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- Klinische proef NCT07629921
Multimodal Al for Precision Diagnosis of Esophageal Cancer
14 augustus 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Werkelijk)
264
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
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Shanghai, China
- Zhongshan hospital
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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
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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
|
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Actual receipt of additional surgery
Tijdsspanne: 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.
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1 week
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Presence of pathological indications for additional surgery
Tijdsspanne: 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
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 maart 2023
Primaire voltooiing (Werkelijk)
1 januari 2026
Studie voltooiing (Werkelijk)
7 juni 2026
Studieregistratiedata
Eerst ingediend
1 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
1 juni 2026
Eerst geplaatst (Werkelijk)
5 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
18 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
14 augustus 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Hoofd- en nekneoplasmata
- Slokdarmaandoeningen
- Slokdarmneoplasmata
- Chirurgische procedures, operatief
- N-acetyltalosaminuronic acid
Andere studie-ID-nummers
- B2026-538R
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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