跳至主要内容
临床试验/NCT05983315
NCT05983315已完成不适用

Prospective Assessment of CONECCT's Classification for Histological Predictive Diagnostic Value in Conducting Therapeutic Choice for Colorectal Lesions. Pro-CONECCT

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
750
试验地点
1
主要终点
Correlation between endoscopic CONECCT's classification

研究概览

简要总结

Colorectal neoplastic lesion endoscopic characterization is a key element for histological predictive diagnostic value in conducting best appropriate resection choice. Six classifications are necessary for fully correct characterization of different colorectal lesions. Nonetheless, it can be tricky to use so many diagnostic tools with so many subcategories in the 6 existing classifications. That's why we decided to integrate all 6 existing classification validated factors in one single chart (CONECCT chart) allowing to both predict histological diagnostic value and to propose the best appropriate resection strategy. A previous prospective and multicentre study with all French medical residents in gastroenterology was conducted in order to prove pedagogic interest of this diagnostic tool. Each student was asked to review 20 files with lesion pictures before and after lecture about CONECCT chart. This allowed us to prove that this diagnostic tool could significantly improve both histological predictive diagnostic value and therapeutic choice by French medical residents and gastroenterologists. Our hypothesis is that CONECCT's classification can improve predictive diagnostic value of colorectal lesions in over 80% of cases. Now that pedagogic interest of this diagnostic tool has been proven, we would like to carry out a larger prospective assessment in term of performance (value) of this instrument in order to both facilitate endoscopic characterization and allow a most appropriate diagnostic and therapeutic management of each colorectal lesion category.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlation between endoscopic CONECCT's classification

时间窗: Time point can be reached either 2 weeks after endoscopic resection at V1 or between 2-4 months later in case of surgery at V3

assessed by one of research site operators and final histology reading of neoplastic lesion by anatomopathologist: * CONECCT 0E : neuroendocrine tumor * CONECCT IH : hyperplastic polyp * CONECCT IS : sessile serrated lesion with or without dysplasia * CONECCT IIA : low or high grade adenoma * CONECCT IIC : low or high grade adenoma or intramucosal or submucosal \<1000 micron adenocarcinoma * CONECCT III : deep invasive submucosal \> 1000 microns adenocarcinoma

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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