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临床试验/KCT0012269
KCT0012269进行中(未招募)不适用

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

Samsung Medical Center0 个研究点目标入组 110 人开始时间: 2026年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
110

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational
观察模型
Cohort, Time Perspective : Prospective, Enrollment : 110, Biospecimen Retention : Not collect nor Archive

入排标准

年龄范围
18(Year) 至 No Limit(—)
性别
All

入选标准

  • (Applicable to All Three Participating Centers)
  • 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
  • Adult patients (aged 19 years or older) who undergo endoscopic submucosal dissection (ESD) for superficial esophageal cancer or suspected superficial esophageal neoplasia
  • Availability of diagnostic endoscopic images obtained before ESD and pre-procedural endoscopic images acquired on the day of ESD
  • Endoscopic image data stored in a format suitable for research use
  • Availability of post-ESD histopathologic assessment allowing confirmation of the final diagnosis and evaluation of invasion depth (M or SM)
  • Patients prospectively and consecutively enrolled during the study period at participating institutions (consecutive enrollment)
  • Patients who voluntarily provide written informed consent for study participation

排除标准

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

研究者

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