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NCT05942677: AIChallengeMed
Comparison of Flat Colorectal Lesion Detection by Artificial Intelligence-assisted Colonoscopy Versus Endoscopists
trial testing proportion of colorectal lesions in Flat Colorectal Lesion in 160 participants. Status unknown.
1 June 2022
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 160 |
| Start date | 1 January 2022 |
| Primary completion | 1 June 2022 |
| Estimated completion | 30 December 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- proportion of colorectal lesions
Conditions studied
- Flat Colorectal Lesion — all drugs for Flat Colorectal Lesion →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
18 and older, any sex, with Flat Colorectal Lesion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The development of artificial intelligence (AI) systems in the field of colorectal endoscopy is currently booming, colorectal cancer being, by its frequency and severity, a real public health problem. In terms of image analysis, AI is indeed able to perform many tasks simultaneously (lesion detection, classification, and segmentation) and to combine them. Lesion detection is thus the starting point of the whole chain to choose at the end the most appropriate treatment for the patient. Large-scale studies have demonstrated the superiority of artificial intelligence-assisted detection over the usual detection by gastroenterologists, mainly for the detection of sub-centimeter polyps. However, the investigators have shown that a recent computer-aided detection system (CADe) such as the ENDO-AID software in combination with the EVIS X1 video column (Olympus, Tokyo, Japan) may present difficulties in the detection of flat lesions such as sessile serrated lesions (SSLs) and non-granular laterally spreading tumors (LST-NGs). This represents a major challenge because in addition to their shape being difficult to identify for the human eye in practice and where AI assistance would be of great value, these rare lesions are associated with advanced histology. In addition, the investigators recently described the case of a worrisome false negative of AI-assisted colonoscopy, which failed to detect a flat adenocarcinoma in the transverse colon. Therefore, it is important to measure the false negative rate of AI detection based on the macroscopic shape of the lesion. Comparing this rate to the human endoscopist's false negatives would improve the performance of AI for this specific lesion subtype in the future.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05942677 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
- Last refreshed: 13 November 2023
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