Image collection for early upper gastrointestinal cancer and precancerous conditions
Establishment of Image Database for Early Upper Gastrointestinal Cancer, Precancerous Lesions, and Precancerous Conditions
This project will collect capsule endoscopy, endoscopy, CT, and biopsy images from adults with early upper gastrointestinal cancer or precancerous conditions to build an image database to support better image-based diagnosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07462247 on ClinicalTrials.gov |
What this trial studies
This observational effort will gather magnetically-controlled capsule endoscopy (MCE) images, esophagogastroduodenoscopy (EGD) images, CT scans, and corresponding histopathology results from patients undergoing ESD or biopsy for early upper gastrointestinal cancer and precancerous lesions/conditions. Collected images and pathology will be linked and curated to form a standardized database suitable for training and validating image-based deep learning models. Participants must be adults able to consent and tolerate the procedures; standard exclusions apply for capsule retention risk, implanted electromedical devices, pregnancy, and relevant allergies. The work is being conducted at Changhai Hospital and aims to address the current scarcity of MCE image datasets.
Who should consider this trial
Good fit: Adults (age ≥18) referred for endoscopic submucosal dissection for early upper GI cancer or for EGD biopsy of upper GI precancerous lesions/conditions who can undergo the imaging procedures and provide informed consent are ideal candidates.
Not a fit: Patients with swallowing difficulties, suspected intestinal stenosis, implanted electromagnetic devices, pregnancy, or those unwilling/unable to undergo the imaging procedures are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the database could enable more accurate and earlier noninvasive diagnosis by supporting AI tools trained on diverse, well-annotated images.
How similar studies have performed: AI studies using EGD and CT images have shown promising diagnostic results, but MCE image datasets are sparse and combining MCE with linked pathology in a database is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female participants aged ≥ 18 years 2. Patients with early upper gastrointestinal cancer referred for endoscopic submucosal dissection (ESD), or patients with upper gastrointestinal precancerous lesions or precancerous conditions referred for biopsy by esophagogastroduodenoscopy (EGD) 3. Participants who are willing and able to participate in this study, complete all required examinations and follow-up visits, and who have provided written informed consent Exclusion Criteria: 1. Patients who are not eligible for surgery or who refuse any abdominal surgery in case of capsule retention and endoscopic retrieval failure 2. Patients with cardiac pacemaker or other implanted electromedical devices which could interfere with magnetic resonance 3. Suspected or known intestinal stenosis or other known risk factors for capsule retention 4. Patients with dysphagia 5. Pregnancy 6. Allergy to polymeric materials, latex, simethicone, or pronase 7. Patients plan to undergo magnetic resonance imaging examination before excretion of the capsule 8. Patients with any condition that precludes compliance with the study
Where this trial is running
Shanghai
- Changhai Hosptial — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jun Pan, MD — Changhai Hospital
- Study coordinator: Jun Pan, MD
- Email: panjun059@163.com
- Phone: +86-13764598567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.