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Biomarkers voor darmkamer bij pati雗ten met Primair Scleroserende Cholangitis en een inflammatoire darmziekte: de VIP studie


- candidate number28335
- NTR NumberNTR6897
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-dec-2017
- Secondary IDsNL59904.018.16 AMC
- Public TitleBiomarkers voor darmkamer bij pati雗ten met Primair Scleroserende Cholangitis en een inflammatoire darmziekte: de VIP studie
- Scientific TitleVedolizumab 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
- ACRONYMVIP
- hypothesisVedolizumab has chemopreventive properties with regard to colorectal neoplasia (CRN) in the high-risk group of patients with PSC-IBD.
- Healt Condition(s) or Problem(s) studiedPrimary sclerosing cholangitis, Inflammatory bowel disease, Ulcerative Colitis
- Inclusion criteriaGroup 1:
- Diagnosis of PSC, established by cholangiography, in whom secondary causes of sclerosing cholangitis have been excluded
- Concurrent diagnosis of IBD (either UC, CD or IBDU), established at least 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report
- 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

Group 2:
- Diagnosis of IBD (either UC, CD or IBDU), established at least 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report
- Age 18 years and older, either male or female
- Ability to give informed consent
- 10 patients with routine vedolizumab treatment, 10 patients without vedolizumab treatment
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-dec-2017
- planned closingdate1-dec-2022
- Target number of participants40
- InterventionsDuring surveillance endoscopy (scheduled in regular care):
- 8 colonic biopsies
- SES-CD or UCEIS/Mayo score
- 2 blood samples
- 1 fecal sample

In case of PSC-IBD: 3 subsequent surveillance colonoscopies, in case of only IBD: 2 subsequent surveillance colonoscopies.
- Primary outcomeDifferences 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 outcome- Evaluation of potential markers in peripheral blood samples in order to evaluate clinical applicability of the potential markers.
- Differences between PSC/IBD and IBD in the identified gene alterations.
- TimepointsGroup 1: 3 colonoscopies with 1 year in between
Group 2: 2 colonoscopies with approximately 2 years in between
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. Cyriel Y. Ponsioen
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Cyriel Y. Ponsioen
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Takeda
- Publications
- Brief summaryPrimary sclerosing cholangitis (PSC) is a rare chronic inflammatory disease of the biliary tree of unknown cause. Therapy is still limited to treatment of complications, and ultimately leading to bile duct destruction and liver failure. PSC has a strong association with inflammatory bowel disease (IBD), especially ulcerative colitis (UC). The gut homing lymphocyte paradigm offers a plausible explanation linking the gut and liver in PSC, stating that gut-primed t-lymphocytes (expressing 􊨹) can migrate into the liver because of aberrantly expressed adhesion molecules (like MAdCAM-1) and chemokines in the liver. Vedolizumab is a humanized monoclonal antibody, that specifically binds to the lymphocyte integrin 􊨹, thereby impairing the migration of gut-homing lymphocytes into gastrointestinal mucosa and possibly into the liver.
The risk of developing colorectal carcinoma (CRC) is elevated in patients with PSC and concomitant IBD compared to patients with IBD alone, with an estimated cumulative risk of 13% after 30 years. This mandates annual colonoscopic surveillance from the date of diagnosis of PSC, which is a burden for the patients. A clinically useful biomarker assay for early detection of the dysplasia-carcinogenesis sequence could help in surveilling these patients. Previous research showed an increased expression of Macrophage Migration Inhibitory Factor (MIF) in right colonic mucosal tissue of PSC/IBD patients as opposed to IBD-patients. In gastrointestinal cancers, an increase of this inflammatory cytokine is seen. Blocking T-cell influx into the colonic tissue could possibly decrease MIF levels in the colonic mucosa, vedolizumab may play a role in this process.
With this study, we aim to test the hypothesis that vedolizumab has chemopreventive properties with regard to colorectal neoplasia in the high-risk group of patients with PSC/IBD and look into the feasibility of potential biomarkers of risk of development of CRC in PSC/IBD patients.
- Main changes (audit trail)
- RECORD11-dec-2017 - 4-jan-2018


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