The AID Study 2: Artificial Intelligence for Colorectal Adenoma Detection 2

Colonoscopy is clinically used as the gold standard for detection of colon cancer (CRC) and removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related deaths, there exists a disappointing level of adenomas missed at colonoscopy. "Back-to-back" colonoscopies have indicated significant miss rates of 27% for small adenomas (< 5 mm) and 6% for adenomas of more than 10 mm in diameter. Studies performing both CT colonography and colonoscopy estimate that the colonoscopy miss rate for polyps over 10 mm in size may be as high as 12%. The clinical importance of missed lesions should be emphasized because these lesions may ultimately progress to CRC.

Limitations in human visual perception and other human biases such as fatigue, distraction, level of alertness during examination increases such recognition errors and way of mitigating them may be the key to improve polyp detection and further reduction in mortality from CRC. In the past years, a number of CAD systems for detection of polyps from endoscopy images have been described. However, the benefits of traditional CAD technologies in colonoscopy appear to be contradictory, therefore they should be improved to be ultimately considered useful. Recent advances in artificial intelligence (AI), deep learning (DL), and computer vision have shown potential to assist polyp detection during colonoscopy.

Average experienced endoscopists (each having performed <2000 screening colonoscopies) will perform the endoscopic procedure.

Study Overview

• Status: Completed
• Conditions: Colon Cancer
• Intervention / Treatment: Device: AI

• Study Type: Observational
• Enrollment (Actual): 700

Contacts and Locations

Study Locations

• Italy
  • Como, Italy, 22100
    • Ospedale Valduce
  • Rome, Italy, 00153
    • Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital
  • Italia
    • Brescia, Italia, Italy
      • Fondazione Poliambulanza
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Endoscopy Unit, Humanitas Research Hospital
• Switzerland
  • Lugano, Switzerland, 6900
    • Ente Ospedaliero Cantonale, Ospedale Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Based on the observed prevalence of adenomas (35%) among patients undergoing colonoscopies at our center within the last 12 months, a sample size of 322 subjects per arm could allow for a 90% power to show the non-inferiority (primary end-point) of the AI-aided arm by excluding that the one-side 95% CI will exclude a difference of 10% in favour of the standard group. Such sample size will also have a 80% power to detect as statistical significant (α=0.05; two-sided test) a 10% absolute increase in the detection rate of adenomas in the AI-aided arm (secondary end-point).

Performing a sub-stratification according to operator experience, we will planning to enroll the 322 subjects per arm performed by experts and 322 subjects per arm performed by average operator.

Description

Inclusion Criteria:

• All 40-80 years-old subjects undergoing a colonoscopy

Exclusion Criteria:

• subjects with personal history of CRC, or IBD.
• patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale > 2 in any colonic segment).
• patients with previous colonic resection.
• patients on antithrombotic therapy, precluding polyp resection.
• patients who were not able or refused to give informed written consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AI; Artificial intelligence colonoscopy	Device: AI; Artificial intelligence colonoscopy
Control; White light colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferiority of AI-aided colonoscopy in terms of ADR	The proportion of participants with at least one adenoma (per-patient analysis).	5 Months

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Alessandro Repici, MD, Humanitas Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Artificial Intelligence
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 2363-2

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