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Artificial Intelligence-Based Prediction of Invasion Depth in Superficial Esophageal Cancer

A Multi-center Prospective Validation Study of an Endoscopy-Specific Foundation Model (GutCore (SMC FM)) for Predicting Invasion Depth in Superficial Esophageal Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0012269
Enrollment
110
Registered
2026-07-14
Start date
2026-07-20
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

None listed

Interventions

None listed

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria (Applicable to All Three Participating Centers) 1. Patients who undergo upper gastrointestinal endoscopy for clinical care at participating institutions during the study period and for whom endoscopic image data are naturally generated during the examination 2. Adult patients (aged 19 years or older) who undergo endoscopic submucosal dissection (ESD) for superficial esophageal cancer or suspected superficial esophageal neoplasia 3. Availability of diagnostic endoscopic images obtained before ESD and pre-procedural endoscopic images acquired on the day of ESD 4. Endoscopic image data stored in a format suitable for research use 5. Availability of post-ESD histopathologic assessment allowing confirmation of the final diagnosis and evaluation of invasion depth (M or SM) 6. Patients prospectively and consecutively enrolled during the study period at participating institutions (consecutive enrollment) 7. Patients who voluntarily provide written informed consent for study participation

Exclusion criteria

Exclusion criteria: Exclusion Criteria (Applicable to All Three Participating Centers) 1. Patients without available histopathologic results or for whom assessment of invasion depth is not possible 2. Poor-quality endoscopic images that preclude adequate lesion evaluation (e.g., out-of-focus images, severe motion artifacts, or limited visualization) 3. Cases in which only incomplete image data are available and the target lesion is not adequately included 4. Patients who have received prior treatment that may affect the assessment of invasion depth, including endoscopic resection, surgery, radiotherapy, or chemotherapy 5. Patients with missing key clinical information or image data required for study conduct 6. Patients deemed unsuitable for study participation by the Principal Investigator

Design outcomes

Primary

MeasureTime frame
Accuracy of the AI model in predicting invasion depth (M vs SM) of esophageal cancer

Secondary

MeasureTime frame
Diagnostic performance of the AI model including sensitivity, specificity, and area under the curve (AUC)

Countries

Korea, Republic of

Contacts

Public ContactHyo Soon Yoo

Samsung Medical Center

hyosoonyoo.cr@gmail.com+82-2-2008-4179

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 23, 2026