European Serrated Adenoma Classification Score
ESCO
Development of an Endoscopic Classification Score System for Serrated Adenomas in the Colorectum
1 other identifier
observational
250
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2018
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedSeptember 18, 2020
September 1, 2020
2.4 years
March 27, 2018
September 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Patients undergoing routine colonoscopy
You may qualify if:
- indication for colonoscopy
- patients \>= 18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum rechts der Isar der TU München
Munich, Bavaria, 81675, Germany
Biospecimen
Colorectal polyps
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2018
First Posted
April 3, 2018
Study Start
April 1, 2018
Primary Completion
September 1, 2020
Study Completion
April 1, 2021
Last Updated
September 18, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share