Frequency of Tumour Deposits

  1. The frequency of Tumour Deposits on MRI in the TNM 8 cohort compared to TNM 5 cohort and 2. The frequency of Tumour Deposits on pathology in the TNM 8 cohort compared to TNM 5 cohort

  For MRI: MRI reporting within 8 weeks prior to surgery For pathology: Pathology reporting up to 4 weeks after surgery

Secondary Outcomes (1)

• The correlation between reporting of tumour deposits and extramural venous invasion

  For MRI: MRI reporting within 8 weeks prior to surgery For pathology: Pathology reporting up to 4 weeks after surgery

Study Arms (2)

TNM5

Patients with rectal cancer diagnosed between 2007-2017 who were staged using TNM5

Other: No Intervention: Observational Cohort

TNM8

Patients with rectal cancer diagnosed between 2022-2024 who were staged using TNM8

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

No intervention is to be performed. This is an observational retrospective cohort study only

TNM5; TNM8

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients (\>16 years old) with primary adenocarcinoma of the rectum who have undergone resectional surgery

You may qualify if:

• Primary adenocarcinoma of the rectum (proven by biopsy)
• Undergone surgical resection between 01st January 2007 to 31st December 2017 inclusive for the TNM 5 cohort
• Undergone surgical resection between 01st January 2022 to 31st December 2024 inclusive for the TNM 8 cohort
• \. Staging with MRI reports are available 4. Post-operative pathology report available 5. Patients aged 16 years and over

You may not qualify if:

• Synchronous metastatic tumours
• Under the age of 16 years
• MRI and/or pathology reports are not available

Sponsors & Collaborators

• Imperial College London: lead
• Croydon Health Services NHS Trust: collaborator
• Epsom and St Helier University Hospitals NHS Trust: collaborator
• Basingstoke and North Hampshire Hospital: collaborator
• London North West University Health Care NHS Trust: collaborator

Study Sites (4)

Croydon Health Services NHS Trusts

Croydon, Select Your County, CR7 7YE, United Kingdom

Location

London North West University Healthcare NHS Trust

London, Select Your County, NW10 7NS, United Kingdom

Location

Basingstoke and North Hampshire Hospital

Basingstoke, RG24 9NA, United Kingdom

Location

Epsom and St Helier University Hospitals NHS Trust

Surrey Quays, SM5 1AA, United Kingdom

Location

Related Publications (3)

• Amin MB, Edge SB, Greene FL, et al., editors. AJCC cancer staging manual. 8th ed. New York: Springer; 2017.

  BACKGROUND

• Sekhon Inderjit Singh HK, Lord A, Pawa N, Brown G. The Prognostic Impact of Imaging Detected Tumor Deposits in Rectal Cancer: A Systematic Review and Meta-analysis. Ann Surg Oncol. 2026 Jan;33(1):199-209. doi: 10.1245/s10434-025-18371-w. Epub 2025 Sep 30.

  PMID: 41028637 BACKGROUND

• Lord AC, D'Souza N, Pucher PH, Moran BJ, Abulafi AM, Wotherspoon A, Rasheed S, Brown G. Significance of extranodal tumour deposits in colorectal cancer: A systematic review and meta-analysis. Eur J Cancer. 2017 Sep;82:92-102. doi: 10.1016/j.ejca.2017.05.027. Epub 2017 Jun 23.

  PMID: 28651160 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Gina Brown

CONTACT

07917302097; gina.brown@imperial.ac.uk

Harpreet Sekhon

CONTACT

07923595222; hks224@ic.ac.uk

Study Design

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

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 15, 2026
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol which includes the statistical analysis plan is available for sharing immediately. Results will be available at the time of publication.
• Access Criteria: Anyone will be able to access the IPD and supporting information. The will be able to access the study protocol which includes the statistical analysis plan and anonymised individual participant data. They can access it by emailing Prof. Brown or Harpreet Sekhon at gina.brown@imperial.ac.uk, giclinicaltrials@imperial.ac.uk or hks224@ic.ac.uk Alternatively, it will be released onto the ClinicalTrials.gov record at the time of Results publication

Locations

GB (4)