Correlation of a predefined set of 96 inflammatory proteins between the serum and intestinal tissue within patients with inflammatory bowel disease

ASsoCiation bEtween seRum and Tissue protein profiles in pAtients wIth iNflammatory bowel disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22599

Enrollment

Registered

2017-05-01

Start date

2017-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammatory bowel disease

Interventions

procurement of 5 intestinal biopsies 1 5mL serum tube withdrawal

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients ¡Ý 18 years old 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 a colonoscopy, independent of this study 5. Active disease, defined by either clinical or biochemical AND endoscopic signs: 5.1 Clinical OR biochemical signs of active disease 5.1.1 Clinical: 5.1.1.1 CD: Harvey Bradshaw index (HBI) [21] > 4 5.1.1.2 UC: simple clinical colitis activity index (SCCAI) [22] ¡Ý 5 5.1.2 Biochemical: 5.1.2.1 CRP > 5 mg/L or fecal calprotectin (FC) > 250 mcg/g) AND 5.2 Endoscopic signs of active disease 5.2.1 CD: ¡Ý 1 ulcer ¡Ý 0.5 cm 5.2.2 UC: Mayo score [7] ¡Ý 1

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
To assess the correlation of protein profiles between intestinal tissue and serum in patients with IBD	—

Secondary

Measure	Time frame
To identify the source matrix that has the highest chance to yield clinically relevant IBD biomarkers in future research To identify putative candidate biomarkers that are able to: o differentiate between IBD and non-IBD controls o differentiate between CD and UC o identify subgroups within the patients groups of CD or UC in alignment with endoscopic severity. To identify possible targets for the future development of therapeutic compounds	—

Measure

Time frame

To identify the source matrix that has the highest chance to yield clinically relevant IBD biomarkers in future research To identify putative candidate biomarkers that are able to: o differentiate between IBD and non-IBD controls o differentiate between CD and UC o identify subgroups within the patients groups of CD or UC in alignment with endoscopic severity. To identify possible targets for the future development of therapeutic compounds

—

Contacts

Public ContactToer W. Stevens

Academic Medical Center Amsterdam, Department of gastroenterology and hepatology, C2-231

t.w.stevens@amc.uva.nl(020-56)65584

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)