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In Vivo Computer-aided Prediction of Polyp Histology on White Light Colonoscopy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775811
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Ana García-Rodríguez, Hospital Clinic of Barcelona

Brief Summary:

In a previous study, our group developed a computer assisted system (CAD) based on the extraction of polyp surface patterns using high-definition white light (WL-HD). This CAD was able to distinguish between dysplastic and non-dysplastic polyps with an accuracy> 90%.

The current goal is to validate an improved version of this system in routine clinical practice. Since both the American Society of Gastrointestinal Endoscopy (ASGE) and the European Society of Gastrointestinal Endoscopy (ESGE) recommend performing optical diagnosis only by expert professionals and for diminutive polyps, the main objective of our study will be to assess the accuracy of the method for polyps of small size in real life during colonoscopies performed by endoscopists with different levels of expertise in optical diagnosis. The performance of the CAD method will be compared with the in-situ histological prediction made by the endoscopists and it will be recorded if their decision changes based on the system prediction. Histological analysis will be the gold standard.


Condition or disease Intervention/treatment
Colonoscopy Histology Computer Artificial Intelligence Colorectal Polyp Adenoma Colon Polyp Hyperplastic Polyp Other: Computer-assisted histological prediction of colon polyps

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Study Type : Observational
Estimated Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: In Vivo Computer-aided Prediction of Polyp Histology on White Light Colonoscopy
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : June 23, 2020
Estimated Study Completion Date : June 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy


Intervention Details:
  • Other: Computer-assisted histological prediction of colon polyps
    The objective is to validate in real clinical practice an improved version of our computer histological prediction system


Primary Outcome Measures :
  1. Accuracy of the computer-aided system for predicting polyps histology in real clinical practice [ Time Frame: One year ]
    The results of the computer-aided system prediction will be compared with the final pathology report, which is the gold standard



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with polyps with a size of 10 mm or less, of any location and morphology, detected in a routine or screening colonoscopy, that are resected endoscopically and recovered for histological analysis will be included. The images obtained will be used to expand the database.
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Approval of participation in the study. Signature of informed consent
  • Patients with at least one polyp of size equal to or less than 10 mm diagnosed in a routine or screening colonoscopy, regardless of location and morphology
  • Endoscopies performed with high definition endoscopes

Exclusion Criteria:

  • Age <18 years
  • Refusal to participate in the study
  • Polyps partially resected in a previous endoscopy
  • Patients with inflammatory disease
  • Impossibility to wash remains of stool or mucus on the surface of the polyp

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): NCT03775811


Contacts
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Contact: Gloria Fernández-Esparrach, MD, PhD +34932275400 ext 5513 mgfernan@clinic.cat

Locations
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Spain
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Gloria Fernández-Esparrach, MD, PhD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Instituto de Salud Carlos III
Publications:
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Responsible Party: Ana García-Rodríguez, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT03775811    
Other Study ID Numbers: HISINVIA
PI17/00894 ( Other Grant/Funding Number: Instituto de Salud Carlos III )
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 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
Polyps
Pathological Conditions, Anatomical
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms