Improving Diagnosis and Treatment for Patients With Rectal Cancer
NCT ID: NCT07054047
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
438 participants
INTERVENTIONAL
2025-07-01
2031-05-31
Brief Summary
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The investigators are also studying the patient journey, so the investigators can better understand patients' experiences and the impact that treatments have on their quality of life. The investigators wish to understand if improvements in the accuracy of prognosis from scans could change treatment decisions in future. The investigators will also compare the radiology scan prediction of prognostic factors by looking carefully at the tumour specimens.
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Detailed Description
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The investigators will collect anonymized scans, clinical and histopathology data from all rectal cancer patients diagnosed in 2019. The central reviewing radiologist will stage the scans by a) mrTDV and b) mrTNM into poor and good prognosis categories. The investigators will compare survival outcomes from original reports as well as the two staging systems using Kaplan-Meier and Cox Proportional-Hazard methods.
The investigators will compare prospectively collected data before and after implementation of the consensus for identifying and treating high-risk and low-risk rectal cancers. The investigators will report on the comparisons of staging, histopathology, MDT treatment decisions, resource utilisation, how patients experienced information provided for shared decision making before and after the intervention changes and quality of life measures.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
Pre-intervention - local MDT decisions based on current MRI reporting practices will be collected for six months.
Intervention - local radiologists will be trained to recognize features of mrTDV and use a standardised reporting template. We will present the retrospective and radiologists' cohort results to MDT stakeholders who will agree the optimum stage based preoperative treatment decision making policy. We will offer training as required using the 2019 retrospective cohort.
Post-intervention - local MDT decisions based on the consensus optimum stage based preoperative decision-making policy will be collected for six months.
DIAGNOSTIC
NONE
Study Groups
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Control Arm Schedule
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 remain in the Control Arm Schedule for six months. There will be a transition month with no recruitment where training is undertaken. After the transition month 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.
No interventions assigned to this group
Intervention Arm Schedule
During the transition month, all Radiologists involved in reporting rectal cancers for the MDT will be offered training in reporting of mrTDV. Results of the retrospective data analysis will be shared at the MDT teams stakeholder meeting to determine their optimum stage based preoperative treatment decision making policy. Every site will remain in the Intervention Arm Schedule for six months.
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.
mrTDV
The training of radiologists to implement specialised MRI reporting using the TDV staging system
Retrospective cohort
Registration of all rectal cancer patients staged as non-metastatic in their site pre-treatment MDT from 1st January 2019 - 31st December 2019 should commence as soon as the site is issued the green light. The analysis of this data will be presented to their site MDT six months from the green light. Therefore, every effort should be made to complete the 2019 retrospective cohort registrations within the first three months of the trial start. We anticipate the average number of 2019 retrospective cohort patients treated for rectal cancer will be 20 per site.
No interventions assigned to this group
Interventions
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mrTDV
The training of radiologists to implement specialised MRI reporting using the TDV staging system
Eligibility Criteria
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Inclusion Criteria
2. Sites able to submit anonymised MRI staging scans, pathology and imaging reports for central review
3. Aged 16 years or over
Exclusion Criteria
2. Undergoing palliative treatment for Rectal Cancer
3. Have a biopsy-proven rectal malignancy which is not adenocarcinoma
4. Are contraindicated for MRI staging
16 Years
99 Years
ALL
No
Sponsors
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NHS England
OTHER_GOV
Pelican Cancer Foundation
OTHER
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Gina Brown, MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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Southampton General Hospital
Southampton, Hampshire, United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom
Salisbury District Hospital
Salisbury, Wiltshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Morris EJA, Finan PJ, Spencer K, Geh I, Crellin A, Quirke P, Thomas JD, Lawton S, Adams R, Sebag-Montefiore D. Wide Variation in the Use of Radiotherapy in the Management of Surgically Treated Rectal Cancer Across the English National Health Service. Clin Oncol (R Coll Radiol). 2016 Aug;28(8):522-531. doi: 10.1016/j.clon.2016.02.002. Epub 2016 Feb 28.
Wilkinson E. NICE withdraws quality standard on colorectal cancer treatment after "lack of consensus". Lancet Oncol. 2022 Mar;23(3):333. doi: 10.1016/S1470-2045(22)00084-5. Epub 2022 Feb 10. No abstract available.
Lord AC, D'Souza N, Shaw A, Rokan Z, Moran B, Abulafi M, Rasheed S, Chandramohan A, Corr A, Chau I, Brown G. MRI-Diagnosed Tumor Deposits and EMVI Status Have Superior Prognostic Accuracy to Current Clinical TNM Staging in Rectal Cancer. Ann Surg. 2022 Aug 1;276(2):334-344. doi: 10.1097/SLA.0000000000004499. Epub 2020 Sep 15.
Lord AC, Corr A, Chandramohan A, Hodges N, Pring E, Airo-Farulla C, Moran B, Jenkins JT, Di Fabio F, Brown G. Assessment of the 2020 NICE criteria for preoperative radiotherapy in patients with rectal cancer treated by surgery alone in comparison with proven MRI prognostic factors: a retrospective cohort study. Lancet Oncol. 2022 Jun;23(6):793-801. doi: 10.1016/S1470-2045(22)00214-5. Epub 2022 May 2.
Other Identifiers
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348532
Identifier Type: OTHER
Identifier Source: secondary_id
25/EM/0105
Identifier Type: OTHER
Identifier Source: secondary_id
EDGE: 176847
Identifier Type: -
Identifier Source: org_study_id
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