European Serrated Adenoma Classification Score

Colorectal Neoplasms Clinical Trial

— ESCO  

Official title:

Development of an Endoscopic Classification Score System for Serrated Adenomas in the Colorectum

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03486418
• Other study ID #: ESCO
• Status: Active, not recruiting
• Start date: April 1, 2018
• Est. completion date: April 2021

Study information

• Verified date: September 2020
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to develop a score system in order to differentiate adenomatous polyps, hyperplastic polyps and serrated adenomas on the basis of optical features. Endoscopic images of colorectal polyps will be collected from a prospectively managed database. Histopathological diagnoses are available for all polyps. Histopathological diagnoses serve as gold standard in this study.

In the first phase of the study optical features of serrated adenomas are extracted from the database. Discriminators are then defined on the basis of the extracted features. In the second phase a test set of high quality pictures are provided to both novices and experts of colorectal endoscopy. Participants are asked to use the above named discriminators in order to rate pictures and to classify polyps into three classes (adenomatous polyps, hyperplastic polyps and serrated adenomas). In the third phase of the study accuracy of optical bases diagnoses is calculated by comparing optically derived diagnoses with histopathological diagnoses (gold standard).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: April 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• indication for colonoscopy

• patients >= 18 years

Exclusion Criteria:

• pregnant women

• indication for colonoscopy: inflammatory bowel disease

• indication for colonoscopy: polyposis syndrome

• indication for colonoscopy: emergency colonoscopy e.g. acute bleeding

• contraindication for polyp resection e.g. patients on warfarin

Related Conditions & MeSH terms

• Adenoma
• Colorectal Neoplasms

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar der TU München	Munich	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optical diagnosis of each colorectal polyp	The predicted polyp histology (determined according to optical polyp features) will be assessed; the predicted diagnosis will be compared with the histopathological diagnosis (gold standard) after;	Participants will be followed for the duration of the study an expected average of 6 month