Active — Not RecruitingNot Applicable

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

China890 participantsStarted 2020-01-01

Plain-language summary

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.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Poor-quality endoscopic images; * Previous esophageal surgery, neoadjuvant chemoradiotherapy, or other malignant tumors; * Missing pathological invasion depth data; * Synchronous distant metastasis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence of pathological indications for additional surgery

Timeframe: Week1

Actual receipt of additional surgery

Timeframe: Week 1

Trial details

NCT IDNCT07605663

SponsorFudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-01

View on ClinicalTrials.gov More Esophageal Squamous Cell Carcinoma trials