Vedolizumab in PSC and concurrent IBD: Searching for the missing link between the gut and the liver and exploration of biomarkers for development of colorectal carcinoma.

Recruiting

• Conditions: 10017969; 10019654; 10017991; Inflammatory bowel disease; Primair Scleroserende Cholangitis

• Registration Number: NL-OMON55753
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Group 1:
- Diagnosis of Primary Sclerosing Cholangitis and concommitant diagnosis of
Inflammatory bowel disease, Group 2:
- Diagnosis of inflammatory bowel disease
- 10 patients with routine vedolizumab treatment, 10 patients without
vedolizumab treatment , Both groups:
- Age 18 years and older, either male or female
- Ability to give informed consent
- Groups will be stratified for the use of thiopurines
- Groups will be stratified for UC, CD and IBDU

Exclusion Criteria

- Medical history of proctocolectomy
- Use of biologic therapy other than vedolizumab within 8 weeks of enrolment
- Inability to give informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Differences in expression of previously identified potential biomarkers with<br /><br>regard to copy number changes, cancer-relevant gene mutations, methylation<br /><br>status, as well as MIF expression in patients with PSC/IBD versus IBD,<br /><br>stratified by vedolizumab treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>IIa) Evaluation of potential markers in peripheral blood samples in order to<br /><br>evaluate clinical applicability of the potential markers.<br /><br>IIb) Differences between PSC/IBD and IBD in the identified gene alterations. </p><br>