Rectal AdenocarcinomaRADARNCT07345273
Reporting of Tumour Deposits in Colorectal Cancer by Radiology and Pathology
An observational study of Rectal Adenocarcinoma, run by Imperial College London at 4 sites in United Kingdom.
Trial 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. When looking at scans before surgery, or 2. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Rectal Adenocarcinoma
- How many people
- 225 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Feb 2026to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients (>16 years old) with primary adenocarcinoma of the rectum who have undergone resectional surgery
Who may be able to join
- 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
- 3. Staging with MRI reports are available 4. Post-operative pathology report available 5. Patients aged 16 years and over
Who cannot join
- Synchronous metastatic tumours
- Under the age of 16 years
- MRI and/or pathology reports are not available
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom4 sites
Basingstoke and North Hampshire Hospital
Basingstoke, RG24 9NA
Amy Lord, 07841590064, amycharlottelord@gmail.com
Amy Lord
Croydon Health Services NHS Trusts
Croydon, Select Your County, CR7 7YE
Annabel Shaw, 07708925886, annabel.shaw@nhs.net
Annabel Shaw
London North West University Healthcare NHS Trust
London, Select Your County, NW10 7NS
Nicola Hodges, 07702088521, nicola.hodges@nhs.net
Nicola Hodges
Epsom and St Helier University Hospitals NHS Trust
Surrey Quays, SM5 1AA
Tou Pin Chang, toupin.chang@nhs.net
Tou Pin Chang
About this study
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:
Read more
- When looking at scans before surgery, or
- 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:
- Patients may not get the most appropriate advice about their cancer, and
- 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:
- Are tumour deposits being routinely reported on scans and pathology reports for rectal cancer since the newer TNM 8 system was introduced? And
- 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?
Read the 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
- Conditions
- Rectal Adenocarcinoma
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Rectal Adenocarcinoma, Tumour Deposits, TNM staging, Extramural Venous Invasion
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention is to be performed. This is an observational retrospective cohort study only
| Study group | Role | What they receive |
|---|---|---|
| TNM5 | Patients with rectal cancer diagnosed between 2007-2017 who were staged using TNM5 Receives: Other: No Intervention: Observational Cohort | |
| TNM8 | Patients with rectal cancer diagnosed between 2022-2024 who were staged using TNM8 Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Tumour Deposits
- The frequency of Tumour Deposits on MRI in the TNM 8 cohort compared to TNM 5 cohort and
- The frequency of Tumour Deposits on pathology in the TNM 8 cohort compared to TNM 5 cohort
Measured: 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
- 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.
- The percentage of patients with histopathological extramural venous invasion among patients with histopathologically confirmed tumour deposits. Measurement tool is standardised colorectal cancer histopathology reporting.
Measured: For MRI: MRI reporting within 8 weeks prior to surgery For pathology: Pathology reporting up to 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Croydon Health Services NHS Trust, Epsom and St Helier University Hospitals NHS Trust, Basingstoke and North Hampshire Hospital, London North West University Health Care NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345273
- Sponsor's protocol ID
- 183491
- Acronym
- RADAR
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Amin MB, Edge SB, Greene FL, et al., editors. AJCC cancer staging manual. 8th ed. New York: Springer; 2017.
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.
PubMed 41028637Lord 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.
PubMed 28651160
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reporting of Tumour Deposits in Colorectal Cancer by Radiology and Pathology
- ClinicalTrials.gov ID
- NCT07345273
- Acronym / sponsor ID
- RADAR / 183491
- Conditions
- Rectal Adenocarcinoma
- Keywords
- Rectal Adenocarcinoma, Tumour Deposits, TNM staging, Extramural Venous Invasion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Croydon Health Services NHS Trust, Epsom and St Helier University Hospitals NHS Trust, Basingstoke and North Hampshire Hospital, London North West University Health Care NHS Trust
- Study start
- Feb 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- When looking at scans before surgery, or
- 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:
- Patients may not get the most appropriate advice about their cancer, and
- 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:
- Are tumour deposits being routinely reported on scans and pathology reports for rectal cancer since the newer TNM 8 system was introduced? And
- 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?
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNM5 | – | Other: No Intervention: Observational CohortPatients with rectal cancer diagnosed between 2007-2017 who were staged using TNM5 |
| TNM8 | – | Other: No Intervention: Observational CohortPatients with rectal cancer diagnosed between 2022-2024 who were staged using TNM8 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients (>16 years old) with primary adenocarcinoma of the rectum who have undergone resectional surgery
Key inclusion criteria (4 listed)
- 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
- 3. Staging with MRI reports are available 4. Post-operative pathology report available 5. Patients aged 16 years and over
Key exclusion criteria (3 listed)
- Synchronous metastatic tumours
- Under the age of 16 years
- MRI and/or pathology reports are not available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNo intervention is to be performed. This is an observational retrospective cohort study only | Other | TNM5, TNM8 |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- BackgroundAmin MB, Edge SB, Greene FL, et al., editors. AJCC cancer staging manual. 8th ed. New York: Springer; 2017.
- Background: PubMed 41028637Sekhon 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.
- Background: PubMed 28651160Lord 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Adenocarcinoma, run by Imperial College London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gina Brown (07917302097, gina.brown@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07345273, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.