Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions

NCT07066046 | Recruiting

• 1 other identifier: 64060322.7.0000.0068
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the effectiveness of artificial intelligence-assisted colonoscopy in increasing adenoma detection rate and the accuracy in the characterization of colorectal lesions, compared to standard colonoscopy, in a randomized controlled clinical trial setting.

Conditions

Colorectal Cancer (CRC); Adenomatous Polyposis; Colorectal Lesions; Colorectal Cancer

Keywords

Adenoma; Artificial Intelligence; Colonoscopy; Colorectal lesions

Outcome Measures

Primary Outcomes (1)

• Number of patients with at least one adenoma detected, confirmed by histopathological analysis, during colonoscopy, in the AI group vs. control group

  The measure will be expressed as the number and percentage (%) of patients with at least one adenoma detected during colonoscopy and confirmed by histopathological analysis, comparing the AI and non-AI groups (CAD EYE). Detection will be based on the analysis of biopsies performed and processed according to the standard protocol.

  7 days after colonoscopy (estimated time for histopathological report release).

Secondary Outcomes (1)

• Diagnostic accuracy of CAD EYE for characterization of lesions as neoplastic (adenoma) or non-neoplastic (hyperplastic), compared to histopathological analysis as the gold standard.

  7 days after colonoscopy

Study Arms (2)

Colonoscopy with the aid of artificial intelligence

ACTIVE COMPARATOR

Stratum 1: Patients aged 18 to 44 years Stratum 2: Patients aged 45 to 75 years Stratum 3: Patients aged 76 years or older

Procedure: Colonoscopy

Colonoscopy without the aid of artificial intelligence

ACTIVE COMPARATOR

Stratum 1: Patients aged 18 to 44 years Stratum 2: Patients aged 45 to 75 years Stratum 3: Patients aged 76 years or older

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

This single-center, randomized, open-label clinical trial will assess the effectiveness of artificial intelligence (AI)-assisted colonoscopy versus standard high-definition colonoscopy in detecting and characterizing colorectal lesions. Conducted over 12 months in São Paulo, Brazil, the study will include 100 adult patients undergoing elective colonoscopy. Participants will be stratified by age and randomized (1:1) after sedation. All lesions will be resected, recorded, and analyzed histologically. The intervention group will also include AI output data (CAD EYE). The primary goals are to evaluate adenoma detection rate (ADR) and AI diagnostic accuracy. Given the global burden of colorectal cancer (CRC), particularly in developing countries, this study aims to provide real-world data on the impact of AI in CRC screening.

Colonoscopy with the aid of artificial intelligence; Colonoscopy without the aid of artificial intelligence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged 18 years or older, with an elective indication for colonoscopy who sign the informed consent form agreeing to participate in the study.

You may not qualify if:

• History of inflammatory bowel disease.
• History of colorectal cancer.
• Personal history of colorectal surgery.
• Contraindication to endoscopic biopsies.
• History of intestinal polyposis syndromes.
• Urgent or emergency cases.
• Presence of severe, decompensated comorbidities, or with a score of 3 or higher according to the American Society of Anesthesiologists (ASA) classification.
• Incomplete colonoscopy that does not reach the cecum.
• Insufficient or inadequate bowel preparation, with a score lower than 6 on the Boston Bowel Preparation Scale.
• Patients who do not agree to participate in the study and do not sign the informed consent form (ICF).

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

Related Links

• Shaukat A, Kahi CJ, Burke CA, Rabeneck L, Sauer BG, Rex DK. ACG Clinical Guidelines: Colorectal Cancer Screening 2021. Am J Gastroenterol \[Internet\]. 2021 Mar;116(3):458-79.
• Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, et al. Adenoma Detection Rate and Risk of Colorectal Cancer and Death. N Engl J Med \[Internet\]. 2014 Apr 3;370(14):1298-306
• Repici A, Badalamenti M, Maselli R, Correale L, Radaelli F, Rondonotti E, et al. Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial. Gastroenterology \[Internet\]. 2020 Aug;159(2):512-520.e7.
• Wang P, Liu X, Berzin TM, Glissen Brown JR, Liu P, Zhou C, et al. Effect of a deeplearning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study. Lancet Gastroenterol Hepatol \[Internet\].
• Gong D, Wu L, Zhang J, Mu G, Shen L, Liu J, et al. Detection of colorectal adenomas with a real-time computer-aided system (ENDOANGEL): a randomised controlled study. Lancet Gastroenterol Hepatol \[Internet\]. 2020 Apr;5(4):352-61.
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• Kudo S, Hirota S, Nakajima T, Hosobe S, Kusaka H, Kobayashi T, et al. Colorectal tumours and pit pattern. J Clin Pathol \[Internet\]. 1994 Oct 1;47(10):880-5.
• Kimura T, Yamamoto E, Yamano H, Suzuki H, Kamimae S, Nojima M, et al. A Novel Pit Pattern Identifies the Precursor of Colorectal Cancer Derived From Sessile Serrated Adenoma. Am J Gastroenterol \[Internet\]. 2012 Mar;107(3):460- 9
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MeSH Terms

Conditions

Colorectal Neoplasms; Adenomatous Polyposis Coli; Adenoma

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenomatous Polyps; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Syndromes, Hereditary; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Márcio Roberto Facanali Júnior

CONTACT

+55 19 99825-2870; marcio.facanali@hc.fm.usp.br

Adriana Vaz Safatle Ribeiro, PhD

CONTACT

+55 19 99825-2870

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistente - Endoscopia ICESP

Model Details: A controlled, open-label, prospective, randomized clinical study is proposed, to be conducted at a single center in a Brazilian referral hospital for colorectal cancer located in São Paulo, São Paulo. Over a period of 12 consecutive months, patients who agree to participate in the study will undergo a colonoscopy. All patients aged 18 years or older, with an elective indication for colonoscopy, who sign the informed consent form agreeing to participate in the study, will be included.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: July 15, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)