Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Multimodal Al for Precision Diagnosis of Esophageal Cancer

14 août 2026 mis à jour par: Quan-Lin Li, Shanghai Zhongshan Hospital
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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Type d'étude

Observationnel

Inscription (Réel)

264

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Shanghai, Chine
        • Zhongshan hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
ESD
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+surgery
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.
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
NAT +surgery
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.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Actual receipt of additional surgery
Délai: 1 week
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
Délai: 1 week
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2023

Achèvement primaire (Réel)

1 janvier 2026

Achèvement de l'étude (Réel)

7 juin 2026

Dates d'inscription aux études

Première soumission

1 juin 2026

Première soumission répondant aux critères de contrôle qualité

1 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 août 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner