Adenocarcinoma of the RectumCOMETNCT03303547
Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits
A study testing MRI mapping to guide pathological sampling of extranodal tumour deposits in people with Adenocarcinoma of the Rectum, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Any patient with a suspected primary adenocarcinoma of the colon, sigmoid or rectum undergoing surgery are eligible. The date of surgery must be known prior to registration. This trial aims to determine if image mapping techniques can improve the concordance between imaging and pathology detection of tumour deposits. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Adenocarcinoma of the Rectum
- What is being tested?
- MRI mapping to guide pathological sampling of extranodal tumour deposits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2017to Dec 2031
- Phase
- Interventional
- 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
Who may be able to join
- Suspected primary adenocarcinoma of the colon, sigmoid or rectum (proven by biopsy taken as part of routine clinical practice, patients to be withdrawn if not subsequently adenocarcinoma on pathology).
- Amenable to surgical resection.
- Disease spread assessed on imaging
- Patients having primary surgery and those undergoing neoadjuvant treatment will be included.
- All must have had baseline staging scans and those undergoing neoadjuvant therapy must also have had a post-treatment scan.
- Patients aged 16 years and over
Who cannot join
- Patients with recurrent tumours
- Synchronous tumours
- Under the age of 16 years
- Unable to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden Hospital NHS Foundation Trust
London, Surrey, SM2 5PT
Cordelia Grant, cordelia.grant@rmh.nhs.uk
Monica Terlizzo, PhD
About this study
Any patient with a suspected primary adenocarcinoma of the colon, sigmoid or rectum undergoing surgery are eligible. The date of surgery must be known prior to registration. This trial aims to determine if image mapping techniques can improve the concordance between imaging and pathology detection of tumour deposits. Lymph nodes and tumour deposits will be identified on pre-operative scans and mapped by radiologists then shared with pathologists prior to processing the resected specimen. Patients will be managed at their local hospital with standard follow-up. Patients will be followed up for 5 years.
Read the detailed description
A prospective interventional multi-centre study, COMET aims to prove the accuracy of imaging diagnosis of extranodal tumour deposits (TD) and their adverse effect on prognosis of colorectal cancers. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.
- Conditions
- Adenocarcinoma of the Rectum
- Being tested
- MRI mapping to guide pathological sampling of extranodal tumour deposits
- Keywords
- MRI, Tissue, Imaging, Pathology, Rectal, Cancer
- Medical subject headings
- Rectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI mapping to guide pathological sampling of extranodal tumour depositsDiagnostic test
Radiologist to mark areas where extranodal disease is identified on MRI. The pathologist will use this to take additional samples for analysis. This will allow better pathological staging and will affect treatment decisions for patients.
| Study group | Role | What they receive |
|---|---|---|
| MRI-Pathology N1c matching group | Experimental | MRI mapping will be used to guide pathologists to sample areas of the mesorectum where tumour deposits are likely to be present. Receives: Diagnostic Test: MRI mapping to guide pathological sampling of extranodal tumour deposits |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether the prevalence of TD on pathology is found to be higher if imaging mapping is used.
Comparison of the proportion of patients with TD on imaging with proportion of patients with TD on histopathology defined as 'nodules without definite features of lymph node architecture'
Measured: Up to 2 years
Secondary outcomes (8)
To determine whether lesions classified as TD on Imaging correspond to the pathological diagnosis of TD.
Correspondence of nodules identified as tumour deposits on imaging and nodules identified as tumour deposits on the corresponding pathology slice
Measured: Up to 2 years
To determine the effect of Imaging and pathological diagnosis of TD on disease free survival (at one, three and five years), overall survival (at one, three and five years) and time to local recurrence.
Survival and recurrence outcomes according to Imaging and histopathology TD status
Measured: 1, 3 and 5 years
To investigate features of the primary tumour compared with tumour deposits
Comparison of immunohistochemical and morphological features of tumour
Measured: Up to 2 years and up to 5 years follow up
To investigate features of the primary tumour compared with lymph nodes
Comparison of immunohistochemical and morphological features of tumour
Measured: Up to 2 years and up to 5 years follow up
To objectively record the features seen which help distinguish a LN from an TD and attempt to refine and clarify the definitions used in pathology.
Comparison of histopathological known features in patients with MR defined TD vs lymph nodes e.g. capsule, peripheral lymphocyte ring, vessel wall, "lone arteriole sign"
Measured: Up to 2 years
To objectively record the features seen which help distinguish a LN from an TD
Comparison of histopathological known features in patients with MR defined TD vs lymph nodes e.g. capsule, peripheral lymphocyte ring, vessel wall, "lone arteriole sign"
Measured: Up to 2 years
To assess inter-observer agreement between the local pathologist and the central reviewing pathologist.
Overall comparison of professional agreement between specialists on TD status at recruiting site vs central review - description of location and number of tumour deposits
Measured: Up to 2 years0
To assess inter-observer agreement between the local radiologist and central reviewing radiologist.
Overall comparison of professional agreement between specialists on TD status at recruiting site vs central review - description of location and number of tumour deposits
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start16 Oct 2017
- Primary completionDec 2026 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenocarcinoma of the RectumStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Gina Brown, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303547
- Sponsor's protocol ID
- DOCUMAS: 23HH8158
- Acronym
- COMET
- Status last verified
- Oct 2024
- First submitted
- 13 Sep 2017
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lord AC, Moran B, Abulafi M, Rasheed S, Nagtegaal ID, Terlizzo M, Brown G. Can extranodal tumour deposits be diagnosed on MRI? Protocol for a multicentre clinical trial (the COMET trial). BMJ Open. 2020 Oct 7;10(10):e033395. doi: 10.1136/bmjopen-2019-033395.
PubMed 33033006
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits
- ClinicalTrials.gov ID
- NCT03303547
- Acronym / sponsor ID
- COMET / DOCUMAS: 23HH8158
- Conditions
- Adenocarcinoma of the Rectum
- Keywords
- MRI, Tissue, Imaging, Pathology, Rectal, Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 6 Oct 2017 (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.
Any patient with a suspected primary adenocarcinoma of the colon, sigmoid or rectum undergoing surgery are eligible. The date of surgery must be known prior to registration. This trial aims to determine if image mapping techniques can improve the concordance between imaging and pathology detection of tumour deposits. Lymph nodes and tumour deposits will be identified on pre-operative scans and mapped by radiologists then shared with pathologists prior to processing the resected specimen. Patients will be managed at their local hospital with standard follow-up. Patients will be followed up for 5 years.
Detailed description
A prospective interventional multi-centre study, COMET aims to prove the accuracy of imaging diagnosis of extranodal tumour deposits (TD) and their adverse effect on prognosis of colorectal cancers. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI-Pathology N1c matching group | Experimental | Diagnostic Test: MRI mapping to guide pathological sampling of extranodal tumour depositsMRI mapping will be used to guide pathologists to sample areas of the mesorectum where tumour deposits are likely to be present. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Suspected primary adenocarcinoma of the colon, sigmoid or rectum (proven by biopsy taken as part of routine clinical practice, patients to be withdrawn if not subsequently adenocarcinoma on pathology).
- Amenable to surgical resection.
- Disease spread assessed on imaging
- Patients having primary surgery and those undergoing neoadjuvant treatment will be included.
- All must have had baseline staging scans and those undergoing neoadjuvant therapy must also have had a post-treatment scan.
Key exclusion criteria (4 listed)
- Patients with recurrent tumours
- Synchronous tumours
- Under the age of 16 years
- Unable to give informed consent.
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 |
|---|---|---|
| MRI mapping to guide pathological sampling of extranodal tumour depositsRadiologist to mark areas where extranodal disease is identified on MRI. The pathologist will use this to take additional samples for analysis. This will allow better pathological staging and will affect treatment decisions for patients. | Diagnostic test | MRI-Pathology N1c matching group |
Primary outcome
To determine whether the prevalence of TD on pathology is found to be higher if imaging mapping is used.
Time frame: Up to 2 years
Comparison of the proportion of patients with TD on imaging with proportion of patients with TD on histopathology defined as 'nodules without definite features of lymph node architecture'
8 secondary outcomes
To determine whether lesions classified as TD on Imaging correspond to the pathological diagnosis of TD.
Time frame: Up to 2 years
To determine the effect of Imaging and pathological diagnosis of TD on disease free survival (at one, three and five years), overall survival (at one, three and five years) and time to local recurrence.
Time frame: 1, 3 and 5 years
To investigate features of the primary tumour compared with tumour deposits
Time frame: Up to 2 years and up to 5 years follow up
To investigate features of the primary tumour compared with lymph nodes
Time frame: Up to 2 years and up to 5 years follow up
To objectively record the features seen which help distinguish a LN from an TD and attempt to refine and clarify the definitions used in pathology.
Time frame: Up to 2 years
To objectively record the features seen which help distinguish a LN from an TD
Time frame: Up to 2 years
To assess inter-observer agreement between the local pathologist and the central reviewing pathologist.
Time frame: Up to 2 years0
To assess inter-observer agreement between the local radiologist and central reviewing radiologist.
Time frame: Up to 2 years
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 17 Oct 2024.
- Derived from this study: PubMed 33033006Lord AC, Moran B, Abulafi M, Rasheed S, Nagtegaal ID, Terlizzo M, Brown G. Can extranodal tumour deposits be diagnosed on MRI? Protocol for a multicentre clinical trial (the COMET trial). BMJ Open. 2020 Oct 7;10(10):e033395. doi: 10.1136/bmjopen-2019-033395.
- Individual participant dataSharing planned: No
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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.
Gina Brown, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI mapping to guide pathological sampling of extranodal tumour deposits in people with Adenocarcinoma of the Rectum, run by Imperial College London at 1 site 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Caroline Martin (+44 (0) 7749 655 817, c.martin1@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether the prevalence of TD on pathology is found to be higher if imaging mapping is used. (time frame: Up to 2 years). 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 NCT03303547, which also lists 1 linked publication.
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 17 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.