Clinical Trials Logo

Clinical Trial Summary

This study has three main purposes:screening: the first purpose is to evaluate the diagnostic value of combintion of the life risk factors and immunochemical fecal occult blood test (FIT) on detection of colorectal neoplasia in Chinese population; resection: the second objective is to investigate the complete resection rate of colorectal adenoma and risk factors of incomplete resection in China; identification and classification: the third objective is to initially establish an artificial intelegence-assissted recognition and classification system of polyp based on deep learning.


Clinical Trial Description

This study is a multi-center cross-sectional survey and diagnostic test led by the National Clinical Research Center for Digestive Disease (Shanghai) (Department of Gastroenterology, Changhai Hospital, Naval Medical University), which is conducted at about 175 digestive endoscopy centers nationwide in China, with the expectation of including 12,000 patients (10,000 screenig and 2,000 adenoma resection). The basic characteristics of patients, bowel preparation method and quality, and related information of colonoscopy are recorded in detail. According to the research purpose, the whole project can be divided into three sections. 1. Screening section: All patients receive FIT test and colonoscopy, whose age, sex, family history, smoking history, body mass index (BMI), diabetes and other risk factors are collected by researchers through pad, equipped with a specially designed database and app. Using colonoscopy results as the gold standard, the risk prediction model for the Chinese population is explored, and the optimal strategy of colonoscopy practice for the Chinese established initially. 2. Resection section: During the polypectomy, for all pathologically confirmed or NBI-predicted adenomas with size<10mm, 1-2 biopsies were randomly performed on the edge after resection to determine the completion rate of the polypectomy. 3. Identification and classification section: For Patients regardless of cancer diagnosis or polypectomy, if there is polyp, observation of narrow band imaging (NBI) with or without magnification is required, with 4 white light and NBI images collected and reserved, respectively. If there is magnifying endoscopy, another 4 endoscopic images of magnification are also required. Endoscopists are invited to predict the pathology of polyps according to the NBI International Colorectal Endoscopic (NICE) classification principle and endoscopic images, and upload the pathological results and endoscopic images within 2-4 week after colonoscopy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03712059
Study type Observational
Source Changhai Hospital
Contact
Status Completed
Phase
Start date November 1, 2018
Completion date September 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT04192565 - A Prospective Investigation of the ColubrisMX ELS System N/A
Completed NCT04516785 - Reducing Colonoscopies in Patients Without Significant Bowel Disease
Not yet recruiting NCT05776381 - The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp Phase 2
Recruiting NCT06040632 - IMPROVE-pT1: Accurate Allocation of Completion Resection in Early Colorectal Cancer
Recruiting NCT05660317 - Assessment of Endoscopic Tip Control Using a Novel Score Based on the Snare Tip Soft Coagulation of Polypectomy Margin Defects
Withdrawn NCT05606081 - Predicting Risk for Post-polypectomy Colorectal Cancer N/A
Recruiting NCT05576506 - Application of Hyperspectral Imaging Analysis Technology in the Diagnosis of Colorectal Cancer Based on Colonoscopic Biopsy
Not yet recruiting NCT05545189 - Polyp Histology Prediction by Artificial Intelligence
Recruiting NCT06032104 - Feasibility and Colorectal Benefits of Pulses Supplementation N/A
Completed NCT05477836 - Feasibility and Safety of MiWEndo-assisted Colonoscopy N/A
Completed NCT04111601 - BLI Based Adenoma Surveillance Strategy
Completed NCT03822390 - Diagnostic Performance of a Convolutional Neural Network for Diminutive Colorectal Polyp Recognition
Recruiting NCT05545787 - Cold or Hot Snare Endoscopic Mucosal Resection for 10-19mm Non-pedunculated Colorectal Polyps N/A
Recruiting NCT04149184 - Computer-aided Detection Device in Standard Colonoscopy N/A
Recruiting NCT03359343 - Computer-assisted Diagnosis System Based on Linked Colour Imaging N/A
Completed NCT04349787 - Improving Optical Diagnosis of Colorectal Polyps Using CADx and BASIC.
Not yet recruiting NCT05041478 - Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC) N/A
Active, not recruiting NCT05846295 - Online Education Module to Accurately Classify Polyp Size N/A
Recruiting NCT06447012 - Artificial Intelligence Development for Colorectal Polyp Diagnosis
Recruiting NCT04407416 - VOCs vs FIT for Colorectal Cancer Screening N/A