Clinical trial NCT03303547: Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits
Official title: Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adenocarcinoma of the Rectum
Keywords: MRI
Tissue
Imaging
Pathology
Rectal
Cancer
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Pelican Cancer Foundation
First posted: 2017-10-06
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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of the colon, sigmoid or rectum (proven by biopsy taken as part of routine clinical practice, patients to be withdrawn if not subsequently adenocarcinoma on pathology).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

Primary outcomes:
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
Secondary outcomes:
measure: To determine whether lesions classified as TD on Imaging correspond to the pathological diagnosis of TD.
timeFrame: Up to 2 years
measure: 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.
timeFrame: 1, 3 and 5 years
measure: To investigate features of the primary tumour compared with tumour deposits
timeFrame: Up to 2 years and up to 5 years follow up
measure: To investigate features of the primary tumour compared with lymph nodes
timeFrame: Up to 2 years and up to 5 years follow up
measure: 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.
timeFrame: Up to 2 years
measure: To objectively record the features seen which help distinguish a LN from an TD
timeFrame: Up to 2 years
measure: To assess inter-observer agreement between the local pathologist and the central reviewing pathologist.
timeFrame: Up to 2 years0
measure: To assess inter-observer agreement between the local radiologist and central reviewing radiologist.
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Marsden Hospital NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Imperial College London
name: Gina Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lord 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.