- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07629921
Multimodal Al for Precision Diagnosis of Esophageal Cancer
14 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
264
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Shanghai, Kina
- Zhongshan hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Actual receipt of additional surgery
Tidsram: 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
|
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Presence of pathological indications for additional surgery
Tidsram: 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).
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1 week
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2023
Primärt slutförande (Faktisk)
1 januari 2026
Avslutad studie (Faktisk)
7 juni 2026
Studieregistreringsdatum
Först inskickad
1 juni 2026
Först inskickad som uppfyllde QC-kriterierna
1 juni 2026
Första postat (Faktisk)
5 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 augusti 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B2026-538R
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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