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NCT Number: NCT03303547

Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

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.

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Key information

Conditions

Adenocarcinoma of the Rectum Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Marsden Hospital NHS Foundation Trust

London, Surrey, SM2 5PT, United Kingdom

Location status: Recruiting

Location contact

Cordelia Grant

CONTACT

[email protected]

Monica Terlizzo, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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of the colon, sigmoid or rectum (proven by biopsy taken as part of routine clinical practice, patients to be withdrawn if not subsequently adenocarcinoma on pathology).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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Up to 2 years

    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 outcomes

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

    Time frame: Up to 2 years

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

  2. 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.

    Time frame: 1, 3 and 5 years

    Survival and recurrence outcomes according to Imaging and histopathology TD status

  3. To investigate features of the primary tumour compared with tumour deposits

    Time frame: Up to 2 years and up to 5 years follow up

    Comparison of immunohistochemical and morphological features of tumour

  4. To investigate features of the primary tumour compared with lymph nodes

    Time frame: Up to 2 years and up to 5 years follow up

    Comparison of immunohistochemical and morphological features of tumour

  5. 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.

    Time frame: Up to 2 years

    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"

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

    Time frame: Up to 2 years

    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"

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

    Time frame: Up to 2 years0

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

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

    Time frame: Up to 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Martin

CONTACT

[email protected]

+44 (0) 7749 655 817

Syvella Ellis

CONTACT

[email protected]

+44 (0) 7732 315 234

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Pelican Cancer Foundation

Registry information

Acronym: COMET

Important dates

Study start
2017
Primary completion
2026
Study completion
2031
First posted
Oct 6, 2017
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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