Reporting of Tumour Deposits in Colorectal Cancer by Radiology and Pathology (RADAR)

January 6, 2026 updated by: Imperial College London

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. When looking at scans before surgery, or
  2. when examining the removed bowel tissue under the microscope after surgery.

In the past, tumour deposits were not always recorded properly. This is because older cancer-staging systems (called TNM 5) used in the UK treated these spots differently, depending on their size, and sometimes labelled them as lymph nodes even when they were not. As a result, many tumour deposits were missed in reports.

Since 2018, the UK has been using an updated staging system (called TNM 8) that gives tumour deposits their own category. This means doctors are now expected to report them separately when they are found in the tissue around the bowel.

This matters because the investigators know that patients who have tumour deposits may have a higher risk of the cancer returning or spreading. Because of this, these patients might benefit from extra treatment-such as chemotherapy or radiotherapy-on top of surgery.

However, if tumour deposits are not routinely recorded on scans or pathology reports, doctors may not realise a patient has them. This means that:

  1. Patients may not get the most appropriate advice about their cancer, and
  2. Patients may miss out on treatments that could help reduce the chance of the cancer returning.

This research project aims to find out two things:

  1. Are tumour deposits being routinely reported on scans and pathology reports for rectal cancer since the newer TNM 8 system was introduced? And
  2. 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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background:

There is increasing evidence that Tumour Deposits (TDs) play an important role in determining prognosis in colorectal cancer patients, both on pathology and on pre-operative imaging (1-2). There is a great variation in their reported prevalence on pathology (1) depending on the staging system and pathology techniques used. Previous work to determine the prevalence of TDs in the UK has relied on the TNM 5 classification, since the 6th and 7th editions were not adopted into UK practice. In TNM 5, all tumour nodules of >3mm were classified as lymph nodes, regardless of whether there was evidence of underlying nodal architecture. Nodules of under 3mm were included in the T stage. Reporting of TDs only took place if the pathologist made specific mention of them in the body of the report, therefore the reported prevalence was very low (6%) compared to when detected on imaging (36%)(2). TNM 8, released in 2017, is the current Tumour Node Metastases staging system used for colorectal cancer (3) and was adopted in the UK from January 2018 onwards. In TNM 8 however, TDs in the subserosa, or in non-peritonealised pericolic or perirectal soft tissue without regional lymph node metastatic disease are reported as N1c. The aim of this multicentre retrospective evaluation is to understand if TDs are being routinely reported in imaging and pathology in rectal cancer patients since the introduction of TNM 8.

Rationale:

There is increasing evidence that TDs impact the recurrence of cancer and cancer death in patients with rectal cancer for the worse. These patients may therefore benefit from additional treatment with chemotherapy or radiotherapy. However, if we are not recording TDs routinely, and don't know at the time of deciding how to treat these patients that they have TDs, then we are not counselling patients properly as well as may not be offering them additional chemotherapy or radiotherapy.

Objectives:

Primary Objectives:

To determine whether, since the introduction of TNM 8, TDs are being routinely reported in staging of rectal cancer on imaging and pathology

Secondary Objective:

To determine if there is as positive association between the reporting of TDs and the reporting of Extramural Venous Invasion.

References:

Please see separate References Section

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • Basingstoke and North Hampshire Hospital
        • Contact:
        • Principal Investigator:
          • Amy Lord
      • Surrey Quays, United Kingdom, SM5 1AA
        • Epsom and St Helier University Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Tou Pin Chang
    • Select Your County
      • Croydon, Select Your County, United Kingdom, CR7 7YE
        • Croydon Health Services NHS Trusts
        • Contact:
        • Principal Investigator:
          • Annabel Shaw
      • London, Select Your County, United Kingdom, NW10 7NS
        • London North West University Healthcare NHS Trust
        • Contact:
        • Principal Investigator:
          • Nicola Hodges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Primary adenocarcinoma of the rectum (proven by biopsy)
  2. Undergone surgical resection between 01st January 2007 to 31st December 2017 inclusive for the TNM 5 cohort
  3. Undergone surgical resection between 01st January 2022 to 31st December 2024 inclusive for the TNM 8 cohort

3. Staging with MRI reports are available 4. Post-operative pathology report available 5. Patients aged 16 years and over

Exclusion Criteria:

  1. Synchronous metastatic tumours
  2. Under the age of 16 years
  3. MRI and/or pathology reports are not available

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
TNM5
Patients with rectal cancer diagnosed between 2007-2017 who were staged using TNM5
Other: No Intervention: Observational Cohort
No intervention is to be performed. This is an observational retrospective cohort study only
TNM8
Patients with rectal cancer diagnosed between 2022-2024 who were staged using TNM8
Other: No Intervention: Observational Cohort
No intervention is to be performed. This is an observational retrospective cohort study only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of Tumour Deposits
Time Frame: For MRI: MRI reporting within 8 weeks prior to surgery For pathology: Pathology reporting up to 4 weeks after surgery
  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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The correlation between reporting of tumour deposits and extramural venous invasion
Time Frame: For MRI: MRI reporting within 8 weeks prior to surgery For pathology: Pathology reporting up to 4 weeks after surgery
  1. The percentage of patients with extramural venous invasion on MRI among patients with MRI-detected tumour deposits. Measurement tool is standardised colorectal cancer pelvic MRI reporting.
  2. The percentage of patients with histopathological extramural venous invasion among patients with histopathologically confirmed tumour deposits. Measurement tool is standardised colorectal cancer histopathology reporting.
For MRI: MRI reporting within 8 weeks prior to surgery For pathology: Pathology reporting up to 4 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Epsom and St Helier University Hospitals NHS Trust
Croydon Health Services NHS Trust
Basingstoke and North Hampshire Hospital
London North West University Health Care NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 183491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD used in the results publication will be shared. At the time of publication of results, fully anonymised data will be made available to those that request it upon reasonable request.

IPD Sharing Time Frame

Study protocol which includes the statistical analysis plan is available for sharing immediately. Results will be available at the time of publication.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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