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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260321
• Other study ID #: 2363-2
• Status: Completed
• Start date: February 19, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2020
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colon Cancer

Intervention

Device:
• AI
Artificial intelligence colonoscopy

Locations

Country	Name	City	State
Italy	Fondazione Poliambulanza	Brescia	Italia
Italy	Ospedale Valduce	Como
Italy	Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital	Rome
Italy	Endoscopy Unit, Humanitas Research Hospital	Rozzano	Milano
Switzerland	Ente Ospedaliero Cantonale, Ospedale Italiano	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Countries where clinical trial is conducted

Italy,  Switzerland, 

Outcome

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