Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест MRI mapping to guide pathological sampling of extranodal tumour deposits
  Radiologist to mark areas where extranodal disease is identified on MRI. The pathologist will use this to take additional samples for analysis. This will allow better pathological staging and will affect treatment decisions for patients.

Первичные конечные точки

• To determine whether the prevalence of TD on pathology is found to be higher if imaging mapping is used. [Срок оценки: Up to 2 years]

Вторичные конечные точки (8)

• To determine whether lesions classified as TD on Imaging correspond to the pathological diagnosis of TD. [Срок оценки: Up to 2 years]
• 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. [Срок оценки: 1, 3 and 5 years]
• To investigate features of the primary tumour compared with tumour deposits [Срок оценки: Up to 2 years and up to 5 years follow up]
• To investigate features of the primary tumour compared with lymph nodes [Срок оценки: 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 and attempt to refine and clarify the definitions used in pathology. [Срок оценки: Up to 2 years]
• To objectively record the features seen which help distinguish a LN from an TD [Срок оценки: Up to 2 years]
• To assess inter-observer agreement between the local pathologist and the central reviewing pathologist. [Срок оценки: Up to 2 years0]
• To assess inter-observer agreement between the local radiologist and central reviewing radiologist. [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Patients with recurrent tumours
• Synchronous tumours
• Under the age of 16 years
• Unable to give informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Royal Marsden Hospital NHS Foundation Trust — London

Публикации

• Lord AC, Moran B, Abulafi M, Rasheed S, Nagtegaal ID, Terlizzo M, Brown G. Can extranodal tumour deposits be diagnosed on MRI? Protocol for a multicentre clinical trial (the COMET trial). BMJ Open. 2020 Oct 7;10(10):e033395. doi: 10.1136/bmjopen-2019-033395. PMID 33033006

Идентификаторы

NCT: NCT03303547 · DOCUMAS: 23HH8158

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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