Impact of Computer-aided Optical Diagnosis (CAD) in Predicting Histology of Diminutive Rectosigmoid Polyps: a Multicenter Prospective Trial (ABC Study). (ABC)

June 9, 2021 updated by: Franco Radaelli, Valduce Hospital

Impact of Computer-aided Optical Diagnosis (CAD) in Predicting Histology of Diminutive Rectosigmoid Polyps: a Multicenter Prospective Trial (Artificial Intelligence BLI Characterization - ABC Study).

Recently, a CNN-based artificial intelligence (AI) system for polyp characterization has been developed by Fujifilm Co., Tokyo, Japan. It works in conjunction with BLI system. In the present study we prospectively evaluate whether the evaluation of the endoscopist combined with the CAD system output achieve > 90% accuracy in characterization (i.e. as adenomas or non-adenomas) of diminutive rectosigmoid polyps having histopathology as reference standard. Consecutive adult outpatients undergoing elective colonoscopy, in which at least one diminutive (<5 mm) rectosigmoid polyp is detected are included. During endoscopic procedures all polyps identified by the endoscopist are documented for size, location and morphology. All diminutive polyps are characterized by a three sequential steps process: I) endoscopist prediction: the endoscopist evaluates the polyp by using BLI through the BASIC classification; the confidence level (high vs. low) in histology prediction is recorded; II) AI prediction: the AI system is switched on and the output of the automatic evaluation is recorded; this outcome is rated as stable or unstable, depending of the consistency over time of the outcome; III) combined prediction: a final classification is provided by endoscopist in light of the results of the first and of the second step; the confidence level is recorded. All polyps are resected and retrieved in separate jars and sent for pathology assessment. Only polyps characterized with high confidence will be included in the per-polyp analysis; the high-confidence characterization rate will be also calculated; the rate of polyps characterized with a CAD stable outcome will be calculated. Operative characteristics (sensitivity, specificity, positive and negative predictive value and accuracy) in distinguishing adenomatous from non-adenomatous polyps, evaluated with high confidence, will be calculated for each diminutive polyp and for each diminutive rectosigmoid polyp, having histopathology report as reference standard. The post-polypectomy surveillance intervals will be calculated on the basis of polyp histology (reference standard) in all patients according to both USMSTF and ESGE guidelines.

Study Overview

Status

Status

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

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.

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.
Observational

Enrollment (Actual)

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.
1134

Contacts and Locations

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

Study Locations

  • Italy
      • Como, Italy, 22100
        • Gastroenterology Unit, Valduce Hospital

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive adult outpatients undergoing elective colonoscopy, in which at least one diminutive (<5 mm) rectosigmoid polyp is detected

Description

Inclusion Criteria:

  • Consecutive adult outpatients undergoing elective colonoscopy, in which at least one diminutive (<5 mm) rectosigmoid polyp is detected.

Exclusion Criteria:

  • patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
  • patients with inadequate bowel preparation
  • patients scheduled for partial examinations
  • polyps could not be resected due to ongoing anticoagulation preventing resection and pathologic assessment
  • patients undergoing urgent colonoscopy

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Patients with at least one diminutive rectosigmoid polyp

Consecutive adult (>18 years) outpatients undergoing elective colonoscopy, in which at least one diminutive (<5 mm) rectosigmoid polyp is detected.

Exclusion criteria:

  • patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
  • patients with inadequate bowel preparation
  • patients in which caecal intubation was not achieved or scheduled for partial examinations
  • polyps could not be resected due to ongoing anticoagulation preventing resection and pathologic assessment
  • patients undergoing urgent colonoscopy.
Diagnostic test: Polyp carachterization by combing endoscopist evaluation and Ai output
A polyp characterization (adenoma vs. non adenoma) is provided by endoscopist in light of the results of this own evaluation and of the Ai system output. The confidence level (high vs. low) in polyp characterization is recorded. The combined evaluation is compared with histopathology results.

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
Agreement of combined prediction with PIVI I statement
Time Frame: 6 months
To prospectively evaluate whether the evaluation of the endoscopist combined with the CAD system output achieve > 90% accuracy in characterization (i.e. as adenomas or non-adenomas) of diminutive rectosigmoid polyps (i.e. PIVI I threshold) having histopathology as reference standard.
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
Endoscopist prediction
Time Frame: 6 months
to calculate the performance measures (sensitivity, specificity, positive and negative predictive value) of the endoscopist alone in characterizing diminutive rectosigmoid polyps
6 months
Ai prediction
Time Frame: 6 months
- to calculate the performance measures (sensitivity, specificity, positive and negative predictive value) of the AI system alone in characterizing diminutive rectosigmoid polyps
6 months
Agreement of combined prediction with PIVI II statement
Time Frame: 6 months
- to evaluate if the evaluation of the endoscopist combined with the CAD system output achieve > 90% accuracy in the assignment of post-polypectomy surveillance intervals, according to US and EU guidelines, when combined with the histopathology assessment of polyps >5 mm in size
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.
Valduce Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
October 22, 2020

Primary Completion (Actual)

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.
February 27, 2021

Study Completion (Actual)

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.
March 30, 2021

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).
October 22, 2020

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.
October 22, 2020

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.
October 28, 2020

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 10, 2021

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 9, 2021

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, 2021

More Information

Terms related to this study

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.
  • 599/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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