Large-scale Models of Esophageal Cancer and Related Research (NCT07642401) | Clinical Trial Compass
By InvitationNot Applicable
Large-scale Models of Esophageal Cancer and Related Research
China12,000 participantsStarted 2026-05-15
Plain-language summary
The goal of this observational study is to learn about the clinical utility of an artificial intelligence (AI) large language model in patients undergoing screening, diagnosis, treatment, and prognosis assessment for esophageal cancer. The main question it aims to answer is:
Does the AI model improve early detection rate, diagnostic accuracy, treatment personalization, and prognostic prediction for esophageal cancer compared to standard care? Participants already receiving routine esophageal cancer management (including endoscopy, imaging, pathology, and clinical follow-up) as part of their regular medical care will have their de-identified data processed by the AI model; researchers will compare model-based recommendations and outcomes with standard care benchmarks over 3 years.
Last updated on Oct 31, 2027
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Aged 18 years or older. 2. Individuals with normal findings or inflammatory changes: endoscopic or pathological reports indicating "no significant abnormalities detected" or changes consistent with inflammation.
3\. Individuals with benign lesions: pathological reports specifying "absence of tumor cells" or a diagnosis consistent with benign lesions.
4\. Individuals with precancerous lesions: pathological reports with a definitive diagnosis of Low-grade Intraepithelial Neoplasia (LGIN) or High-grade Intraepithelial Neoplasia (HGIN).
5\. Individuals with malignant tumors: pathological reports confirming a diagnosis of esophageal squamous cell carcinoma or esophageal adenocarcinoma.
Exclusion Criteria:
* 1\. Diagnostically uncertain: Lack of definitive pathological evidence, or with doubtful clinical diagnosis.
2\. Poor data quality: Low-quality key imaging data (endoscopy, CT) that is unsuitable for analysis (e.g., severe artifacts, missing images).
3\. Severe missingness of key clinical or follow-up data (missing rate \> 20%). 4. Confounding by other malignancies: Presence of other active malignant tumors other than esophageal cancer within 5 years prior to enrollment.
5\. Loss to follow-up: Failure to obtain key survival or recurrence follow-up information in the retrospective cohort.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the ROC curve (AUC) of the multimodal model for diagnosing esophageal cancer, calculated by ROC analysis using pathological biopsy as the gold standard, based on 5-fold cross-validation on the internal validation set.
Timeframe: Up to 3 years
2
Overall accuracy (proportion of correct classifications) of the multimodal model for diagnosing esophageal cancer, derived from the confusion matrix of the model's predictions on the internal validation set, with pathological biopsy as the gold standard.
Timeframe: Up to 3 years
3
Concordance index (C-index) of the multimodal model for predicting overall survival and progression-free survival, derived from Cox proportional hazards model on time-to-event data.
Timeframe: Up to 3 years
Trial details
NCT IDNCT07642401
SponsorThe First Affiliated Hospital of Henan University of Science and Technology