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pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis

NCT04990245 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2021-08-04

No results posted yet for this study

Summary

Background and rationale:

In ulcerative colitis, treating beyond endoscopic healing has shown a reduction of relapse and hospitalization, pushing for histological remission in daily clinical practice.1 However, very little is known on how histological remission is associated with patient reported outcomes (PROMs).2,3 In recent years, several questionnaires have been developed to assess what really matters to patients: symptoms and the burden UC exerts on them.4 As PROMs are getting more and more attention during drug development programs and drug approval by international organizations, including FDA and EMA, the link between objective outcome measures (endoscopic, histological, biochemical) and PROMs should therefore be better characterized.

Objectives and design:

To investigate prospectively the association of patient reported outcomes (PROMs) and biochemical, endoscopic and histological outcome measures in patients with ulcerative colitis.

Conditions

Interventions

DIAGNOSTIC_TEST

endoscopic biopsies

patients with planned endoscopy for ulcerative colitis have endosocpic data recorded aswell as biopsy sampling and blood tests

Sponsors & Collaborators

  • Imelda GI Clinical Research Center

    lead OTHER

Principal Investigators

  • Peter Bossuyt, MD · Imelda general hospital

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-07-28
Completion
2021-07-28

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04990245 on ClinicalTrials.gov