Improving diagnosis and treatment for patients with rectal cancer
| ISRCTN | ISRCTN13624517 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13624517 |
| IRAS number | 348532 |
| Secondary identifying numbers | CPMS 64773 |
- Submission date
- 29/05/2025
- Registration date
- 16/06/2025
- Last edited
- 01/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The purpose of staging is to provide a prognosis of the cancer, namely the risk to the patient’s life and the risk of cancer returning.
The cancer stage information from scans guides pre-operative treatment and the type of surgery offered. We are studying whether a new Magnetic Resonance Imaging (MRI) staging method can improve the accuracy of prognosis for patients diagnosed with rectal cancer.
Who can participate?
All adult patients aged 16 years and over who have been diagnosed with rectal cancer
What does the study involve?
We will collect information about your diagnostic tests and treatment. We will ask you to share your experiences by filling in questionnaires at intervals during your patient journey and treatment when you visit the hospital for your doctor’s appointments.
What are the possible benefits and risks of participating?
There are no disadvantages to taking part. You will continue to receive standard care, as guided by your local doctors, throughout the trial. We hope that the information from this trial will help us improve the way we classify rectal cancer in future and provide a better understanding of how treatments for rectal cancer impact on patient’s lives. This could benefit other patients with the same condition as you in the future. There will be no direct benefit.
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
June 2025 to May 2031
Who is funding the study?
NHS England through RM Partners and Pelican Cancer Foundation
Who is the main contact?
Caroline Martin, giclinicaltrials@imperial.ac.uk
Plain English summary under review with external organisation
Contact information
Imperial College London
Room BN1/2 | 1st Floor, Block B
Hammersmith Hospital Campus
Du Cane Road
London
W12 0NN
United Kingdom
| c.martin1@imperial.ac.uk |
Imperial College London
Room BN1/2
1st Floor Block B
Hammersmith Hospital Campus
Du Cane Road
London
W12 0NN
United Kingdom
 ORCID ID |
0000-0002-2336-622X |
|---|---|
| Phone | +44 (0)7917302097 |
| gina.brown@imperial.ac.uk |
Study information
| Study design | Non-randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Improving the prognostic accuracy of staging rectal cancer using magnetic resonance imaging (MRI) - detected tumour deposits and vascular invasion (mrTDV) instead of tumour nodal metastasis (mrTNM) |
| Study acronym | MERCURY 3 |
| Study objectives | A different staging system that assesses tumour deposits (TDs) and tumour spread into veins (mrTDV) will improve the quality of care of patients diagnosed with rectal cancer compared with the current practice of using tumour nodal metastasis (mrTNM). |
| Ethics approval(s) | Approved 28/05/2025, East Midlands - Derby Research Ethics Committee (2 Redman Place, London, EC20 1JQ, UK; +44 (0)207 104 8154, +44 (0)207 104 8283, +44 (0)207 104 8146; derby.rec@hra.nhs.uk), ref: 25/EM/0105 |
| Health condition(s) or problem(s) studied | Rectal cancer |
| Intervention | The training of radiologists to implement specialised MRI reporting using the TDV staging system. Patients in the study will be recruited in two phases: control and intervention. All eligible patients will be identified in the multidisciplinary meetings and will be registered on the trial. Patients will undergo their normal treatment as determined by their clinical team. For 6 months before training of the radiologists (this is the intervention), scan reports will be captured and compared with histopathology. All scans performed in 2019 will also be captured and compared with histopathology. The results from both these sets of data will be shown to the radiologists as part of their training and discussed with the MDT. Scan reports will then be captured and compared with histopathology for 6 months after the training of the radiologists to compare. Long-term outcomes before and after the intervention will be compared. In addition, clinical team members will approach patients to consent for quality of life and the shared decision-making process. The patient information sheet explains that we are providing consultant radiologists with the know-how to report MRI scans using a new method and comparing it with the existing method. We explain that this study will test this by comparing how accurately the old vs new method predicts the outcomes for patients. The clinical team will follow up with the patients for 5 years at 1, 3 and 5 years to report on their long-term outcomes. Consented patients will also be asked to complete a quality of life questionnaire at their routine clinical follow-up appointments. They will not attend clinic for any research-specific reason. Research staff will capture the number and type of hospital visits and investigations for patients in both the control and intervention phases at one year. This is to compare health resource use between the phases. This data is non-clinical observations about NHS resource use. |
| Intervention type | Other |
| Primary outcome measure | Survival for mrTNM and mrTDV before and after the intervention (at 1 and 5 years) |
| Secondary outcome measures | 1. Agreement between radiologists in mrTDV staging vs mrTNM: agreement in prognostic accuracy between radiology and histopathology using TNM versus TDV at 1 and 5 years 2. mrTDV and TNM compared with respective histopathology staging for prognosis: agreement in prognostic accuracy between radiology and histopathology using TNM versus TDV at 1 and 5 years 3. Impact of the introduction of mrTDV staging on MDT decision-making: MDT treatment policies before and after mrTDV intervention at 1 and 5 years 4. Changes in treatment strategy following MRI-TDV staging intervention: treatments given before and after mrTDV intervention at 6 months and 1 year 5. Oncological outcomes for mrTNM versus TDV: disease-free survival (DFS) and local recurrence rates before and after mrTDV intervention at 1 and 5 years 6. Quality of life measured using Qualitative EORTC QLQ-CR29 Questionnaire at 6 months, 1 and 5 years 7. Quality of life measured using Qualitative EORTC QLQ-CR30 Questionnaire at 6 months, 1 and 5 years 8. Bowel function measured using Low Anterior Resection Syndrome (LARS) score at 6 months, 1 and 5 years 9. Patient shared decision making (SDM) measured using SM-Q9 scores at 6 months, 1 and 5 years 10. Validation of an educational programme for radiologists and MDTs to improve MRI reporting with TDV staging: assessment of radiologists' prognostic accuracy and agreement using TNM versus TDV at 6 months and 1 year 12. Comparison of inpatient costs between patients before and after intervention: comparison of relative % histopathological biomarkers screening panels between patients identified by the radiologist on the report before and after intervention at 18 and 36 months 13. Comparison of total cost of outpatient visits between patients based on individual pathways before and after intervention at 18 and 30 months 14. Number of patients without disease and/or without stoma before and after intervention: DFS and stoma-free survival in patients based on individual pathways before and after intervention at 18 and 30 months 15. Assessment of novel and existing histopathological biomarkers to improve prognostic and predictive markers: comparison of relative % histopathological biomarkers screening panels between patients identified by the radiologist on the report before and after intervention at 6, 12, 18 months and 3 and 5 years |
| Overall study start date | 01/06/2025 |
| Completion date | 31/05/2031 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 438; UK Sample Size: 438 |
| Key inclusion criteria | 1. Have a rectal cancer proven on biopsy or subsequent surgery 2. Sites able to submit anonymised MRI staging scans, pathology and imaging reports for central review 3. Aged 16 years or over |
| Key exclusion criteria | 1. Have irresectable metastatic disease at time of initial staging 2. Undergoing palliative treatment for rectal cancer 3. Have a biopsy-proven rectal malignancy which is not adenocarcinoma 4. Are contraindicated for MRI staging |
| Date of first enrolment | 01/06/2025 |
| Date of final enrolment | 31/05/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Warrington
WA2 8DB
United Kingdom
Calow
Chesterfield
S44 5BL
United Kingdom
Sutton-in-ashfield
NG17 4JL
United Kingdom
Harlow
CM20 1QX
United Kingdom
Taunton
TA1 5DA
United Kingdom
London
E1 2ES
United Kingdom
Redhill
RH1 5RH
United Kingdom
Worthing
BN11 2DH
United Kingdom
2 Eday Road
Aberdeen
AB15 6RE
United Kingdom
Camberley
GU16 7UJ
United Kingdom
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
York
YO31 8HE
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
Sponsor information
University/education
South Kensington Campus
Level 5, Sherfield Building
London
SW7 2AZ
England
United Kingdom
| Phone | +44 (0)20 7594 9459 |
|---|---|
| becky.ward@imperial.ac.uk | |
| Website | https://www.imperial.ac.uk |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof. Gina Brown (gina.brown@imperial.ac.uk) |
Editorial Notes
01/07/2025: Northwick Park Hospital, St Marys Hospital, Chesterfield Royal Hospital, Kings Mill Hospital, The Princess Alexandra Hospital, Musgrove Park Hospital, The Royal London Hospital, East Surrey Hospital, Worthing Hospital, Health Protection Team (NHS Grampian), Frimley Park Hospital, Southmead Hospital, York District Hospital, and Basingstoke and North Hampshire Hospital were added to the study participating centres.
30/05/2025: Study's existence confirmed by the NIHR.
