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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.

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. - VIP study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55753
Enrollment
40
Registered
2017-02-22
Start date
2018-01-23
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Inflammatory bowel disease Primair Scleroserende Cholangitis

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Differences in expression of previously identified potential biomarkers with regard to copy number changes, cancer-relevant gene mutations, methylation status, as well as MIF expression in patients with PSC/IBD versus IBD, stratified by vedolizumab treatment.

Secondary

MeasureTime frame
IIa) Evaluation of potential markers in peripheral blood samples in order to evaluate clinical applicability of the potential markers. IIb) Differences between PSC/IBD and IBD in the identified gene alterations.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)