NCT07784114Befejeződött
Incremental Value of Traditional Chinese Medicine Features in Two-Stage Pre-Endoscopic Prediction
Incremental Value of a Traditional Chinese Medicine-Integrated Versus Western-Only Strategy for Two-Stage Pre-Endoscopic Prediction of Colorectal Inflammatory Conditions: A Multicenter Diagnostic Model Development and External Validation Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 25.
Rövid összefoglaló (regiszter, angolul)
This observational study evaluates whether adding Traditional Chinese Medicine (TCM)-related clinical features improves the performance of machine-learning models that estimate disease risk before colonoscopy. We compare two modeling strategies that use the same sequential (two-stage) framework: Western-only models, based on demographic, clinical, and laboratory information commonly used in Western medicine. TCM-integrated models, which use the same types of Western information plus structured TCM features. Stage 1 aims to distinguish people more likely to have functional bowel problems from those more likely to have inflammatory or neoplastic colorectal disease. Stage 2 focuses on people in the higher-risk pathway and aims to distinguish ulcerative colitis from other inflammatory or neoplastic conditions. Models are developed in one dataset and tested in independent external data from other centers. We assess discrimination (including AUC), clinical usefulness with decision-curve analysis, and which TCM features contribute most in the integrated models. This study does not assign treatments. It analyzes existing clinical information to support future pre-endoscopic triage research. Results will not replace colonoscopy or clinician judgment.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 1500 (tényleges)
- Első benyújtás
- 2026. aug. 15.
- Kezdés
- 2015. jan. 1.
- Elsődleges befejezés
- 2025. jún. 1.
- Fő szponzor
- Beijing University of Chinese Medicine
- Betegségek
- Crohn-betegség, Colitis ulcerosa, Vastagbélrák
- NCT-szám
- NCT07784114
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 1500
- 2015. jan. 1. és az elsődleges befejezés (2025. jún. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Életkor
- Age younger than 18 years Missing or unverifiable final diagnostic label required for Stage 1 and/or Stage 2 Missing key predictors required by the Western-only and/or TCM-integrated modeling pipelines (per protocol variable lists) Diagnosis outside the predefined Stage 1 / Stage 2 label sets and not mappable under protocol rules Duplicate or overlapping records for the same patient encounter after de-duplication Records excluded by pre-specified data-quality or center-specific protocol rules (e.g., incomplete critical clinical documentation)
Kiket keres a vizsgálat
- Adults aged 18 years or older Patients evaluated in participating centers with clinical records suitable for pre-endoscopic risk assessment related to colorectal inflammatory or functional bowel conditions Underwent colonoscopy (or had a colonoscopy-confirmed final diagnosis) allowing assignment to the study diagnostic labels used in the two-stage framework Stage 1-eligible diagnoses classifiable as either a functional-predominant pathway (e.g., irritable bowel syndrome / related functional presentations as defined in the protocol) or an inflammatory-neoplastic pathway (ulcerative colitis, Crohn disease, indeterminate colitis, or colorectal neoplasia as defined in the protocol) For Stage 2 analyses: patients within the inflammatory-neoplastic pathway classifiable as ulcerative colitis versus other inflammatory or neoplastic conditions (Crohn disease, indeterminate colitis, or colorectal neoplasia) Availability of required Western clinical and laboratory predictors for model development or validation For TCM-integrated analyses: availability of protocol-defined structured Traditional Chinese Medicine (TCM) features Ability to assign the record to the development cohort or an independent external-validation cohort according to the protocol center rules
Életkor a regiszterben: 18 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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