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Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

Sponsor: Imperial College London

NCT ID: NCT03303547

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
MRI mapping to guide pathological sampling of extranodal tumour deposits (diagnostic test)
How long the study runs
Study runs about 170 months (dates as stated)
About the drug or intervention
MRI mapping to guide pathological sampling of extranodal tumour deposits — diagnostic test: Radiologist to mark areas where extranodal disease is identified on MRI.
Patient visit burden
Not specified by the sponsor

In plain English

This study checks whether scans and laboratory tests on tissue removed at surgery agree when looking for small areas of cancer (tumour deposits) outside the lymph nodes. It includes people having surgery for a type of cancer called adenocarcinoma in the bowel (colon, sigmoid or rectum). The study is run by Imperial College London.

Who can take part

  • Aged 16 or over
  • Have a suspected first-time adenocarcinoma (a type of cancer) of the colon, sigmoid or rectum, proven by a tissue sample (biopsy) taken as part of normal care
  • Able to have surgery to remove the cancer
  • Have had scans to show how far the cancer has spread, including a scan before treatment starts
  • Having either surgery straight away, or treatment before surgery (called neoadjuvant therapy) – if treatment comes first, a scan after that treatment is also needed

Who may not be able to

  • Cancer that has come back after earlier treatment
  • Two or more tumours found at the same time (synchronous tumours)
  • Under 16 years old
  • Unable to give informed consent to take part

What taking part involves

  • • Scans to show the size and spread of the cancer
  • • Surgery to remove the cancer, with the removed tissue checked in the laboratory
  • • Some people have treatment before surgery (neoadjuvant therapy) and a further scan afterwards

Time commitment: Taking part involves the scans, surgery and (for some) treatment before surgery described above; how long the study lasts and any extra visits are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
16 Years and over
Who
All
Number of participants
200
Started
2017-10-16
Last checked
2024-10

Plain English Summary

What is this study?

  • • Testing a new treatment for adenocarcinoma of the rectum
  • • NA - 200 participants
  • • Any patient with a suspected primary adenocarcinoma of the colon, sigmoid or rectum undergoing surgery are eligible

Who can take part?

  • • Ages 16 Years and over
  • • Diagnosed with adenocarcinoma of the rectum

Where?

  • • London - Royal Marsden Hospital NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Adenocarcinoma of the Rectum

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Amenable to surgical resection.
  • ✓Disease spread assessed on imaging
  • ✓Patients having primary surgery and those undergoing before surgery treatment will be included.
  • ✓All must have had baseline staging scans and those undergoing before surgery therapy must also have had a...
  • ✓Patients aged 16 years and over

Who cannot take part

  • ✗Patients with recurrent tumours
  • ✗Synchronous tumours
  • ✗Under the age of 16 years
  • ✗Unable to give agreement to take part.
See the full criteria
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.

Where Is This Study? (1 UK site)

Royal Marsden Hospital NHS Foundation Trust

London SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Monica Terlizzo, PhDPrincipal Investigator

How to Get in Touch

Caroline Martin

Sponsor contact

CONTACT

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

Syvella Ellis

Sponsor contact

CONTACT

+44 (0) 7732 315 234 giclinicaltrials@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-10