Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

NCT03303547 | Recruiting DMC

• 1 other identifier: DOCUMAS: 23HH8158
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Rectum

Keywords

MRI; Tissue; Imaging; Pathology; Rectal; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  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.

  1, 3 and 5 years

• To investigate features of the primary tumour compared with tumour deposits

  Up to 2 years and up to 5 years follow up

• To investigate features of the primary tumour compared with lymph nodes

  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.

  Up to 2 years

Study Arms (1)

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.

Diagnostic Test: MRI mapping to guide pathological sampling of extranodal tumour deposits

Interventions

MRI mapping to guide pathological sampling of extranodal tumour deposits DIAGNOSTIC_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.

MRI-Pathology N1c matching group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with recurrent tumours
• Synchronous tumours
• Under the age of 16 years
• Unable to give informed consent.

Sponsors & Collaborators

• Imperial College London: lead
• Pelican Cancer Foundation: collaborator

Study Sites (1)

Royal Marsden Hospital NHS Foundation Trust

London, Surrey, SM2 5PT, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 33033006 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Gina Brown, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Martin

CONTACT

+44 (0) 7749 655 817; c.martin1@imperial.ac.uk

Syvella Ellis

CONTACT

+44 (0) 7732 315 234; giclinicaltrials@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: October 6, 2017
• Study Start: October 16, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)