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

Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions: Randomized Controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07066046
Enrollment
1000
Registered
2025-07-15
Start date
2025-02-01
Completion date
2026-12-01
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Adenoma, Artificial Intelligence, Colonoscopy, Colorectal lesions

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.

Detailed description

Colorectal cancer (CRC) currently shows, according to GLOBOCAN, an incidence of 19.5 individuals per 100,000 inhabitants in both sexes, being the third most common cancer in men and the second in women, representing the third leading cause of death in both men and women. According to the GLOBOCAN registry of the World Health Organization (WHO), it is estimated that CRC is the third most common type of cancer worldwide, responsible for 10% of all newly diagnosed cancer cases, corresponding to 1,931,590 cases in 2020, preceded only by lung cancer (11.4%) and breast cancer (11.7%). CRC is the second leading cause of cancer mortality (9.4%; 935,173 cases in 2020), following only lung cancer, which accounts for 18% of cancer deaths globally. In Brazil, according to data from the National Cancer Institute (INCA), CRC mirrors the global incidence, being the second most common cancer by sex. Colonoscopy is the most accurate CRC screening method, with sensitivity reaching 100% in the detection of colorectal lesions. According to studies, for each 1% increase in adenoma detection rate, there is a 5% decrease in CRC mortality, highlighting the importance of performing colonoscopy to detect colorectal lesions, especially adenomas. Consequently, with the advancement of technology, new high-definition endoscopes with virtual chromoscopy and image magnification have been developed to increase adenoma detection rates. More recently, AI-assisted colonoscopy has been gaining prominence in helping prevent CRC in some medical centers worldwide, such as in Japan. In a multicenter study with 700 patients in 2019, a significantly higher adenoma detection rate was demonstrated with AI-assisted colonoscopy compared to standard colonoscopy (54.8% vs. 40.4%). Subsequently, a randomized, double-blind clinical trial with 1,058 patients was conducted, comparing standard colonoscopy to AI-assisted colonoscopy. The result was an adenoma detection rate of 29% for AI-assisted colonoscopy and 20% for standard colonoscopy, with the difference being statistically significant. Two other studies comparing AI-assisted colonoscopy and standard colonoscopy showed similar results. However, when analyzing the accuracy of AI systems in characterizing colorectal lesions, different results are observed in the literature. On one hand, Japanese studies report accuracies above 90% in characterizing neoplastic and non-neoplastic lesions with artificial intelligence, while other studies, such as the Dutch study and the German study, found accuracies of 74.4% and 84.7%, respectively, results significantly lower compared to the Japanese studies. Therefore, given not only the differences in results obtained by various authors but also the differences in population and the lack of studies on AI-assisted colonoscopy in developing countries, the objective of this work is to evaluate the adenoma detection rate of AI-assisted colonoscopy and assess the accuracy of artificial intelligence in characterizing colorectal lesions.

Interventions

PROCEDUREColonoscopy

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.

Sponsors

Instituto do Cancer do Estado de São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with at least one adenoma detected, confirmed by histopathological analysis, during colonoscopy, in the AI group vs. control group7 days after colonoscopy (estimated time for histopathological report release).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.

Secondary

MeasureTime frameDescription
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 colonoscopyThe accuracy of artificial intelligence (CAD EYE) in characterizing detected lesions as neoplastic or non-neoplastic will be calculated, based on comparison with histopathological diagnosis (gold standard). The following will be reported: sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), in percentage (%), for each type of lesion.

Countries

Brazil

Contacts

CONTACTMárcio Roberto Facanali Júnior
marcio.facanali@hc.fm.usp.br+55 19 99825-2870
CONTACTAdriana Vaz Safatle Ribeiro, PhD
+55 19 99825-2870

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026