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Multimodal AI for Precision Diagnosis of Esophageal Cancer

Multimodal AI for Precision Diagnosis of Esophageal Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07629921
Enrollment
264
Registered
2026-06-05
Start date
2023-03-01
Completion date
2026-06-07
Last updated
2026-06-05

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

Conditions

Esophageal Cancer

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.

Interventions

OTHERNAT

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.

OTHERESD

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

OTHERsurgery

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.

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Actual receipt of additional surgery1 weekActual 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.
Presence of pathological indications for additional surgery1 weekAccording 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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026