Establishment of Image Database for Early Upper Gastrointestinal Cancer, Precancerous Lesions, and Precancerous Conditions

March 11, 2026 updated by: Jun Pan, Changhai Hospital
The study is designed to collect magnetically-controlled capsule endoscopy (MCE) images, esophagogastroduodenoscopy (EGD) images, CT images, and histopathology results to establish a database for early upper gastrointestinal cancer, precancerous lesions, and precancerous conditions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Images of MCE for UGIC are scarce, limiting the development of corresponding AI diagnostic model. We aim to create an image database with MCE images, EGD images, CT images, and histopathology results, in patients treated by ESD for early upper gastrointestinal cancer, or biopsy for precancerous lesions, and precancerous conditions, so as to facilitate image-based deep learning studies.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200433
        • Recruiting
        • Changhai Hosptial
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Tertiary Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Magnetically-controlled capsule endoscopy (MCE) images, esophagogastroduodenoscopy (EGD) images, and CT images
Time Frame: Prior to ESD or biopsy
Prior to ESD or biopsy
Histopathology results
Time Frame: During ESD or biopsy
During ESD or biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Jun Pan, MD, Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEC2026-069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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