Prospective study on the development of computer-aided diagnostic systems focused on the JNET classifications for colorectal lesions

Prospective study on the development of computer-aided diagnostic systems focused on the JNET classifications for colorectal lesions - Prospective study on development of computer-aided diagnostic systems focused on the JNET classifications

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056392

Enrollment

1500

Registered

2025-01-01

Start date

2025-01-01

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

colorectal neoplasia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with one or more colorectal neoplastic lesions (SSL, TSA, adenoma, cTis, or cT1a lesions) scheduled for endoscopic treatment. (2) Patients with one or more lesions classified as cT1b or deeper scheduled for surgical treatment. (3) Patients aged 18 years or older.

Exclusion criteria

Exclusion criteria: (1) Patients with polyposis symdrome (e.g., familial adenomatous polyposis, Lynch syndrome, or SPS [Serrated Polyposis Syndrome]). (2) Patients with inflammatory bowel disease. (3) Patients with coexisting advanced colorectal cancer. (4) Patients with inadequate bowel preparation, indicated by a BBPS (Boston Bowel Preparation Scale) score of less than 6. (5) Cases where the principal investigator or sub-investigators deem participation in the study to be inappropriate.

Design outcomes

Primary

Measure	Time frame
Study 1: Diagnostic concordance rate between CADx and expert endoscopists Study 2: Diagnostic concordance rate with expert endoscopists for both CADx and non-expert endoscopists	—

Secondary

Measure	Time frame
Study 1: increase in confidence level among expert endoscopists diagnostic accuracy for identifying jnet 1/2a lesions as resect-and-discard lesions (for lesions <10 mm) concordance rate with surveillance intervals recommended by japanese guidelines correlation with histopathological findings withdrawal time study 2: diagnostic concordance rate with expert endoscopists when the real-time ai-assisted colonoscopy device (cadx) and non-expert endoscopists' diagnoses are consistent increase in confidence level among non-expert endoscopists and diagnostic concordance rate with expert endoscopists for high-confidence lesions learning curve of non-expert endoscopists diagnostic accuracy for identifying jnet 1/2a lesions as resect-and-discard lesions (for lesions <10 mm) concordance rate with surveillance intervals recommended by japanese guidelines correlation with histopathological findings withdrawal time	—

Measure

Time frame

Study 1: increase in confidence level among expert endoscopists diagnostic accuracy for identifying jnet 1/2a lesions as resect-and-discard lesions (for lesions <10 mm) concordance rate with surveillance intervals recommended by japanese guidelines correlation with histopathological findings withdrawal time study 2: diagnostic concordance rate with expert endoscopists when the real-time ai-assisted colonoscopy device (cadx) and non-expert endoscopists' diagnoses are consistent increase in confidence level among non-expert endoscopists and diagnostic concordance rate with expert endoscopists for high-confidence lesions learning curve of non-expert endoscopists diagnostic accuracy for identifying jnet 1/2a lesions as resect-and-discard lesions (for lesions <10 mm) concordance rate with surveillance intervals recommended by japanese guidelines correlation with histopathological findings withdrawal time

—

Countries

Japan

Contacts

Public ContactToshio Kuwai

Hiroshima University Hospital, Hiroshima, Japan Gastrointestinal Endoscopy and Medicine

kuwai@hiroshima-u.ac.jp082-257-5193

Outcome results