Can extranodal tumour deposits be diagnosed on MRI? Protocol for a multicentre clinical trial (The COMET Trial)
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Published version
Author(s)
Type
Journal Article
Abstract
Introduction: Tumour deposits (TDs) are a poor prognostic marker when seen on pathology, and are worse than lymph node metastases (LNM). They are now being reported on Magnetic resonance imaging (MRI) as discontinuous nodules of extramural venous invasion but this diagnosis has not been validated and it is unclear how it correlates with the diagnosis of TDs on pathology.
Methods and analysis: This is a prospective interventional clinical trial which aims to directly map the location of TDs on MRI and correlate what is seen on MRI with the pathology findings at each location. All patients with rectal cancer undergoing resectional surgery are eligible (including those undergoing pre-operative therapy) The primary outcome is the prevalence of TDs seen on pathology. Secondary outcomes are to assess radiological and pathological interobserver agreement, assess the effect of TDs on prognosis and carry out exploratory work looking at differences between TDs and LNMs. The estimated sample size is 100 to detect a 2 fold increase in the pathological diagnosis of TD when MRI mapping is used.
Ethics and dissemination: Ethical approval has been granted from the South Central – Hampshire B Research and Ethics Committee (IRAS 217627). The study will be carried out under standard operative procedures within the Royal Marsden Hospital
Registration details: Registered on Clinicaltrials.gov NCT03303547
Methods and analysis: This is a prospective interventional clinical trial which aims to directly map the location of TDs on MRI and correlate what is seen on MRI with the pathology findings at each location. All patients with rectal cancer undergoing resectional surgery are eligible (including those undergoing pre-operative therapy) The primary outcome is the prevalence of TDs seen on pathology. Secondary outcomes are to assess radiological and pathological interobserver agreement, assess the effect of TDs on prognosis and carry out exploratory work looking at differences between TDs and LNMs. The estimated sample size is 100 to detect a 2 fold increase in the pathological diagnosis of TD when MRI mapping is used.
Ethics and dissemination: Ethical approval has been granted from the South Central – Hampshire B Research and Ethics Committee (IRAS 217627). The study will be carried out under standard operative procedures within the Royal Marsden Hospital
Registration details: Registered on Clinicaltrials.gov NCT03303547
Date Issued
2020-10-07
Date Acceptance
2020-08-21
Citation
BMJ Open, 2020, 10 (10), pp.1-7
ISSN
2044-6055
Publisher
BMJ Journals
Start Page
1
End Page
7
Journal / Book Title
BMJ Open
Volume
10
Issue
10
Copyright Statement
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
License URL
Identifier
https://bmjopen.bmj.com/content/10/10/e033395.info
Subjects
colorectal surgery
gastrointestinal imaging
gastrointestinal tumours
magnetic resonance imaging
surgical pathology
1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Publication Status
Published
Date Publish Online
2020-10-07