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European Serrated Adenoma Classification Score (ESCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03486418
Recruitment Status : Active, not recruiting
First Posted : April 3, 2018
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Study Description
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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).


Condition or disease
Colorectal Neoplasms

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Development of an Endoscopic Classification Score System for Serrated Adenomas in the Colorectum
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : September 1, 2020
Estimated Study Completion Date : April 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Optical diagnosis of each colorectal polyp [ Time Frame: Participants will be followed for the duration of the study an expected average of 6 month ]
    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;


Biospecimen Retention:   Samples Without DNA
Colorectal polyps

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing routine colonoscopy
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486418


Locations
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Germany
Klinikum rechts der Isar der TU München
Munich, Bayern, Germany, 81675
Sponsors and Collaborators
Technische Universität München
More Information
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT03486418    
Other Study ID Numbers: ESCO
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases