Comparative Outcomes of Ulcerative Colitis Patients With Mayo Endoscopic Score 1 and Histologic A… (NCT07188727) | Clinical Trial Compass
CompletedNot Applicable
Comparative Outcomes of Ulcerative Colitis Patients With Mayo Endoscopic Score 1 and Histologic Activity Versus Mayo Endoscopic Score 2
Italy159 participantsStarted 2019-09-01
Plain-language summary
This retrospective study examines patients with ulcerative colitis who initiated advanced therapy for their disease. In clinical practice, patients with only mild inflammation on endoscopy (Mayo Endoscopic Subscore 1, or MES1) often do not undergo treatment optimization or therapy change. We stratified these patients based on histologic findings from biopsy samples and compared them with patients who had greater endoscopic activity (MES2). We evaluated long-term outcomes, including surgery and hospitalization, to determine whether current management strategies for patients with mild endoscopic disease should be reconsidered.
Who can participate
Age range
18 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:
* Confirmed diagnosis of UC (by routine clinical, radiographic, endoscopic and pathologic criteria);
* Patients starting a new advanced treatment for UC (either biologic agents or small molecules);
* Patients with endoscopic MES of 1 or 2 at the endoscopic reassessment (conducted after 12 ± 3 months following the initiation of advanced therapy)
Exclusion Criteria:
* Patients with unclassified colitis or Crohn's disease;
* Previous colonic surgery (eg. Pouch);
* Patients for whom biopsies were not obtained at the time of endoscopic reassessment (conducted after 12 months following the initiation of advanced therapy);
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
Incidence of Composite Outcome
Timeframe: From enrollment to end of follow-up at 36 months