pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis

Study Overview
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Brief Summary
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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.

Detailed Description
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After informed consent, patients will undergo endoscopic assessment evaluating endoscopic disease activity using established scoring systems Mayo endoscopic sub-score5 Ulcerative Colitis Endoscopic Index of Severity [UCEIS]6 All endoscopic assessments will be recorded, allowing blinded scoring by independent endoscopists afterwards. Study protocol APOLLO - 2 During endoscopy, colonic biopsies will be taken according to standard of care from the most inflamed area of the colon and normal area if applicable, 0-60cm from the anal verge. All biopsies will be scored histologically using the Nancy Index.7 During the same study visit, clinical symptoms (Simple clinical colitis activity index [SCCAI]) and patient reported outcomes (PROMs) will be evaluated digitally using validated scoring systems8 IBD disk PRO-2 Visual Analogue Scale IBD control in case of non-remission Finally, patients will be biochemically (C-reactive protein, hemoglobin, albumin) evaluated, including measurement of drug level (infliximab, adalimumab, vedolizumab) in case of ongoing exposure to biological agents. All evaluations are part of standard-of-care. Definitions Endoscopic remission: Mayo endoscopic sub-score 0 AND UCEIS 0 Endoscopic response according to Mayo score: decrease in Mayo endoscopic sub-score ≥ 1 UCEIS: decrease in UCEIS ≥ 2 Endoscopic improvement: Mayo endoscopic sub-score 1 Histological remission: Nancy histological index 0 Absence of active/acute histological inflammation: Nancy histological index 0-1 Histological response: Nancy histological index > 1 PRO2 remission: stool frequency ≤ 1 (absolute stool frequency ≤ 3 OR 1-2 stools more than usual) AND rectal bleeding score of 0 (average of 3 days prior to endoscopy) IBD disk remission per item: Abdominal pain Regulating defecation Interpersonal interactions Education and work Sleep Energy Emotions Body Image Sexual function Joint pain

Official Title
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APOLLO Study: pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Diagnostic Test: endoscopic biopsies


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: All patients with ulcerative colitis (≥ 16 years) undergoing planned endoscopic assessment as part of standard of care between 01.07.2020 and 30.06.2021. Evidence of a personally signed and dated informed consent document (ICF) indicating that the subject has been informed of all aspects of the study. EXCLUSION CRITERIA: Subjects with a diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or Crohn's disease. Subjects with clinical findings suggestive of CD (e.g. fistulae, granulomas on biopsy) are also excluded. Similar data collection within 8 weeks prior to endoscopic assessment

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with ulcerative colitis<br>patients with ulcerative colitis and planned endoscopy as part of routine care | Diagnostic Test: endoscopic biopsies<br>* patients with planned endoscopy for ulcerative colitis have endosocpic data recorded aswell as biopsy sampling and blood tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between histological disease activity and disability | histological activity is based on the Nancy score, disability is based on the IBD disk | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between histological disease activity and patient reported outcomes | histological activity is based on the Nancy score, PRO is based on the SCCAI | 1 day | 
| correlation between histological disease activity and patient reported outcomes | histological activity is based on the Nancy score, PRO is based on the VAS | 1 day | 
| correlation between histological disease activity and patient reported outcomes | histological activity is based on the Nancy score, PRO is based on the PRO-2 | 1 day | 
| correlation between histological disease activity and endoscopic disease activity | histological activity is based on the Nancy score, endoscopic disease activityis based on the Mayo endoscopic subscore | 1 day | 
| correlation between histological disease activity and endoscopic disease activity | histological activity is based on the Nancy score, endoscopic disease activity is based on the UCEIS | 1 day | 
| correlation between histological disease activity and biomarkers | histological activity is based on the Nancy score, biomarkers (CRP, hemoglobine, albumin) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulcerative colitis, patient reported outcomes, histological scoring, disability, inflammatory bowel disease