Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

Study Overview
=================
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.

Official Title
-----------------
Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

Conditions
-----------------
Adenocarcinoma of the Rectum

Intervention / Treatment
-----------------
* Diagnostic Test: MRI mapping to guide pathological sampling of extranodal tumour deposits


Participation Criteria
=================
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of the colon, sigmoid or rectum (proven by biopsy taken as part of routine clinical practice, patients to be withdrawn if not subsequently adenocarcinoma on pathology).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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI-Pathology N1c matching group<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Tissue, Imaging, Pathology, Rectal, Cancer