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NCT07605663Active, not recruiting

an AI-Driven Four-Tier Invasion Depth Classification for Early Esophageal Cancer

Source: ClinicalTrials.gov · Last updated 26 May 2026

Brief summary (registry, in English)

The goal of this retrospective observational study is to evaluate whether preoperative endoscopic imaging can accurately assess tumor invasion depth in patients with early esophageal neoplasia undergoing endoscopic submucosal dissection (ESD). The main question it aims to answer is:"How accurately can preoperative multimodal endoscopic imaging predict histopathological invasion depth in early esophageal squamous cell carcinoma and high-grade intraepithelial neoplasia?" If there is a comparison group: Not applicable (no intervention or arm comparison was specified; analyses are based on diagnostic performance against postoperative pathology as the reference standard). Participants will: * Be retrospectively identified from two tertiary hospitals in China; * Have pathologically confirmed early esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia treated with ESD; * Have complete postoperative pathology data including invasion depth, lesion size, location, lymphovascular invasion, and margin status; * Have preoperative high-quality endoscopic images (white-light imaging, narrow-band imaging, iodine staining, and blue laser imaging); * Undergo retrospective image-pathology correlation analysis to assess diagnostic performance of invasion depth assessment.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
890 (actual)
First submitted
18 May 2026
Start date
1 Jan 2020
Primary completion date
1 Jun 2026
Lead sponsor
Fudan University
NCT number
NCT07605663

What you commit to

  • Study type: Observational
  • Participants enrolled: 890
  • From 1 Jan 2020 to the primary completion date, 1 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous esophageal surgery, neoadjuvant chemoradiotherapy, or other malignant tumors;

Other

  • Poor-quality endoscopic images;
  • Missing pathological invasion depth data;
  • Synchronous distant metastasis.

Who the study is looking for

  • Pathologically confirmed EEC or high-grade intraepithelial neoplasia;
  • Underwent ESD with complete postoperative pathological report;
  • Preoperative high-quality WLI, NBl, iodine staining and BLI endoscopic images;
  • complete clinical data.

Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongshan Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.