Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05928819
Status:
RECRUITING
Last Update Posted:
2023-07-03
First Post:
2023-06-23
Brief Title:
Evaluation of a Computer-aided Diagnosis System CADx in the Early Detection of Gastric Cancer in France Cancer in France
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Early Detection of Gastric Cancer in France Evaluation of the Diagnostic Capacity of a Computer-aided Diagnostic System CADx Compared to Endoscopists EGC-France
Status:
RECRUITING
Status Verified Date:
2023-06
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:
EGC-France
Brief Summary:
Upper gastrointestinal GI cancers are one of the most common cancers worldwide Except for cardia cancers the incidence of gastric cancer has decreased consistently since 1980 but remains at a high level In France gastric cancers are the 6th most common cause of cancer-related mortality The risk factors of upper GI cancers are well known and their control could prevent the development of cancers smoking cessation reduction of obesity alcohol eradication of Helicobacter pylori But late presentation with upper GI cancer results in a poorer prognosis Patients with advanced Stage IV gastric cancer have a five-year survival rate of 37 whereas patients whose gastric cancer is discovered in its early stage Stage I have a significantly higher five-year survival rate of 884 Therefore endoscopic detection of upper GI lesions at an earlier stage is the single most effective measure for reducing cancer mortality But upper GI cancer is also often missed during examinations and some studies demonstrated a missed cancer rate of 23-139 in Western populations In the past decade accurate diagnosis during endoscopy has become particularly important as dysplastic lesions and early gastric cancers can be treated effectively with both endoscopic mucosal resection EMR and endoscopic submucosal dissection ESD avoiding the morbidity and mortality associated with gastrectomy However these early neoplastic lesions can be sometimes difficult to distinguish from background mucosa even with advanced imaging techniques high definition chromoendoscopy
In recent years image recognition using artificial intelligence AI with deep learning has dramatically improved and opened the door to more detailed image analysis and real time application in various medical field including endoscopy For example in the colorectal cancer screening area real time computer-aided detection systems CADe can lead to significant increases in both polyp and adenoma detection rates
CADe has also shown good performance in detection of Barretts neoplasia during live endoscopic procedures in order to more accurately locate the area to be biopsied Recently a Chinese study showed that CADe achieved high diagnostic accuracy in detecting upper GI cancers with sensitivity similar to that of expert endoscopists and superior to that of non-experts This system could support non-experts by improving their diagnostic accuracy to a level similar to that of experts and provide assistance for improving the effectiveness of upper GI cancer diagnosis and screening
Although encouraging results have been published regarding the use of AI in the diagnosis of upper GI cancers the clinical applicability of such systems in a European population has yet to be investigated
Therefore we want to evaluate the diagnostic capability of a recent CADx compared to endoscopists in order to improve the real-time detection of early gastric cancers in our European center Edouard Herriot Hospital Lyon France as well as 3 other tertiary centers in France Limoges Rennes and Nancy University Hospitals
With a high prevalence of stomach cancer Japan is a world leader in high-quality diagnostic upper GI endoscopy and the clinical routine in this country differs substantially from Western practice with population-based screening programs We will use for our study a CADx developed by AI medical service Inc 1-18-1 Higashiikebukuro Toshima-ku Tokyo 170-0013 Japan a Japanese company developing AI systems that supports endoscopists diagnosis for the digestive tract A recent study involving AI medical service system showed good results in the diagnosis of early gastric cancer compared to endoscopists with a significantly higher sensitivity
In recent years image recognition using artificial intelligence AI with deep learning has dramatically improved and opened the door to more detailed image analysis and real time application in various medical field including endoscopy For example in the colorectal cancer screening area real time computer-aided detection systems CADe can lead to significant increases in both polyp and adenoma detection rates
CADe has also shown good performance in detection of Barretts neoplasia during live endoscopic procedures in order to more accurately locate the area to be biopsied Recently a Chinese study showed that CADe achieved high diagnostic accuracy in detecting upper GI cancers with sensitivity similar to that of expert endoscopists and superior to that of non-experts This system could support non-experts by improving their diagnostic accuracy to a level similar to that of experts and provide assistance for improving the effectiveness of upper GI cancer diagnosis and screening
Although encouraging results have been published regarding the use of AI in the diagnosis of upper GI cancers the clinical applicability of such systems in a European population has yet to be investigated
Therefore we want to evaluate the diagnostic capability of a recent CADx compared to endoscopists in order to improve the real-time detection of early gastric cancers in our European center Edouard Herriot Hospital Lyon France as well as 3 other tertiary centers in France Limoges Rennes and Nancy University Hospitals
With a high prevalence of stomach cancer Japan is a world leader in high-quality diagnostic upper GI endoscopy and the clinical routine in this country differs substantially from Western practice with population-based screening programs We will use for our study a CADx developed by AI medical service Inc 1-18-1 Higashiikebukuro Toshima-ku Tokyo 170-0013 Japan a Japanese company developing AI systems that supports endoscopists diagnosis for the digestive tract A recent study involving AI medical service system showed good results in the diagnosis of early gastric cancer compared to endoscopists with a significantly higher sensitivity
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 69HCL21_1313 | OTHER | HCL | None |