RecruitingNot ApplicableNCT03303547

Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits


Sponsor

Imperial College London

Enrollment

200 participants

Start Date

Oct 16, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 Years

Inclusion Criteria6

  • 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of the colon, sigmoid or rectum (proven by biopsy taken as part of routine clinical practice, patients to be withdrawn if not subsequently adenocarcinoma on pathology).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 Criteria4

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

Interventions

DIAGNOSTIC_TESTMRI 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(1)

Royal Marsden Hospital NHS Foundation Trust

London, Surrey, United Kingdom

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NCT03303547


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