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A prospective, multi-center clinical study on the application of machine learning-based cytology examination in postoperative follow-up for esophageal cancer resection and endoscopic submucosal dissection for esophageal early cancer

A prospective, multi-center clinical study on the application of machine learning-based cytology examination in postoperative follow-up for esophageal cancer resection and endoscopic submucosal dissection for esophageal early cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093614
Enrollment
Unknown
Registered
2024-12-09
Start date
2025-01-08
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

esophageal carcinoma

Interventions

Gold Standard:Endoscopic examination: All patients will undergo endoscopic examination within 10 days after cytological examination, and the endoscopist is unaware of the sponge cytological results. T
Index test:Accuracy. Sensitivity, SE. Specificity, SP. Positive predicative value, PPV, PV+. negative predictive value, NPV,PV-.

Sponsors

Nanchong Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? Between the ages of 18-75;? Patients who have undergone esophagectomy for esophageal cancer or endoscopic submucosal dissection for early esophageal cancer meet the standards set forth in the "China Esophageal Cancer Screening and Early Diagnosis and Treatment Guidelines";? Sign the informed consent form.

Exclusion criteria

Exclusion criteria: ? patients with anastomotic fistula; ? those with poor physical status who cannot tolerate sponge cytology and gastroscopy; ? those who are unwilling to participate in this trial; ? those with severe cardiopulmonary disorders, coagulation dysfunction, severe anemia, and neoplastic diseases of other organs, which affects the postoperative follow-up.

Design outcomes

Primary

MeasureTime frame
The specificity of AI-based sponge cytology examination;The sensitivity of AI-based sponge cytology examination;The positive predictive value of AI-based sponge cytology examination;The negative predictive value of AI-based sponge cytology examination;INR;Electrocardiogram (ecg);—

Countries

China

Contacts

Public ContactZhang Tao

Nanchong Central Hospital

305514271@qq.com+86 182 2731 2096

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026