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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 438
- 试验地点
- 3
- 主要终点
- Validate that mrTDV staging can predict prognosis more accurately than mrTNM.
研究概览
简要总结
The cancer stage information from scans guides pre-operative treatment and the type of surgery offered. The investigators are studying whether a new Magnetic Resonance Imaging (MRI) staging method can improve the accuracy of prognosis for patients diagnosed with rectal cancer. The investigators will provide consultant radiologists with the know-how to report MRI scans using this new method and compare this with the existing method. This study will test this by comparing how accurately the old versus new method predict the outcomes of patients. The existing method relies on radiologists determining if tumour has spread through the bowel wall or not and whether there are suspected malignant lymph nodes. The new method looks for tumour spread into the veins and whether or not there are tumour deposits. Our previous research has shown that the new method is much more accurate at predicting prognosis, but this finding needs to be verified by a larger multicentre study.
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.
详细描述
A Retrospective and Prospective Cohort study to improve the prognostic accuracy of preoperative staging in patients diagnosed with primary rectal cancer. The intervention is the training of radiologists to implement specialised MRI reporting using the TDV staging system.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a rectal cancer proven on biopsy or subsequent surgery
- •Sites able to submit anonymised MRI staging scans, pathology and imaging reports for central review
- •Aged 16 years or over
排除标准
- •Have irresectable metastatic disease at time of initial staging
- •Undergoing palliative treatment for Rectal Cancer
- •Have a biopsy-proven rectal malignancy which is not adenocarcinoma
- •Are contraindicated for MRI staging
研究组 & 干预措施
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.
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.
干预措施: mrTDV (Other)
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.
结局指标
主要结局
Validate that mrTDV staging can predict prognosis more accurately than mrTNM.
时间窗: 1 and 5 years
Survival differences for mrTNM and mrTDV before and after intervention will be compared
次要结局
- Report changes in numbers of treatments offered following MRI-TDV staging intervention(6 months and 1 year)
- Assessment of novel and existing histopathological biomarkers to improve prognostic and predictive markers(6, 12, 18 months and 3, 5 years)
- Assess the degree of agreement between radiologists using mrTDV method of staging rectal cancer vs mrTNM method of staging rectal cancer.(1 and 5 years)
- Compare percentage agreement when staging of tumours using mrTDV method of staging rectal cancer and TNM method of staging rectal cancer with respective histopathology staging for prognosis.(1 and 5 years)
- Measure the introduction of mrTDV staging and its impact on MDT decision-making with regards to treatment decisions(1 and 5 years)
- Report differences in disease free survival outcomes for rectal cancers staged using mrTNM method of staging versus TDV method of staging(1 and 5 years)
- Report differences in local recurrence rates for rectal cancers staged using mrTNM method of staging versus TDV method of staging(1 and 5 years)
- Qualitative EORTC QLQ-CR29 Questionnaire on Quality of Life of patients before and after adoption of mrTDV staging(6 months, 1 and 5 years)
- Qualitative EORTC QLQ-CR30 Questionnaire on Quality of Life of patients before and after adoption of mrTDV staging(6 months, 1 and 5 years)
- Report differences in patient LARS scores before and after adoption of mrTDV staging(6 months, 1 and 5 years)
- Report differences in patient shared decision making (SDM) before and after adoption of mrTDV staging(6 months, 1 and 5 years)
- Validate an educational programme for radiologists and MDTs to improve MRI reporting with TDV staging.(6 months and 1 year)
- Comparison of inpatient costs between patients before and after intervention(18 and 36 months)
- Comparison of total cost of outpatient visits between patients before and after intervention(18 and 30 months)
- Number of patients without disease and/or without stoma before and after intervention(18 and 30 months)