- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07590271
Research on the Whole Process of AI Intelligent Management System for the Diagnosis and Treatment of Inflammatory Bowel Diseases
Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic immune-mediated disorder requiring long-term management. Clinically, IBD may involve recurrent intestinal inflammation, ulcer formation, and complications such as strictures and fistulas. The etiology of IBD is associated with immune dysregulation, gut microbiome imbalance, and genetic susceptibility. Its clinical manifestations are heterogeneous; early symptoms such as abdominal pain, diarrhea, weight loss, hematochezia, or anemia often resemble gastroenteritis, irritable bowel syndrome, or infectious enterocolitis, leading to misdiagnosis and delayed diagnosis. According to international studies, the interval between initial symptom onset and confirmed diagnosis can range from several months to years, during which untreated disease progression increases the risks of hospitalization, surgery, bowel strictures, and fistulizing complications, resulting in significant impacts on patient quality of life.
This study adopts a retrospective design, analyzing our hospital's electronic medical record data from 2023 to 2025.The objective is to evaluate the performance and feasibility of an artificial intelligence (AI) model-developed and incorporating natural language processing (NLP) and phenotypic recognition algorithms-in supporting early identification and diagnosis of IBD. The model has been validated in multiple European healthcare systems and is capable of recognizing high-risk phenotypic clusters from large-scale structured and unstructured medical data. This study represents the first application of this AI technology in the Taiwanese IBD population. All data processing will occur within a de-identified and secure computing environment to ensure data privacy and information security.
The study will compare AI-generated diagnostic suggestions derived from medical records with actual clinical diagnoses to assess consistency and accuracy. The model's performance across different clinical characteristics, disease severity levels, and stages of illness will also be examined. In addition, statistical metrics such as precision and recall will be used to generate PRC curves for determining the optimal diagnostic threshold. The outcomes of this study are expected to validate the potential of AI technology in facilitating early recognition, accelerating diagnosis, and supporting clinical decision-making for IBD. The findings will provide essential data for developing localized AI models for IBD, ultimately enhancing diagnostic efficiency, shortening the diagnostic timeline, and improving long-term patient outcomes and quality of life.
Objective 1:To retrospectively analyze the clinical characteristics and diagnostic pathways of patients with IBD (CD/UC).
Objective 2:To evaluate the performance of the AI model in identifying and providing diagnostic suggestions for high-risk IBD cases.
Objective 3:To compare the accuracy and consistency between AI-generated diagnostic suggestions and actual clinical diagnoses.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Lokalizacje studiów
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Xitun Dist.
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Taichung, Xitun Dist., Tajwan, 407219
- Taichung Veterans General Hospital
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Kontakt:
- Chung Hsin Chang
- Numer telefonu: 3302 886-4-23592525
- E-mail: chunghsin@vghtc.gov.tw
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
Inclusion criteria for the IBD group:
Patients diagnosed with IBD (K50.00 to K51.919) within the specified time interval.
Inclusion criteria for the non-IBD group:
Patients never diagnosed with IBD (K50.00 to K51.919) within the specified time interval.
Exclusion Criteria:
Patients not within the specified time interval Deceased patients
Exclusion criteria for the non-IBD group:
Patients not within the specified time interval Deceased patients Patients with fewer than 5 hospital visits
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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developing localized AI models for IBD
Ramy czasowe: No direct participant involvement; retrospective chart review of medical records from 2023 to 2025 only.
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The findings will provide essential data for developing localized AI models for IBD, ultimately enhancing diagnostic efficiency, shortening the diagnostic timeline, and improving long-term patient outcomes and quality of life.
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No direct participant involvement; retrospective chart review of medical records from 2023 to 2025 only.
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Współpracownicy i badacze
Publikacje i pomocne linki
Publikacje ogólne
- Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Scholmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19.
- Wang HH, Wang YH, Liang CW, Li YC. Assessment of Deep Learning Using Nonimaging Information and Sequential Medical Records to Develop a Prediction Model for Nonmelanoma Skin Cancer. JAMA Dermatol. 2019 Nov 1;155(11):1277-1283. doi: 10.1001/jamadermatol.2019.2335.
- Nguyen PA, Syed-Abdul S, Iqbal U, Hsu MH, Huang CL, Li HC, Clinciu DL, Jian WS, Li YC. A probabilistic model for reducing medication errors. PLoS One. 2013 Dec 3;8(12):e82401. doi: 10.1371/journal.pone.0082401. eCollection 2013.
- Le Berre C, Ricciuto A, Peyrin-Biroulet L, Turner D. Evolving Short- and Long-Term Goals of Management of Inflammatory Bowel Diseases: Getting It Right, Making It Last. Gastroenterology. 2022 Apr;162(5):1424-1438. doi: 10.1053/j.gastro.2021.09.076. Epub 2022 Jan 4.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CE26157A
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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