Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-17 @ 6:50 PM
Study NCT ID:
NCT02328066
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2014-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion
Sponsor:
Asociación Española de Gastroenterología
Organization:
Study Overview
Official Title:
Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion in Colon Lesions. Prospective Multicenter Study in Routine Clinical Practice
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NICE
Brief Summary:
The purpose of this study is to evaluate the diagnostic accuracy of NICE classification to predict deep submucosal invasion of colonic polyps \> 1 cm, considering histology as the gold standard, in a group of endoscopists who previously performed a training program.
Detailed Description:
In the first phase of the study, a learning program of NICE classification based on examples will be performed. Forty images will be evaluated before and after the learning program.
In the second phase of the study, all consecutive patients who underwent to a colonoscopy will be included if a lesion greater than 1 cm is found and the endoscopy is performed with a high definition colonoscope with Narrow Band Imaging (NBI). Patients, lesions and endoscopy equipment characteristics will be recorded.
Subsequently, histological diagnosis of the lesion will also be recorded. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology). In case of adenocarcinomas, histological predictors of lymph node metastases, with predefined assessment criteria, will also be recorded.
Finally, histological preparations of adenocarcinomas will be sent to the reference center and two experienced pathologists will examine them again.
In the second phase of the study, all consecutive patients who underwent to a colonoscopy will be included if a lesion greater than 1 cm is found and the endoscopy is performed with a high definition colonoscope with Narrow Band Imaging (NBI). Patients, lesions and endoscopy equipment characteristics will be recorded.
Subsequently, histological diagnosis of the lesion will also be recorded. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology). In case of adenocarcinomas, histological predictors of lymph node metastases, with predefined assessment criteria, will also be recorded.
Finally, histological preparations of adenocarcinomas will be sent to the reference center and two experienced pathologists will examine them again.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: