Tokyo, Dec. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059254) titled 'An exploratory observational study to examine the additional benefit of the CADe program aimed at supporting early gastric cancer detection by endoscopy' on Dec. 31.
Study Type:
Observational
Primary Sponsor:
Institute - Fukuoka University
Condition:
Condition - Gastric cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To exploratory study the additional benefit of CADe, which was developed to support the endoscopic detection of early gastric cancer, on the diagnostic ability of endoscopists using existing data (endoscopic video).
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Inclusion criteria for acquired endoscopic video information
Patients aged 20 years or older
Patients who have personally agreed to participate in the previous study
Patients who have not undergone total gastrectomy
Patients who have been found to have early gastric cancer through prior testing
Patients who have not been enrolled in other studies in the previous study
Patients who have been deemed by the previous study to be able to comply with instructions regarding the previous study and testing
Patients who have been deemed appropriate for participation in the previous study by the principal investigator (co-investigator)
Inclusion criteria for readers
- Physicians who perform upper gastrointestinal endoscopy as part of their daily work.
- Of the above criteria, an expert endoscopist is defined as someone who holds specialist certification from the Japan Gastroenterological Endoscopy Society and has more than 10 years of experience in gastrointestinal endoscopy, while a non-expert endoscopist is defined as someone who does not hold specialist certification from the Japan Gastroenterological Endoscopy Society and has less than 10 years of experience in gastrointestinal endoscopy.
Key exclusion criteria - Exclusion criteria for acquired endoscopic video information
Cases in which systematic and comprehensive lesion exploration of the entire gastric mucosa was not performed
Exclusion criteria for readers
A doctor who the principal investigator considers unsuitable to conduct this study
Target Size - 14
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 20 Day
Anticipated trial start date - 2025 Year 12 Month 01 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067775
Disclaimer: Curated by HT Syndication.