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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1060220108
Enrollment
204
Registered
2023-03-07
Start date
2023-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early gastric cancer

Interventions

None listed

Sponsors

Kawahara Yoshiro
Lead Sponsor
Ryobi Systems co., ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 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.

Exclusion criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
Sensitivity of mucosal gastric cancer (M cancer) diagnosed by this program.

Secondary

MeasureTime frame
1) 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.

Contacts

Public ContactShoichiro Hirata

Okayama University Hospital

p6q09uf6@okayama-u.ac.jp+81-86-235-7219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026