Clinical trial · Interventional
Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Rectum | Rectal Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI mapping to guide pathological sampling of extranodal tumour deposits | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI-Pathology N1c matching group
- description
- MRI mapping will be used to guide pathologists to sample areas of the mesorectum where tumour deposits are likely to be present.
- interventionNames
- Diagnostic Test: MRI mapping to guide pathological sampling of extranodal tumour deposits
Primary outcomes (1)
- measure
- To determine whether the prevalence of TD on pathology is found to be higher if imaging mapping is used.
- timeFrame
- Up to 2 years
- description
- 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 (8)
- measure
- To determine whether lesions classified as TD on Imaging correspond to the pathological diagnosis of TD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLord 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