NCT07078136 Multicenter Observational Study of Multimodal AI for Upper GI Mesenchymal Tumor Diagnosis
| NCT ID | NCT07078136 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huazhong University of Science and Technology |
| Condition | Submucosal Tumor |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2025-07-28 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2025-07-28 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study develops a multimodal AI model using endoscopic ultrasound, white-light endoscopy, and clinical information to support the diagnosis of upper GI mesenchymal tumors and the risk stratification of gastric GISTs.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old * Patients with an upper gastrointestinal subepithelial lesion (SEL) identified by white-light endoscopy and who have completed an endoscopic ultrasound (EUS) examination * Patients with a histopathological diagnosis of GIST confirmed by surgical or endoscopic resection, or other SELs confirmed by surgical resection, EUS-guided sampling, or other biopsy techniques * EUS image quality meets the following quality control standards 1. Equipment requirements: Olympus EU-ME2/ME1 processor (Olympus Medical Systems Corp., Tokyo, Japan); radial EUS scope (GF-UE260/GF-UE240; Olympus, Tokyo, Japan) or linear EUS scope (GF-UCT260/GF-UCT240; Olympus, Tokyo, Japan); miniature probe (UM2R/3R; Olympus, Tokyo, Japan); Pentax ARIETTA 850 processor (Pentax, Tokyo, Japan); radial EUS scope (EG-3670URK, Pentax, Tokyo, Japan); linear EUS scope (EG-3870UT, Pentax, Tokyo, Japan); Fujifilm SU-8000 or SU-9000 processor; linear EUS scope (EG-580UT, Fujifilm, Tokyo, Japan); radial EUS scope (EG-580UR, Fujifilm, Tokyo, Japan) 2. EUS images clearly showing the lesion and surrounding tissue characteristics (at least 5 images or video); must include at least one image of the maximum lesion diameter, one image showing the layer of origin, and one image demonstrating the growth pattern (intraluminal/extraluminal) 3. EUS images must not contain artificial annotations, such as measurement scales, biopsy needles, Doppler signals, or elastography overlays 4. Image resolution must be at least 448 × 448 pixels * WLE (white-light endoscopy) image quality meets the following standards: images must clearly show the lesion location, mucosal features, and margins; at least one close-up and one distant view * Complete clinical data and histopathological reports must be available Exclusion Criteria: * Age \< 18 years old * Absolute contraindications for EUS examination, history of gastric surgery, pregnancy, severe comorbidities, or known allergy to anesthetic agents * EUS examination terminated prematurely due to esophageal stricture, obstruction, large space-occupying lesions, rapid changes in heart rate or respiratory rate, patient intolerance, or excessive residual food * EUS image quality does not meet the required quality control standards * Pathological specimens do not meet diagnostic requirements: insufficient biopsy tissue (only R0 resection specimens are accepted for the GIST group), or incomplete immunohistochemical staining (missing CD117/CD34/DOG-1 expression report for the GIST group) * Pathological results indicate that the lesion is a metastatic tumor originating from another site
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07078136 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Submucosal Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07078136 currently recruiting?
Yes, NCT07078136 is actively recruiting participants. Contact the research team at b.cheng@tjh.tjmu.edu.cn for enrollment information.
Where is the NCT07078136 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07078136 clinical trial?
NCT07078136 is sponsored by Huazhong University of Science and Technology. The trial plans to enroll 130 participants.