Development and Validation of a Deep Learning Algorithm to Evaluate Endoscopic Disease Activity of Ulcerative Colitis.

June 1, 2019 updated by: Xiuli Zuo, Shandong University

Real-time Evaluation of Severity and Mucosal Healing in Patients With Ulcerative Colitis by a Deep Learning Algorithm: a Multi-center Prospective Study.

The purpose of this study is to develop an artificial intelligence(AI) assisted scoring system, which can evaluate the disease severity and mucosal healing stage in patients with ulcerative colitis. Then testify whether this new scoring system can help physicians to enhance the accuracy of disease severity assessments in a multi-center clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ulcerative colitis is a non-specific chronic inflammation of gut characterized by referral bloody stool, diarrhea and abdominal pain. Endoscopic features of the disease severity and mucosal healing stage are strongly associated with treatment response and prognosis in the future. Currently, the Mayo endoscopic sub-score (Mayo ES) and Ulcerative colitis endoscopic index of severity (UCEIS) are commonly recommended to guide therapeutic adjustments. However, the accuracy of these scales greatly relies on intra-observer and inter-observer consistency for lack of objective measurements. Recently, deep learning algorithm based on convolutional neural network (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. Up to now, no randomized controlled trials have been conducted to evaluate the performance of deep learning algorithm for assessing disease activity in ulcerative colitis. This study aims to train a deep learnig algorithm to assess severity and mucosal healing stage of ulcerative colitis using the Mayo ES and UCEIS scale, then testify whether the engagement of AI can improve the evaluation accuracy of physicians in a multi-center clinical practice.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 257000
        • Qilu hosipital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with ulcerative colitis undergoing colonoscopy

Exclusion Criteria:

  • Known or suspected bowel obstruction, stricture or perforation
  • Compromised swallowing reflex or mental status
  • Severe congestive heart failure (New York Heart Association class III or IV)
  • Uncontrolled hypertension (systolic blood pressure > 170 mm Hg, diastolic blood pressure > 100 mm Hg)
  • Pregnancy or lactation
  • Hemodynamically unstable
  • Colonic surgery history
  • Bad bowel preparation (segmental BBPS<2)
  • Unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Artificial Intelligence assisted Scoring Group
Patients in this group go through colonoscopy under the AI monitoring device.
Device: Artificial inteligence associated ulcerative colitis severity scoring system
Patients in this group go through a flexible colonoscopy under the AI monitoring device. During the withdrawal process, inflammatory lesions are detected by AI-associated scoring system. Pictures are automatically captured and analyzed by the computer. The Mayo ES and UCEIS sores will be calculated and presented on a second screen, providing a reference for the physician to evaluate the disease severity and mucosal healing stage of the patient. Biopsies will be taken from inflammatory region for histological examination. Videos will be recorded and re-evaluated by a group of experts to determine the final Mayo ES and UCEIS scores.
Active Comparator: Conventional Human Scoring Group
Patients in this group go through conventional colonoscopy without AI monitoring device.
Device: Conventional human scoring
Patients in this group go through a conventional colonoscopy without the AI monitoring device. During the withdrawal process, physician evaluates the disease severity and mucosal healing stage of the patient according to his personal experience. Biopsies will be taken from inflammatory region for histological examination. Videos will be recorded and re-evaluated by a group of experts to determine the final Mayo ES and UCEIS scores.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The scoring accuracy of Mayo ES in AI-associated group and conventional group.
Time Frame: 6 months
The scoring accuracy of Mayo endoscopic sub-score (Mayo ES) in each group will be calculated using scores from expert group as reference standard. The Mayo ES is a 4-point scale, which classifies the endoscopic severity of ulcerative colitis into the following four categories: point 0 refers to normal or inactive disease, point 1 refers to mild disease with erythema, decreased vascular patterns and mild friability, point 2 refers to moderate disease with marked erythema, absence of vascular patterns, friability and erosions, point 3 refers to severe disease with spontaneous bleed and ulceration. The scoring accuracy of Mayo ES ranging from 0 to 3 point will be separately evaluated in both groups.
6 months
The scoring accuracy of UCEIS in AI-associated group and conventional group.
Time Frame: 6 months
The scoring accuracy of Ulcerative colitis endoscopic index of severity (UCEIS) in each group will be separately calculated using scores from expert group as reference standard. The UCEIS is an 8-point scale consists of 3 parts: vascular pattern (point 0 refers to normal mucosa, point 1 refers to patchy obliteration of vascular pattern, point 2 refers to complete obliteration of vascular pattern), bleeding (point 0 refers to no visible blood, point 1 refers to some spots of coagulated blood, point 2 refers to free liquid, point 3 refers to frank blood in the lumen), erosions and ulcers (point 0 refers to normal mucosa, point 1 refers to erosions, point 2 refers to superficial ulcers, point 3 refers to deep ulcers. The total UCEIS score summarized by the above 3 parts will be analyzed. The scoring accuracy of UCEIS ranging from 0 to 8 point will be separately evaluated in both group.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The accuracy of mucosal healing judgements using Mayo ES in each group.
Time Frame: 6 months
The accuracy of mucosal healing judgements using Mayo ES will be calculated in each group. Assessments from expert group will be used as reference standard. Complete mucosal healing is defined as point 0 in Mayo ES scale, which refers to normal or inactive disease.
6 months
The accuracy of mucosal healing judgements using UCEIS in each group.
Time Frame: 6 months
The accuracy of mucosal healing judgements using UCEIS will also be calculated in each group. Assessments from expert group will be used as reference standard. Complete mucosal healing is defined as point 0 in UCEIS scale, which refers to normal vascular pattern without bleeding, erosions and ulceration.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-SDU-QILU-G002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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