Rectal cancer Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival for mrTNM and mrTDV before and after the intervention (at 1 and 5 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 p | — |
Countries
England, United Kingdom