Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
ID03303547

Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits in Adenocarcinoma of the Colon, Sigmoid, or Rectum

Led by Imperial College London · Updated on 2024-10-17

200

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

I

Imperial College London

Lead Sponsor

P

Pelican Cancer Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying patients with suspected primary adenocarcinoma of the colon, sigmoid, or rectum who are scheduled for surgery. The goal is to see if using imaging mapping techniques before surgery can improve how well imaging and pathology agree in detecting tumour deposits. This study is a prospective, interventional, multi-center trial aiming to assess if additional radiological and pathological assessments can provide supplementary diagnostic information that might influence treatment and prognosis discussions. The study involves using MRI mapping to identify lymph nodes and tumour deposits on pre-operative scans. Radiologists will mark areas where extranodal disease is detected, and this map will be shared with pathologists before they process the surgical specimen. This approach guides the pathological sampling of tumour deposits in the mesorectum, which may lead to better pathological staging and impact treatment decisions. Patients will receive standard care and follow-up at their local hospitals. Participants will be followed for up to five years to monitor outcomes such as disease-free survival, overall survival, and time to local recurrence. Assessments include comparing imaging and pathology diagnoses of tumour deposits, evaluating features of the primary tumour and lymph nodes, and measuring agreement between local and central radiologists and pathologists. The primary outcome is to determine if imaging mapping increases detection of tumour deposits on pathology within two years. Safety monitoring and long-term follow-up are included as part of the study.

CONDITIONS

Brief Title

Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suspected primary adenocarcinoma of the colon, sigmoid or rectum confirmed by biopsy
  • Scheduled for surgical resection
  • Disease spread assessed by imaging
  • Patients undergoing primary surgery or neoadjuvant treatment
  • Have had baseline staging scans; post-treatment scans if neoadjuvant therapy was given
  • Aged 16 years or older
Not Eligible

You will not qualify if you...

  • Recurrent tumours
  • Synchronous tumours
  • Under 16 years of age
  • Unable to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to the time of surgical resection and pathological assessment

Participants undergo MRI mapping to guide pathologists in sampling areas of the mesorectum where tumour deposits are likely to be present. This helps improve pathological staging and may influence treatment decisions.

Visits aligned with routine imaging and surgical care

Follow-up

Duration - Up to 5 years

Participants are monitored for up to 5 years to assess disease-free survival, overall survival, local recurrence, and the accuracy of imaging and pathological diagnosis of tumour deposits.

Follow-up visits scheduled according to local care protocols

Trial Site Locations

Total: 1 location

1

Royal Marsden Hospital NHS Foundation Trust

London, Surrey, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

C

Caroline Martin

S

Syvella Ellis

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial