Multimodal AI for Precision Diagnosis of Esophageal Cancer

NCT07629921 | Active Not Recruiting

• 1 other identifier: B2025-145(2)
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to construct two multimodal deep learning models: one for the diagnosis of esophageal cancer and the prediction of invasive depth to assess suitability for endoscopic resection; the other model, based on this, classifies endoscopic non-resectable patients into different degrees of invasion to further explore the differences in the sensitivity and survival of AI-predicted benign and malignant tumors in patients' responses to NAT, thereby providing reliable decision support for precise individualized treatment. This aspect has rarely been addressed in previous studies.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

• Actual receipt of additional surgery

  Actual receipt of additional surgery was defined as patients who underwent subsequent radical surgical treatment after ESD based on multidisciplinary team (MDT) recommendations, clinician judgment, and patient preference.

  1 week

• Presence of pathological indications for additional surgery

  According to current guidelines, non-curative resection requiring consideration of additional radical treatment was defined by the presence of submucosal invasion (SM2 invasion), or lymphovascular invasion (LVI-positive), or a positive vertical resection margin (VM-positive).

  1 week

Study Arms (3)

NAT +surgery

Other: NAT; Other: surgery

ESD+surgery

Other: ESD; Other: surgery

ESD

Other: ESD

Interventions

NAT OTHER

Neoadjuvant therapy has become a standard treatment strategy for patients with locally advanced esophageal squamous cell carcinoma (ESCC). Administered before surgical resection, neoadjuvant treatment aims to reduce tumor burden, downstage disease, increase the likelihood of complete (R0) resection, and improve long-term survival outcomes. Current neoadjuvant approaches include chemotherapy, chemoradiotherapy, and more recently, immune checkpoint inhibitor-based combination therapies. Among these, neoadjuvant immunochemotherapy has demonstrated promising pathological response rates and survival benefits, emerging as an important treatment option for ESCC. However, treatment response varies considerably among patients, highlighting the need for reliable predictive models to guide individualized therapeutic decision-making.

NAT +surgery

ESD OTHER

Endoscopic submucosal dissection (ESD) is a minimally invasive endoscopic technique used for en bloc resection of superficial gastrointestinal neoplasms. The procedure is performed under conscious sedation or general anesthesia using a therapeutic endoscope. After lesion characterization and marking of the resection margins, a submucosal injection solution (e.g., saline mixed with epinephrine, dye, or viscous agents such as hyaluronic acid) is administered to lift the lesion from the muscularis propria. A circumferential mucosal incision is then made using an endoscopic knife, followed by meticulous submucosal dissection to separate the lesion from the underlying muscle layer. Hemostasis is achieved throughout the procedure using coagulation forceps or hemostatic devices as needed. The lesion is removed en bloc whenever possible, and the resected specimen is retrieved for histopathological evaluation. Post-resection inspection of the artificial ulcer is performed to assess for bleeding

ESD; ESD+surgery

surgery OTHER

Additional surgery refers to esophagectomy with regional lymph node dissection performed after non-curative endoscopic resection. The procedure is recommended for patients with pathological risk factors for lymph node metastasis, including deep submucosal invasion, lymphovascular invasion, positive vertical resection margins, or other non-curative resection criteria. Surgical treatment is performed according to institutional standards and current clinical guidelines.

ESD+surgery; NAT +surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients (≥18 years) with pathologically confirmed esophageal squamous cell carcinoma (ESCC) who underwent diagnostic endoscopy and contrast-enhanced CT examination at participating centers. Patients with early-stage disease who received endoscopic resection or esophagectomy and had pathological assessment of tumor invasion depth will be included for development and validation of a multimodal deep learning model for diagnosis and prediction of invasion depth. Patients with locally advanced disease who received neoadjuvant therapy followed by surgical resection, with available pathological response and follow-up data, will be included for development and validation of a multimodal model for predicting treatment response and prognosis. Clinical information, CT images, endoscopic images, pathological findings, and survival outcomes will be collected for analysis.

You may qualify if:

• Age ≥18 years.
• Histologically confirmed or clinically suspected esophageal squamous cell carcinoma (ESCC).
• Availability of pre-treatment endoscopic images and contrast-enhanced chest/upper abdominal CT scans.
• Availability of complete clinical and pathological data.
• Patients who underwent endoscopic resection (ESD/EMR) or esophagectomy with pathological assessment of tumor invasion depth.
• Adequate image quality for analysis.
• Written informed consent (for prospective cohorts, if applicable).

You may not qualify if:

• Histology other than squamous cell carcinoma.
• Prior treatment for esophageal cancer before baseline imaging, including chemotherapy, radiotherapy, immunotherapy, or endoscopic resection.
• Distant metastatic disease at diagnosis.
• Incomplete clinical, imaging, or pathological data.
• Poor-quality CT or endoscopic images unsuitable for analysis.
• History of another active malignancy within the past 5 years.
• Recurrent esophageal cancer.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

N-acetyltalosaminuronic acid; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: March 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: June 7, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)