NCT07877636Toborzás még nem indult
Objective Disease Control and Treatment Strategies in Ulcerative Colitis
A Multicenter Longitudinal Cohort Study of Objective Disease Control, Treatment Adaptation, and Long-Term Outcomes in Ulcerative Colitis
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 26.
Rövid összefoglaló (regiszter, angolul)
This multicenter longitudinal observational cohort study aims to characterize objective disease-control trajectories, treatment adaptation, and long-term clinical outcomes among adults with ulcerative colitis receiving routine clinical care. Longitudinal clinical information, laboratory biomarkers, endoscopic assessments, intestinal ultrasound when available, medication exposure, corticosteroid use, hospitalization, surgery, and other clinically relevant events will be integrated to reconstruct time-varying disease states. The primary longitudinal construct is time under objective uncontrolled disease (TUOD), defined as the cumulative proportion of evaluable follow-up time during which objective evidence indicates inadequately controlled ulcerative colitis. Periods without sufficient information to determine objective inflammatory status will be classified separately as unknown or unobservable rather than assumed to represent disease control. The study will also evaluate two prespecified treatment-strategy questions. First, among patients initiating advanced therapy, long-term outcomes will be compared according to the initial advanced-therapy strategy irrespective of subsequent treatment modification or switching. Second, among patients developing confirmed objective disease non-control during advanced therapy, outcomes associated with alternative treatment-adaptation strategies, including within-mechanism optimization and switching to an alternative therapeutic mechanism, will be evaluated. The study is non-interventional. Treatment selection, treatment optimization, switching, diagnostic investigations, and follow-up are determined by treating physicians according to routine clinical practice and are not assigned by the study.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 1000 (tervezett)
- Első benyújtás
- 2026. okt. 9.
- Kezdés
- 2026. nov. 1.
- Elsődleges befejezés
- 2031. dec. 30.
- Fő szponzor
- First Affiliated Hospital, Sun Yat-Sen University
- Betegségek
- Colitis ulcerosa
- NCT-szám
- NCT07877636
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 1000
- 2026. nov. 1. és az elsődleges befejezés (2031. dec. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Ki nem vehet részt
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Más betegség
- Diagnosis subsequently revised to Crohn's disease, isolated intestinal Behçet's disease, infectious colitis, ischemic colitis, or another non-ulcerative-colitis condition that better explains the participant's disease.
- Only an isolated administrative record is available, with no clinical information sufficient to evaluate disease status, treatment, or outcomes.
Egyéb
- Key patient identity information cannot be reliably linked across records, preventing establishment of a longitudinal patient record.
- Duplicate or irreconcilable patient identity records.
- Withdrawal of permission for use of prospectively collected research data, where applicable and where continued use is not otherwise permitted under the approved protocol.
- Any exclusion required by applicable local ethics or regulatory requirements.
Kiket keres a vizsgálat
- Age 18 years or older.
- Established diagnosis of ulcerative colitis based on clinical, endoscopic, histological, imaging, and/or disease-course information documented in routine clinical care.
- Received clinical care at one of the participating centers during the prespecified study period.
- Availability of at least one traceable clinical, examination, hospitalization, or treatment record relevant to ulcerative colitis.
- Availability of sufficient clinical information to establish the participant's ulcerative colitis diagnosis and longitudinal observation period.
- Eligible for inclusion under the ethics-approved retrospective and/or prospective cohort procedures.
Életkor a regiszterben: 16 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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