Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits (COMET)

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.

Study Overview

• Status: Recruiting
• Conditions: Adenocarcinoma of the Rectum
• Intervention / Treatment: Diagnostic test: MRI mapping to guide pathological sampling of extranodal tumour deposits

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Martin; Phone Number: +44 (0) 7749 655 817; Email: c.martin1@imperial.ac.uk
• Study Contact Backup: Name: Syvella Ellis; Phone Number: +44 (0) 7732 315 234; Email: giclinicaltrials@imperial.ac.uk

Study Locations

• United Kingdom
  • Surrey
    • London, Surrey, United Kingdom, SM2 5PT
      • Recruiting
      • Royal Marsden Hospital NHS Foundation Trust
      • Contact: Cordelia Grant; Email: cordelia.grant@rmh.nhs.uk
      • Principal Investigator: Monica Terlizzo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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of the colon, sigmoid or rectum (proven by biopsy taken as part of routine clinical practice, patients to be withdrawn if not subsequently adenocarcinoma on pathology).
2. Amenable to surgical resection.
3. Disease spread assessed on imaging
4. Patients having primary surgery and those undergoing neoadjuvant treatment will be included.
5. All must have had baseline staging scans and those undergoing neoadjuvant therapy must also have had a post-treatment scan.
6. Patients aged 16 years and over

Exclusion Criteria:

1. Patients with recurrent tumours
2. Synchronous tumours
3. Under the age of 16 years
4. Unable to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRI-Pathology N1c matching group; MRI mapping will be used to guide pathologists to sample areas of the mesorectum where tumour deposits are likely to be present.	Diagnostic test: MRI mapping to guide pathological sampling of extranodal tumour deposits; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	1, 3 and 5 years
To investigate features of the primary tumour compared with tumour deposits	Comparison of immunohistochemical and morphological features of tumour	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	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"	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"	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	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	Up to 2 years

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Pelican Cancer Foundation
• Investigators: Principal Investigator: Gina Brown, MD, Imperial College London

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: October 5, 2017
• First Posted (Actual): October 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Cancer; Imaging; Tissue; Pathology; Rectal
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Extranodal Extension
• Other Study ID Numbers: DOCUMAS: 23HH8158

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No