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

Primary Purpose

Adenocarcinoma of the Rectum

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

MRI mapping to guide pathological sampling of extranodal tumour deposits

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Rectum focused on measuring MRI, Tissue, Imaging, Pathology, Rectal, Cancer

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged 18 years of age and over presenting with primary adenocarcinoma of the rectum amenable to surgical resection. This will be diagnosed on tissue biopsy and disease spread assessed on CT and MRI. Both patients having primary surgery and those undergoing neoadjuvant treatment will be included. All must have had a baseline staging MRI and those undergoing neoadjuvant therapy must also have had a post-treatment MRI.

Exclusion Criteria:

Patients with recurrent or synchronous tumours, those who are unable to have an MRI scan (e.g pacemaker, contrast allergy, severe claustrophobia) and those under the age of 18 years or unable to give informed consent will be excluded.

Sites / Locations

Royal Marsden Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI-Pathology N1c matching group

Arm Description

MRI mapping will be used to guide pathologists to sample areas of the mesorectum where tumour deposits are likely to be present.

Outcomes

Primary Outcome Measures

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'

Secondary Outcome Measures

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

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

To investigate features of the primary tumour compared with tumour deposits

Comparison of immunohistochemical and morphological features of tumour

To investigate features of the primary tumour compared with lymph nodes

Comparison of immunohistochemical and morphological features of tumour

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"

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"

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

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

Full Information

NCT ID

NCT03303547

First Posted

September 13, 2017

Last Updated

September 1, 2023

Sponsor

Imperial College London

Collaborators

Pelican Cancer Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03303547

Brief Title

Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

Acronym

COMET

Official Title

Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 16, 2017 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Imperial College London

Collaborators

Pelican Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of the Rectum

Keywords

MRI, Tissue, Imaging, Pathology, Rectal, Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MRI-Pathology N1c matching group

Arm Type

Experimental

Arm Description

MRI mapping will be used to guide pathologists to sample areas of the mesorectum where tumour deposits are likely to be present.

Intervention Type

Diagnostic Test

Intervention Name(s)

MRI mapping to guide pathological sampling of extranodal tumour deposits

Intervention Description

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.

Primary Outcome Measure Information:

Title

To determine whether the prevalence of TD on pathology is found to be higher if imaging mapping is used.

Description

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'

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

To determine whether lesions classified as TD on Imaging correspond to the pathological diagnosis of TD.

Description

Correspondence of nodules identified as tumour deposits on imaging and nodules identified as tumour deposits on the corresponding pathology slice

Time Frame

Up to 2 years

Title

Description

Survival and recurrence outcomes according to Imaging and histopathology TD status

Time Frame

1, 3 and 5 years

Title

To investigate features of the primary tumour compared with tumour deposits

Description

Comparison of immunohistochemical and morphological features of tumour

Time Frame

Up to 2 years and up to 5 years follow up

Title

To investigate features of the primary tumour compared with lymph nodes

Description

Comparison of immunohistochemical and morphological features of tumour

Time Frame

Up to 2 years and up to 5 years follow up

Title

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.

Description

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"

Time Frame

Up to 2 years

Title

To objectively record the features seen which help distinguish a LN from an TD

Description

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"

Time Frame

Up to 2 years

Title

To assess inter-observer agreement between the local pathologist and the central reviewing pathologist.

Description

Overall comparison of professional agreement between specialists on TD status at recruiting site vs central review - description of location and number of tumour deposits

Time Frame

Up to 2 years0

Title

To assess inter-observer agreement between the local radiologist and central reviewing radiologist.

Description

Overall comparison of professional agreement between specialists on TD status at recruiting site vs central review - description of location and number of tumour deposits

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Patients with recurrent tumours Synchronous tumours Under the age of 16 years Unable to give informed consent.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caroline Martin

Phone

+44 (0) 7749 655 817

c.martin1@imperial.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Syvella Ellis

Phone

+44 (0) 7732 315 234

giclinicaltrials@imperial.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gina Brown, MD

Organizational Affiliation

Imperial College London

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Marsden Hospital NHS Foundation Trust

City

London

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cordelia Grant

cordelia.grant@rmh.nhs.uk

First Name & Middle Initial & Last Name & Degree

Monica Terlizzo, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33033006

Citation

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.

Results Reference

derived

Learn more about this trial

Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

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