Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

Adenocarcinoma of the Rectum Clinical Trial

— COMET  

Official title:

Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03303547
• Other study ID #: DOCUMAS: 23HH8158
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: December 2029

Study information

• Verified date: September 2023
• Source: Imperial College London
• Contact: Caroline Martin
• Phone: +44 (0) 7749 655 817
• Email: c.martin1[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2029
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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of the colon, sigmoid or rectum (proven by biopsy taken as part of routine clinical practice, patients to be withdrawn if not subsequently adenocarcinoma on pathology).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

Related Conditions & MeSH terms

• Adenocarcinoma of the Rectum

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Royal Marsden Hospital NHS Foundation Trust	London	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Pelican Cancer Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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