European Serrated Adenoma Classification Score

NCT ID: NCT03486418

Last Updated: 2020-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinikum rechts der Isar der TU München

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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ESCO

Identifier Type: -

Identifier Source: org_study_id

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