Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963191
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-07-10
Brief Title:
CAD-EYE System for the Detection of Neoplastic Lesions in Patients With Lynch Syndrome
Sponsor:
PERROD Guillaume
Organization:
French Society of Digestive Endoscopy
Study Overview
Official Title:
Evaluation of the CAD-EYE System for the Detection of Colorectal Neoplastic Lesions in Patients With Lynch Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CADLYNCH
Brief Summary:
Lynch syndrome LS is the most common genetic predisposition syndrome for colorectal cancer CRC responsible for around 2-4 of cancers It is characterized by a pathogenic germline mutation in one of the DNA mismatch repair genes path_MMR MLH1 MSH2 MSH6 PMS2 or a deletion in the 3 region of the Epcam gene Patients followed up for LS are at high risk of developing CRC at an early age and have a high cumulative CRC risk In this context CRC screening by colonoscopy is of major importance as it is associated with a reduction in both CRC incidence and mortality
In France the Institut National du Cancer INCa recommends colonoscopy with indigo carmine chromoendoscopy CE as it is associated with a significant increase in the adenoma detection rate ADR compared with white light However EC is not routinely performed in clinical practice as it is a time-consuming technique requiring a dedicated slot with a trained operator
Recent years have seen the emergence of artificial intelligence techniques for real-time polyp detection aids or CADe devices These easy-to-use systems have shown very promising results compared with high-definition HD white light Indeed data from the first meta-analysis of 5 randomized controlled trials 4354 patients confirmed a significantly higher ADD in the CADe group than in the HD group 366 vs 252 95 CI 127-162 P 001 I2 Z 42 10 The CAD EYE system Fujifilm is a CADe device supporting both detection sensitivity 95 and characterization of colonic polyps in real time
To date artificial intelligence has never been evaluated for CRC screening in patients followed up for LS The aim of this work is to evaluate the effectiveness of the CAD EYE system in this specific population To this end we intend to conduct a randomized controlled non-inferiority trial comparing CAD EYE with CE in patients with LS
In France the Institut National du Cancer INCa recommends colonoscopy with indigo carmine chromoendoscopy CE as it is associated with a significant increase in the adenoma detection rate ADR compared with white light However EC is not routinely performed in clinical practice as it is a time-consuming technique requiring a dedicated slot with a trained operator
Recent years have seen the emergence of artificial intelligence techniques for real-time polyp detection aids or CADe devices These easy-to-use systems have shown very promising results compared with high-definition HD white light Indeed data from the first meta-analysis of 5 randomized controlled trials 4354 patients confirmed a significantly higher ADD in the CADe group than in the HD group 366 vs 252 95 CI 127-162 P 001 I2 Z 42 10 The CAD EYE system Fujifilm is a CADe device supporting both detection sensitivity 95 and characterization of colonic polyps in real time
To date artificial intelligence has never been evaluated for CRC screening in patients followed up for LS The aim of this work is to evaluate the effectiveness of the CAD EYE system in this specific population To this end we intend to conduct a randomized controlled non-inferiority trial comparing CAD EYE with CE in patients with LS
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None