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Completed

NCT Number: NCT07188727

Comparative Outcomes of Ulcerative Colitis Patients With Mayo Endoscopic Score 1 and Histologic Activity Versus Mayo Endoscopic Score 2

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.

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele Hospital

Milan, MI, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Primary outcomes

  1. Incidence of Composite Outcome

    Time frame: From enrollment to end of follow-up at 36 months

    The composite outcome includes any of the following events: escalation of medical therapy, hospitalization related to ulcerative colitis, or surgery related to ulcerative colitis

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Refining Clinical Practice in Ulcerative Colitis: The Prognostic Value of Histologic Remission - A Monocentric Retrospective Study

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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