NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1060220108

Registered date:07/03/2023

Performance test of a diagnostic support program for evaluating the depth of invasion of early gastric cancer

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedearly gastric cancer
Date of first enrollment01/01/2023
Target sample size204
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeSensitivity of mucosal gastric cancer (M cancer) diagnosed by this program.
Secondary Outcome1) Specificity of mucosal gastric cancer (M cancer) diagnosed by this program. 2) Diagnostic accuracy rate of mucosal gastric cancer (M cancer) diagnosed by this program.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. Individuals who are 20 years of age or older at the time of endoscopic image acquisition. 2. Individuals who can provide early gastric cancer tissue suitable for pathological diagnosis by a pathological evaluator. 3. Individuals who can provide images that meet the following criteria for endoscopic images: Images captured using White Light mode Vertical resolution of 700 pixels or more and horizontal resolution of 800 pixels or more (image area) Images captured using an Olympus or Fujifilm endoscope Five or more images per lesion Suitable for deep depth diagnosis, as shown below The entire gastric tumor is generally visible (without using close-up or magnifying endoscopy, etc.) The details of the tumor's shape can be observed (without moving the lens too far from the tumor) Sufficient insufflation is performed.
Exclude criteria1. The following images are excluded Images that do not show the gastric tumor (such as normal areas) Images taken after treatment such as biopsy or clipping, or images with severe bleeding Images that show foreign objects such as food residue Blurred or unclear images due to poor focus or other factors Images that only show a portion of the lesion due to magnifying endoscopy or close-up photography 2. Individuals who have undergone gastric resection or gastric tube reconstruction at the time of endoscopic image acquisition or specimen collection. 3. Individuals with lesions extending to the esophagus or duodenum at the time of endoscopic image acquisition or specimen collection. 4. Individuals with a history of chemotherapy or radiation therapy to the upper abdomen within the year prior to the target endoscopic examination. 5. Patients who have refused to participate in the study.

Related Information

Contact

Public contact
Name Shoichiro Hirata
Address 2-5-1, Shikata-cho, Kita-ku, Okayama Okayama Japan 700-8558
Telephone +81-86-235-7219
E-mail p6q09uf6@okayama-u.ac.jp
Affiliation Okayama University Hospital
Scientific contact
Name Yoshiro Kawahara
Address 2-5-1, Shikata-cho, Kita-ku, Okayama Okayama Japan 700-8558
Telephone +81-86-235-7219
E-mail yoshirok@md.okayama-u.ac.jp
Affiliation Okayama University Hospital