Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To determine whether the prevalence of TD on pathology is found to be higher if imaging mapping is used.
研究概览
简要总结
Any patient with a suspected primary adenocarcinoma of the colon, sigmoid or rectum undergoing surgery are eligible. The date of surgery must be known prior to registration. This trial aims to determine if image mapping techniques can improve the concordance between imaging and pathology detection of tumour deposits. Lymph nodes and tumour deposits will be identified on pre-operative scans and mapped by radiologists then shared with pathologists prior to processing the resected specimen. Patients will be managed at their local hospital with standard follow-up. Patients will be followed up for 5 years.
详细描述
A prospective interventional multi-centre study, COMET aims to prove the accuracy of imaging diagnosis of extranodal tumour deposits (TD) and their adverse effect on prognosis of colorectal cancers. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected primary adenocarcinoma of the colon, sigmoid or rectum (proven by biopsy taken as part of routine clinical practice, patients to be withdrawn if not subsequently adenocarcinoma on pathology).
- •Amenable to surgical resection.
- •Disease spread assessed on imaging
- •Patients having primary surgery and those undergoing neoadjuvant treatment will be included.
- •All must have had baseline staging scans and those undergoing neoadjuvant therapy must also have had a post-treatment scan.
- •Patients aged 16 years and over
排除标准
- •Patients with recurrent tumours
- •Synchronous tumours
- •Under the age of 16 years
- •Unable to give informed consent.
结局指标
主要结局
To determine whether the prevalence of TD on pathology is found to be higher if imaging mapping is used.
时间窗: Up to 2 years
Comparison of the proportion of patients with TD on imaging with proportion of patients with TD on histopathology defined as 'nodules without definite features of lymph node architecture'
次要结局
- To objectively record the features seen which help distinguish a LN from an TD and attempt to refine and clarify the definitions used in pathology.(Up to 2 years)
- To assess inter-observer agreement between the local radiologist and central reviewing radiologist.(Up to 2 years)
- To determine whether lesions classified as TD on Imaging correspond to the pathological diagnosis of TD.(Up to 2 years)
- To investigate features of the primary tumour compared with tumour deposits(Up to 2 years and up to 5 years follow up)
- To determine the effect of Imaging and pathological diagnosis of TD on disease free survival (at one, three and five years), overall survival (at one, three and five years) and time to local recurrence.(1, 3 and 5 years)
- To investigate features of the primary tumour compared with lymph nodes(Up to 2 years and up to 5 years follow up)
- To objectively record the features seen which help distinguish a LN from an TD(Up to 2 years)
- To assess inter-observer agreement between the local pathologist and the central reviewing pathologist.(Up to 2 years0)