ASsoCiation bEtween seRum and Tissue protein profiles in pAtients wIth iNflammatory bowel disease: the ASCERTAIN trial

Completed

Conditions: 10017969
Crohn's disease
inflammatory bowel disease
ulcerative colitis

Registration Number: NL-OMON45257

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

1. Patients * 18 years
2. Diagnosis of IBD, based on a combination of history, physical examination, family history, laboratory tests, endoscopy tests including histopathologic examination of mucosal biopsies, imaging studies and occasionally intraoperative findings
3. Written informed consent
4. The clinical indication for an endoscopy (ileo-, colonoscopy, sigmoidoscopy), independent of this study
5. Active disease, defined by either clinical or biochemical and endoscopic signs:
5.1 Clinical OR biochemical:
5.1.1 Clinical: CD: Harvey Bradshaw index (HBI) > 4. UC: simple clinical colitis activity index (SCCAI) * 5.
5.1.2 Biochemical: CRP > 5 mg/L or fecal calprotectin (FC) > 250 mcg/g).
AND
5.2 Endoscopic signs of active disease: CD: * 1 ulcer * 0.5 cm. UC: Mayo score * 1

Exclusion Criteria

1. Age < 18 years at inclusion
2. Ongoing use of anticoagulants that may increase the risk of bleeding when biopsies are taken
3. Currently ongoing malignancy
4. Serious concomitant inflammatory diseases and/or anti-inflammatory treatment(s) that may impair the interpretability of the protein analysis, per investigators* interpretation (e.g. microscopic colitis)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Primary objective:<br /><br>1.2 To assess the correlation of protein profiles between intestinal tissue and<br /><br>serum in patients with IBD</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>2. Secondary Objectives:<br /><br>2.1 To identify the source matrix that has the highest chance to yield<br /><br>clinically relevant IBD biomarkers in future research<br /><br>2.2 To identify putative candidate biomarkers that are able to:<br /><br>2.2.1 differentiate between IBD and non-IBD controls<br /><br>2.2.2 differentiate between CD and UC<br /><br>2.2.3 identify subgroups within the patients groups of CD or UC in alignment<br /><br>with endoscopic severity.<br /><br>2.3 To identify possible targets for the future development of therapeutic<br /><br>compounds</p><br>