Rectal CancerPRESERVENCT04103372
Pre-therapeutic MRI Assessment of Early-Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery
A study testing MRI scan and Radiologist training in people with Rectal Cancer and Colo-rectal Cancer, run by Imperial College London at 23 sites in United Kingdom.
Trial summary
When a patient is diagnosed with a rectal (bowel) polyp or cancer, radiology doctors read MRI scans to describe how deeply the cancer invades into the bowel wall (this is the 'stage' of the cancer). In this project, we will teach radiologists to find more early-stage rectal cancers. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Rectal Cancer, Colo-rectal Cancer
- What is being tested?
- MRI scan and Radiologist training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 23 sitesUnited Kingdom
- Study dates
- 1 Sep 2024to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a rectal tumour or suspected tumour less than or equal to T3b on MRI stage or pT2 or less after excision, or 20mm or more on endoscopy with suspicion of malignancy
- Be aged 16 years or over
Who cannot join
- Have metastatic disease at time of initial staging
- Have a biopsy-proven rectal malignancy which is not adenocarcinoma
- Are contraindicated for MRI
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
United Kingdom23 sites, 23 recruiting
- Recruiting
Buckinghamshire Healthcare Nhs Trust
Amersham, Buckinghamshire, AMERSHAM
Principal Investigator, arnold.goede@nhs.net
- Not yet recruiting
Hampshire Hospitals Nhs Foundation Trust
Basingstoke, Hampshire, RG24 9NA
Principal Investigator, franessco.difabio@hhft.nhs.uk
- Not yet recruiting
Frimley Health Nhs Foundation Trust
Camberley, Surrey, GU16 7UJ
Principal Investigator, ahmed.nizar@nhs.net
- Not yet recruiting
Kent & Canterbury Hospital
Canterbury, KENT, CT1 3NG
Principal Investigator, ztsiamoulos@nhs.net
- Not yet recruiting
St Helier Hospital
Carshalton, Surrey, SM5 1AA
Principal Investigator, ashishgupta@nhs.net
- Not yet recruiting
St Marks Bowel Cancer Screening Centre
Harrow, HA1 3UJ
Principal Investigator, norikosuzuki@nhs.net
- Not yet recruiting
Westmorland General Hospital
Kendal, Lancashire, LA9 7RG
Principal Investigator, manaswini.choudhary@mbht.nhs.uk
- Not yet recruiting
Kingston Hospital Nhs Foundation Trust
Kingston upon Thames, Surrey, KT2 7QB
Principal Investigator, svetlana.balyasnikova@nhs.net
- Not yet recruiting
Leicester Royal Infirmary
Leicester, Leicestershire, LE1 5WW
Principal Investigator, vikas.shah@uhl-tr.nhs.uk
- Not yet recruiting
University College London Hospitals Nhs Foundation Trust
London, Greater London, NW1 2PG
Principal Investigator, maira.hameed1@nhs.net
- Not yet recruiting
King'S College Hospital Nhs Foundation Trust
London, Greater London, SE5 9RS
Principal Investigator, amynhaji@nhs.net
- Not yet recruiting
West Middlesex Hospital
London, Greater London, SW10 9NH
Principal Investigator, nikhil.pawa@chelwest.nhs.uk
- Not yet recruiting
Imperial College Healthcare Nhs Trus
London, Greater London, W2 1BL
Principal Investigator, dominicblunt@nhs.net
- Not yet recruiting
Maidstone Hospital
Maidstone, KENT, ME16 9QQ
Principal Investigator, sukanyaghosh@nhs.net
- Not yet recruiting
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Principal Investigator, Chris.Cunningham@ouh.nhs.uk
- Not yet recruiting
Royal Berkshire Hospital
Reading, Berkshire, RG1 5AN
Principal Investigator, kum.nhs@googlemail.com
- Not yet recruiting
Salisbury District Hospital
Salisbury, Wiltshire, SP2 8BJ
Principal Investigator, Graham.Branagan@salisbury.nhs.uk
- Not yet recruiting
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
Principal Investigator, Nigel.D'souza@uhs.nhs.uk
- Not yet recruiting
Nhs Staffordshire and Stoke-on-Trent Integrated Care Board
Stafford, Staffordshire, ST16 2LP
Principal Investigator, Ingrid.britton@uhnm.nhs.uk
- Not yet recruiting
Tonna Hospital
Swansea, Wales, SA11 3LX
Principal Investigator, anil.ghosh@wales.nhs.uk
- Not yet recruiting
Croydon Health Services Nhs Trust
Thornton Heath, Surrey, CR7 7YE
Principal Investigator, annabel.shaw@nhs.net
- Not yet recruiting
St George'S Hospital
Tooting, London, SW17 0QT
Principal Investigator, Anita.Wale@stgeorges.nhs.uk
- Not yet recruiting
The Hillingdon Hospitals Nhs Foundation Trust
Uxbridge, Greater London, UB8 3NN
Principal Investigator, alistair.myers@nhs.net
About this study
When a patient is diagnosed with a rectal (bowel) polyp or cancer, radiology doctors read MRI scans to describe how deeply the cancer invades into the bowel wall (this is the 'stage' of the cancer). In this project, we will teach radiologists to find more early-stage rectal cancers. These are cancers that have only grown partially into the bowel wall. If we succeed, more patients could have these lesions removed by a local procedure that preserves the bowel and avoids the risks and complications of major surgery.
We have developed a new method for radiology doctors to read MRI scans, which is more accurate than current practice. Currently only 3/10 of early rectal cancers are found by radiologists but by using our MRI reading system, 9/10 patients can be accurately identified as having early rectal cancer. We have proven that we can teach this method to other radiology doctors whose reports help to accurately inform patients of all possible treatment options, so they can be offered the option of a local procedure.
In this initial work we will train radiology doctors in our MRI reading method in 20 hospitals. We will compare MRI reports before and after training to see if an accurate reading method improves treatments choices for patients. We will also determine whether more patients have local procedures after our training. The results of this initial work will help us to apply for national funding for a trial that we can quickly roll out to all NHS hospitals.
Read the detailed description
Many patients diagnosed with Early Rectal Cancer (ERC) are currently over-treated. Most patients with confirmed ERC will undergo an MRI, but some are not correctly identified in endoscopy and immediately removed. Of those who undergo MRI, 69% are over-staged and undergo major surgery or unnecessary radiotherapy when local excision surgery to preserve the patients rectum, and quality of life, would have been possible. <10% of patients with ERC are staged accurately and offered local excision, with the majority who are staged as ERC on MRI still undergoing major surgery, likely due to uncertainty in the staging report.
Prof Gina Brown developed a more accurate radiological staging system (PRESERVE) or ERC, whereby T2 tumours are identified and classified according to the degree of preservation of the individual layers of the rectal wall. It has been shown that PRESERVE enabled better identification of ERC suitable for local excision from the expected 30% to 89% accuracy. This improved accuracy was replicated in a further study by training a cohort of 12 radiologists. It is predicted that wider adoption of PRESERVE will result in increased organ-preserving surgery from the current rates of 10% to >50%.
- Conditions
- Rectal Cancer, Colo-rectal Cancer
- Being tested
- MRI scan, Radiologist training
- Keywords
- early stage, early phase, Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection, Histopathological Staging, MDT Decision Making, MRI Staging, Quality of Life, Radiotherapy, Rectal preservation, Shared decision making, Significant Rectal Polyps, Transanal Endoscopic Microsurgery, Transanal Minimally Invasive Surgery
- Medical subject headings
- Rectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanDiagnostic test
MRI scans will be recommended for all rectal polyps ≥20mm in size, or with other features suspicious of malignancy, prior to removal. This is designed to reduce the numbers of Early Rectal Cancers missed in endoscopy.
Radiologist trainingOther
Radiologist training in the use of the PRESERVE mrSRT for suspected Early Rectal Cancer.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm Schedule | No intervention | All sites will begin in the Control arm, with patients recruited to the Control Arm Schedule. Clinical investigations prior to treatment, during treatment, after surgery and during further treatment should be performed as per standard clinical practice and as clinically indicated. Each site will transition to the Intervention arm at a month prescribed by their randomised cluster, and from that point patients are recruited to the Intervention Arm Schedule . Patients will be recruited to either the Control or Intervention arms dependent on which arm is in progress at the site at the time of recruitment. There will be no crossover of patients between the arms at any point. |
| Intervention Arm Schedule | Experimental | Each site will transition to the Intervention arm at a month prescribed by their randomised cluster, and from that point patients are recruited to the Intervention Arm Schedule . The transition period lasts one month during which recruitment is halted and two interventions implemented:
1. MRI scans will be recommended for all rectal polyps ≥20mm in size, or with other features suspicious of malignancy, prior to removal. This is designed to reduce the numbers of Early Rectal Cancers missed in endoscopy.
2. Radiologist training in the use of the PRESERVE mrSRT for suspected Early Rectal Cancer.
Patients will be recruited to either the Control or Intervention arms dependent on which arm is in progress at the site at the time of recruitment. There will be no crossover of patients between the arms at any point. Receives: Diagnostic Test: MRI scan; Other: Radiologist training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of a training intervention on the accuracy of the tumour staging diagnosis through systematic reporting approach to MRI scans against current (pre intervention) practice.
Comparison of the proportion of patients with early rectal cancer who are diagnosed by pathology vs those staged as such by MRI, before and after the intervention.
Measured: 1 year
Secondary outcomes (18)
Proportion of patients with technically adequacate scans before and after intervention
Proportion of patients scanned with high resolution MR in the correct planes
Measured: 1 year
Proportion of primary tumour characterised by morphology and other features associated with malignancy before and after intervention
Proportion of reports where primary tumour has been characterised by morphology before and after intervention in i) endoscopy, ii) radiology reports before and after intervention
Measured: 1 year
Proportion of MRI reports with T substage given before and after intervention
Proportion of reports where T substage of primary tumour has been recorded before and after intervention
Measured: 1 year
Number of patients identified on imaging as suitable for rectal preservation by local excision
Proportion of imaging reports where suitable patients are identified on the report as suitable for rectal preservation by local excision being identified by the radiologist on the report before and after intervention
Measured: 1 year
Number of patients identified by MDT as suitable for rectal preservation by local excision
Proportion of MDT decisions where patients suitable for rectal preservation by local excision are identified and comparison of treatments offered to patients by the MDT, before and after the intervention
Measured: 1 year
Correlation of accuracy in the identification of safe plane of excision for rectal preservation by the radiologist
Proportion of patients with >1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients with >1mm submucosa preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients undergoing TME that have <1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention
Measured: 1 year
Numebr of patients with R0 by local excision or TME as appropriate
Proportion of patients with R0 that have >1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients with R0 that have>1mm submucosa preserved on histopathology identified as such by the radiologist before and after intervention Proportion of patients undergoing TME with R0 that have <1mm muscularis preserved on histopathology identified as such by the radiologist before and after intervention
Measured: 1 year
Qualitative EORTC QLQ-CR29 Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Comparison of QoL EORTC QLQ-CR29 scores before and after intervention. Questions relate to difficulty in performing every day tasks answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much'
Measured: 1 year, 3 years, 5 years
Qualitative EORTC QLQ-CR30 Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Comparison of QoL EORTC QLQ-CR30 scores before and after intervention. Questions relate to the presences of symptoms over the previous week answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much'
Measured: 1 year, 3 years, 5 years
Qualitative LARS Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Comparison of LARS scores before and after intervention. Questions relate to bowel function answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much'
Measured: 1 year, 3 years, 5 years
Qualitative Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Comparison of self evaluation of overall health and quality of life scores before and after intervention. Answers are rated from 1 very poor to 7 excellent
Measured: 1 year, 3 years, 5 years
Comparison of total costs of procedures performed between patients undergoing local excision surgery to those undergoing major surgery
Comparison of total costs of hospital procedures performed based on individual pathways before and after intervention
Measured: 1 year
Comparison of inpatient costs between patients undergoing local excision surgery to those undergoing major surgery
Comparison of cost of inpatient episodes based on individual pathways before and after intervention
Measured: 1 year
Comparison of total cost of outpatient visits between patients undergoing local excision surgery to those undergoing major surgery
Comparison of total cost of outpatient episodes based on individual pathways before and after intervention
Measured: 1 year
Comparison of total community costs between patients undergoing local excision surgery to those undergoing major surgery
Comparison of total cost of treatments delivered in the community based on individual pathways before and after intervention
Measured: 1 year
Number of patients without disease and/or without stoma between patients undergoing local excision surgery, compared to those undergoing major surgery
DFS and stoma free survival in patients based on individual pathways before and after intervention
Measured: 1 year, 3 years, 5 years
Assessment results for the effectiveness of mrSRT after a year from training
Determine longevity of training by assessment of radiologists trained with the PRESERVE mrSRT accuracy 1 year after training
Measured: 1 year
Identification of histopathological biomarkers to improve selection of patients who can undergo rectal preserving strategies for Early Recal Cancer
Comparison of relative % histopathological biomarkers screening panels between patients identified on imaging as suitable for rectal preservation by local excision being identified by the radiologist on the report before and after intervention
Measured: 2 months, 1 year, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multicentre, stepped-wedge cluster randomised trial. This pilot study will run for 9 months and utilise a stepped wedge cluster randomised controlled trial design (including transition period). Sites will enter data from the diagnostic and treatment pathways of all rectal cancer patients who are eligible for primary surgical treatment, eg those radiologically staged as less than or equal to T3b or with confirmed as less than or equal to pT2N0 pathological staging. Prior to the trial opening the participating sites will be randomly allocated a number, which will determine the number of months the site will remain in the control and then subsequently the intervention phase of the trial.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Pelican Cancer Foundation, RM Partners West London Cancer Alliance
- Responsible party
- Sponsor
- Investigators
- Gina Brown, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103372
- Sponsor's protocol ID
- DOCUMAS 24HH8769
- Acronym
- PRESERVE
- Status last verified
- Oct 2024
- First submitted
- 5 Sep 2019
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Detering R, van Oostendorp SE, Meyer VM, van Dieren S, Bos ACRK, Dekker JWT, Reerink O, van Waesberghe JHTM, Marijnen CAM, Moons LMG, Beets-Tan RGH, Hompes R, van Westreenen HL, Tanis PJ, Tuynman JB; Dutch ColoRectal Audit Group*. MRI cT1-2 rectal cancer staging accuracy: a population-based study. Br J Surg. 2020 Sep;107(10):1372-1382. doi: 10.1002/bjs.11590. Epub 2020 Apr 16.
PubMed 32297326Balyasnikova S, Read J, Wotherspoon A, Rasheed S, Tekkis P, Tait D, Cunningham D, Brown G. Diagnostic accuracy of high-resolution MRI as a method to predict potentially safe endoscopic and surgical planes in patients with early rectal cancer. BMJ Open Gastroenterol. 2017 Aug 14;4(1):e000151. doi: 10.1136/bmjgast-2017-000151. eCollection 2017.
PubMed 29259791
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-therapeutic MRI Assessment of Early-Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery
- ClinicalTrials.gov ID
- NCT04103372
- Acronym / sponsor ID
- PRESERVE / DOCUMAS 24HH8769
- Conditions
- Rectal Cancer, Colo-rectal Cancer
- Keywords
- early stage, early phase, Endoscopic Mucosal Resection, Endoscopic Submucosal Dissection, Histopathological Staging, MDT Decision Making, MRI Staging, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Pelican Cancer Foundation, RM Partners West London Cancer Alliance
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When a patient is diagnosed with a rectal (bowel) polyp or cancer, radiology doctors read MRI scans to describe how deeply the cancer invades into the bowel wall (this is the 'stage' of the cancer). In this project, we will teach radiologists to find more early-stage rectal cancers. These are cancers that have only grown partially into the bowel wall. If we succeed, more patients could have these lesions removed by a local procedure that preserves the bowel and avoids the risks and complications of major surgery.
We have developed a new method for radiology doctors to read MRI scans, which is more accurate than current practice. Currently only 3/10 of early rectal cancers are found by radiologists but by using our MRI reading system, 9/10 patients can be accurately identified as having early rectal cancer. We have proven that we can teach this method to other radiology doctors whose reports help to accurately inform patients of all possible treatment options, so they can be offered the option of a local procedure.
In this initial work we will train radiology doctors in our MRI reading method in 20 hospitals. We will compare MRI reports before and after training to see if an accurate reading method improves treatments choices for patients. We will also determine whether more patients have local procedures after our training. The results of this initial work will help us to apply for national funding for a trial that we can quickly roll out to all NHS hospitals.
Detailed description
Many patients diagnosed with Early Rectal Cancer (ERC) are currently over-treated. Most patients with confirmed ERC will undergo an MRI, but some are not correctly identified in endoscopy and immediately removed. Of those who undergo MRI, 69% are over-staged and undergo major surgery or unnecessary radiotherapy when local excision surgery to preserve the patients rectum, and quality of life, would have been possible. <10% of patients with ERC are staged accurately and offered local excision, with the majority who are staged as ERC on MRI still undergoing major surgery, likely due to uncertainty in the staging report.
Prof Gina Brown developed a more accurate radiological staging system (PRESERVE) or ERC, whereby T2 tumours are identified and classified according to the degree of preservation of the individual layers of the rectal wall. It has been shown that PRESERVE enabled better identification of ERC suitable for local excision from the expected 30% to 89% accuracy. This improved accuracy was replicated in a further study by training a cohort of 12 radiologists. It is predicted that wider adoption of PRESERVE will result in increased organ-preserving surgery from the current rates of 10% to >50%.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre, stepped-wedge cluster randomised trial. This pilot study will run for 9 months and utilise a stepped wedge cluster randomised controlled trial design (including transition period). Sites will enter data from the diagnostic and treatment pathways of all rectal cancer patients who are eligible for primary surgical treatment, eg those radiologically staged as less than or equal to T3b or with confirmed as less than or equal to pT2N0 pathological staging. Prior to the trial opening the participating sites will be randomly allocated a number, which will determine the number of months the site will remain in the control and then subsequently the intervention phase of the trial.
| Arm | Type | Receives |
|---|---|---|
| Control Arm Schedule | No intervention | –All sites will begin in the Control arm, with patients recruited to the Control Arm Schedule. Clinical investigations prior to treatment, during treatment, after surgery and during further treatment should be performed as per standard clinical practice and as clinically indicated. Each site will transition to the Intervention arm at a month prescribed by their randomised cluster, and from that point patients are recruited to the Intervention Arm Schedule . Patients will be recruited to either the Control or Intervention arms dependent on which arm is in progress at the site at the time of recruitment. There will be no crossover of patients between the arms at any point. |
| Intervention Arm Schedule | Experimental | Diagnostic Test: MRI scan, Other: Radiologist trainingEach site will transition to the Intervention arm at a month prescribed by their randomised cluster, and from that point patients are recruited to the Intervention Arm Schedule . The transition period lasts one month during which recruitment is halted and two interventions implemented: 1. MRI scans will be recommended for all rectal polyps ≥20mm in size, or with other features suspicious of malignancy, prior to removal. This is designed to reduce the numbers of Early Rectal Cancers missed in endoscopy. 2. Radiologist training in the use of the PRESERVE mrSRT for suspected Early Rectal Cancer. Patients will be recruited to either the Control or Intervention arms dependent on which arm is in progress at the site at the time of recruitment. There will be no crossover of patients between the arms at any point. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Have a rectal tumour or suspected tumour less than or equal to T3b on MRI stage or pT2 or less after excision, or 20mm or more on endoscopy with suspicion of malignancy
- Be aged 16 years or over
Key exclusion criteria (3 listed)
- Have metastatic disease at time of initial staging
- Have a biopsy-proven rectal malignancy which is not adenocarcinoma
- Are contraindicated for MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scanMRI scans will be recommended for all rectal polyps ≥20mm in size, or with other features suspicious of malignancy, prior to removal. This is designed to reduce the numbers of Early Rectal Cancers missed in endoscopy. | Diagnostic test | Intervention Arm Schedule |
| Radiologist trainingRadiologist training in the use of the PRESERVE mrSRT for suspected Early Rectal Cancer. | Other | Intervention Arm Schedule |
Primary outcome
Impact of a training intervention on the accuracy of the tumour staging diagnosis through systematic reporting approach to MRI scans against current (pre intervention) practice.
Time frame: 1 year
Comparison of the proportion of patients with early rectal cancer who are diagnosed by pathology vs those staged as such by MRI, before and after the intervention.
18 secondary outcomes
Proportion of patients with technically adequacate scans before and after intervention
Time frame: 1 year
Proportion of primary tumour characterised by morphology and other features associated with malignancy before and after intervention
Time frame: 1 year
Proportion of MRI reports with T substage given before and after intervention
Time frame: 1 year
Number of patients identified on imaging as suitable for rectal preservation by local excision
Time frame: 1 year
Number of patients identified by MDT as suitable for rectal preservation by local excision
Time frame: 1 year
Correlation of accuracy in the identification of safe plane of excision for rectal preservation by the radiologist
Time frame: 1 year
Numebr of patients with R0 by local excision or TME as appropriate
Time frame: 1 year
Qualitative EORTC QLQ-CR29 Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Time frame: 1 year, 3 years, 5 years
Qualitative EORTC QLQ-CR30 Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Time frame: 1 year, 3 years, 5 years
Qualitative LARS Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Time frame: 1 year, 3 years, 5 years
Qualitative Questionnaire on Quality of Life of patients undergoing local excision vs major surgery
Time frame: 1 year, 3 years, 5 years
Comparison of total costs of procedures performed between patients undergoing local excision surgery to those undergoing major surgery
Time frame: 1 year
Comparison of inpatient costs between patients undergoing local excision surgery to those undergoing major surgery
Time frame: 1 year
Comparison of total cost of outpatient visits between patients undergoing local excision surgery to those undergoing major surgery
Time frame: 1 year
Comparison of total community costs between patients undergoing local excision surgery to those undergoing major surgery
Time frame: 1 year
Number of patients without disease and/or without stoma between patients undergoing local excision surgery, compared to those undergoing major surgery
Time frame: 1 year, 3 years, 5 years
Assessment results for the effectiveness of mrSRT after a year from training
Time frame: 1 year
Identification of histopathological biomarkers to improve selection of patients who can undergo rectal preserving strategies for Early Recal Cancer
Time frame: 2 months, 1 year, 3 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Background: PubMed 32297326Detering R, van Oostendorp SE, Meyer VM, van Dieren S, Bos ACRK, Dekker JWT, Reerink O, van Waesberghe JHTM, Marijnen CAM, Moons LMG, Beets-Tan RGH, Hompes R, van Westreenen HL, Tanis PJ, Tuynman JB; Dutch ColoRectal Audit Group*. MRI cT1-2 rectal cancer staging accuracy: a population-based study. Br J Surg. 2020 Sep;107(10):1372-1382. doi: 10.1002/bjs.11590. Epub 2020 Apr 16.
- Background: PubMed 29259791Balyasnikova S, Read J, Wotherspoon A, Rasheed S, Tekkis P, Tait D, Cunningham D, Brown G. Diagnostic accuracy of high-resolution MRI as a method to predict potentially safe endoscopic and surgical planes in patients with early rectal cancer. BMJ Open Gastroenterol. 2017 Aug 14;4(1):e000151. doi: 10.1136/bmjgast-2017-000151. eCollection 2017.
- National Bowel Cancer Audit. Annual Report 2022 \[Internet\]. Leeds: NBOCA; 2022Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gina Brown, MD principal investigator
Imperial College London
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan and Radiologist training in people with Rectal Cancer and Colo-rectal Cancer, run by Imperial College London at 23 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Martin (+44 (0) 7749 655 817, c.martin1@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of a training intervention on the accuracy of the tumour staging diagnosis through systematic reporting approach to MRI scans against current (pre intervention) practice. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04103372, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.